CN102652730B - Ointment base, kuh-seng and green tea ointment and preparation method of ointment - Google Patents
Ointment base, kuh-seng and green tea ointment and preparation method of ointment Download PDFInfo
- Publication number
- CN102652730B CN102652730B CN201210088149.0A CN201210088149A CN102652730B CN 102652730 B CN102652730 B CN 102652730B CN 201210088149 A CN201210088149 A CN 201210088149A CN 102652730 B CN102652730 B CN 102652730B
- Authority
- CN
- China
- Prior art keywords
- green tea
- radix sophorae
- sophorae flavescentis
- ointment
- extract
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention provides an ointment base, kuh-seng and green tea ointment and a preparation method of the ointment. The ointment base contains thixotropic agent which is organic montmorillonite, medicament dispersant, mineral oil, polar solvent, lubricating agent and weak water absorption emulsifier. The ointment base and the kuh-seng and green tea ointment are good in thixotropic property and easy to apply, the application properties of the ointment base and the ointment are affected little by the temperature, and the ointment base and the ointment do not have irritation property.
Description
Technical field
The present invention relates to Chinese medicine preparation technical field, relate to particularly ointment base, Radix Sophorae Flavescentis green tea ointment machin its preparation method.More specifically, the purposes and the organo montmorillonite that the invention provides in ointment base, Radix Sophorae Flavescentis green tea ointment, the method for preparing Radix Sophorae Flavescentis green tea ointment, Radix Sophorae Flavescentis green tea ointment infect the Verrucosis that causes, molluscum contagiosum that immunologic hypofunction causes and infect by HPV the solar keratosis causing by HPV medicine in preparation treatment are being prepared the purposes in Radix Sophorae Flavescentis green tea ointment.
Background technology
Chinese medicine is made to ointment, and pharmaceutical preparation stability better, drug release effect is strong, patient is carried out after local topical administration, rapid-action.And ointment base is the important component part of ointment molding and performance drug effect, the composition of substrate and performance can have influence on the physicochemical property of medicine in substrate and the physiological function in skin affected part, its quality and character are very big to the quality influence of ointment, so the selection of substrate is a very important aspect of ointment research.Yet traditional ointment base thixotropy is poor, temperature influence is large, not enough aspect sticking water, drug release.
CN1239669A discloses a kind of Radix Sophorae Flavescentis green tea compositions ointment for the treatment of the condyloma acuminatum causing because of human nipple virus; this ointment base is greasing base; can form closure oil film, lubricated, nonirritant, this has very important protective effect to the very easily oxidized green tea effective ingredient of protection.But this drug ointment water absorption is poor, be difficult for mixing with juice, to discharge penetration poor, directly affected the clinical drug effect of medicine.Meanwhile, the substrate temperature influences such as this ointment vaseline used are larger, cause that ointment hardness is large, thixotropy is poor when temperature is low.
Therefore, current ointment base still haves much room for improvement.
Summary of the invention
The following discovery of the present invention based on inventor completes:
Sophora flavescens ait has heat clearing and damp drying, and the effect of wind dispelling insecticide is used for the diseases such as skin ulcer, scabies, tinea disease, main damp-heat dysentery, discharging fresh blood stool, jaundice, dysuria, edema, leukorrhagia, pudendal pruritus, scabies, leprosy, skin pruritus, noxious dampness skin infection.Green tea has heat-clearing and toxic substances removing, effect such as convergence dehumidifying etc., and proving after deliberation, and green tea also has antiviral, antibacterial, antioxidation, anti-proliferative effect.Sophora flavescens ait green tea is prepared into ointment, can treat by HPV and infect the Verrucosis causing, the molluscum contagiosum that immunologic hypofunction causes and the solar keratosis being caused by HPV infection, but current Radix Sophorae Flavescentis green tea ointment water absorption is poor, be difficult for mixing with juice, to discharge penetration poor, the clinical drug effect of medicine is relatively poor, and, current Radix Sophorae Flavescentis green tea ointment temperature influence is larger, causes that ointment hardness is large, thixotropy is poor when temperature is low, is difficult for coating.
The present invention is intended at least solve one of technical problem existing in prior art.For this reason, the invention provides ointment base, Radix Sophorae Flavescentis green tea ointment machin its preparation method.
According to an aspect of the present invention, the invention provides a kind of ointment base.According to embodiments of the invention, this ointment base comprises: thixotropic agent, and it is organo montmorillonite; Medicine dispersant; Mineral oil; Polar solvent; The weak emulsifying agent of lubricant and water suction.Good, the easy coating of ointment base thixotropy of the present invention, stretchability temperature influence are little, nonirritant, and medicine is had to good release action, better stability of preparation.
According to embodiments of the invention, in ointment base of the present invention, thixotropic agent organo montmorillonite can be for being selected from least one of Organic Montmorillonitewith Sodium Laurylsulfonate, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid, preferably Organic Montmorillonitewith Sodium Laurylsulfonate and hexadecyltrimethylammonium chloride modified montmorillonoid.
Organo montmorillonite is a kind of good thixotropic agent, can be by montorillonite clay is carried out to organically-modified preparation.The basic structural unit of montorillonite clay is to be clipped in by a slice alumina octahedral the layer structure forming by sharing oxygen atom between two silicon-oxy tetrahedrons.In these sheet surfaces, there is superfluous negative charge, can Liquidity limit, and the end face of montorillonite clay is with variable charge, adsorbable anion again under certain condition.Thereby, for example dodecyl sodium sulfate (SDS), cationic surfactant cetyl trimethyl ammonium bromide (CTAB) and hexadecyltrimethylammonium chloride (CTAC), as intercalator, obtain organo montmorillonite thereby natural montmorillonite is carried out to intercalation modifying can to use anion surfactant.Montorillonite clay its interlayer after organic-treating becomes lipophilic-hydrophobic property from hydrophilic oleophobic property, has strengthened montorillonite clay and the organic compatibility and dispersibility.The dispersibility of montorillonite clay after organic-treating in organic facies significantly improves, and shows good swellability, dispersibility and thixotropy, and temperature influence is little.About can be referring to the detailed description of organo montmorillonite preparation method: 1. old sea group, etc. the preparation of Organic Montmorillonitewith Sodium Laurylsulfonate and sign, Chinese Journal of Inorganic Chemistry, 2004,20 (3): 251-256; 2. Wang Yi, etc. the preparation of novel organo montmorillonite, structural characterization and dispersibility thereof, Henan chemical industry, 2006,23 (7): 8-11; 3. Lee's wind rises. and different surfaces activating agent is prepared organo montmorillonite, application chemical industry, 2008,37 (4): 424-426; 4. Zheng Quan becomes, etc. the research of the loose organic montmorillonite of oversubscription, Lanzhou Jiaotong University's journal, 2009,28 (1): 93-96, is incorporated to it herein in full by reference.
According to embodiments of the invention, in ointment base of the present invention, mineral oil can be for being selected from least one of liquid paraffin and soft paraffin, preferred liquid paraffin.Inventor finds, adopt the ointment of preparing containing the oil ointment base of liquid paraffin of the present invention, there is oil sealing effect, the effective ingredient that can solve in ointment is unstable, easy oxidized problem, and can effectively extend resting period of ointment, the effective ingredient that makes ointment is through depositing of long period and not oxidized, further, ointment base of the present invention has good prospect in the application aspect of labile drug.
According to embodiments of the invention, in ointment base of the present invention, polar solvent can be for being selected from least one of glycerol, propylene glycol and ethanol, preferably glycerine, the organo montmorillonite that adopts different organic modifiers to prepare is subject to the polarity alcohols solvent activation influence degree of hydroxyl different, and inventor finds, glycerol, propylene glycol and ethanol add the viscosity that can promote gel rubber system, the consumption that reduces organo montmorillonite, obtains more stable gel effect.
Inventor is surprised to find, the present invention adopts the organo montmorillonite preparing through the montorillonite clay of ionic surface active agent modified natural, disperse mineral oil and polar solvent, the thixotropic agent mineral oil gel obtaining, gel rubber system is uniform and stable, there is high thixotropic, medicine high dispersive, the feature that stretchability temperature influence is less, thereby, main material using it as ointment base, can there is good release action to medicine, and solve and take the defect that traditional ointment base thixotropy is poor, temperature influence is large that lanoline or vaseline etc. are main component.Further, according to concrete example of the present invention, adopt thixotropic agent mineral oil gel as the main material of ointment base, to replace vaseline and lanoline in traditional ointment base, prepare Radix Sophorae Flavescentis green tea ointment, can significantly improve the thixotropy of prepared ointment, and play thickening power, thereby organo montmorillonite can be there is to this character of good thixotropy, be successfully incorporated in ointment.
According to embodiments of the invention, in ointment base of the present invention, medicine dispersant can be for being selected from least one of Polyethylene Glycol-300 and polypropylene glycol-500, and preferably, medicine dispersant is Polyethylene Glycol-300 or polypropylene glycol-500.Thus, ointment base of the present invention can make medicine effectively disperse.
According to embodiments of the invention, in ointment base of the present invention, lubricant can, for being selected from least one of isopropyl myristate, n-butyl stearate, Cyclomethicone, acetyl monoglyceride and cetostearyl alcohol, be preferably the mixture of isopropyl myristate and Cyclomethicone.Inventor finds, isopropyl myristate, is a kind of low-carbon-ester of higher fatty acids, has good lubricity, permeability, can improve the affinity to skin, and it is low that its greasy feeling of while is compared other ointment bases; Cyclomethicone, has the features such as the coating of being easy to, good, the good permeability of antistatic property, chemical stability are good, and its high volatile volatile and medium solvent characteristics become the key component of ideal topical preparation.This is because its high volatile volatile and medium solvent characteristics can make ointment produce low heat of evaporation at agents area, therefore, use the skin of the special agents area of this ointment can not produce the moist sensation that oil ointment base oil sealing brings.
Inventor finds, the ointment that a large amount of liquid paraffin that exist in ointment base of the present invention can cause adopting ointment base of the present invention to prepare has the problem of lubricity deficiency, thereby affect the coating of ointment, and adopt the mixture of isopropyl myristate and Cyclomethicone as lubricant, head it off effectively, and can reduce the moist sensation of greasy feeling and the agents area of ointment.
According to embodiments of the invention, in ointment base of the present invention, the weak emulsifying agent of water suction can be for being selected from least one of stearyl alcohol and glyceryl monostearate, preferably stearyl alcohol.Thus, ointment base of the present invention, can regulate the water absorption and the drug release rate that adopt its ointment of preparing effectively.Inventor finds, in ointment base, add the weak emulsifying agent of water suction, can significantly improve the sticking outlet capacity that adopts ointment prepared by this ointment base, make ointment can absorb in time mixing in the situation that agents area has a small amount of juice to ooze out, can also significantly improve the water permeability of ointment simultaneously, can be when promoting skin hydration effect contained hydrophilic polyglycol or polypropylene glycol absorption portion water in binding matrix, greatly accelerated the rate of release of medicine, efficiently solve the poor problem of common oil ointment base release, and increased the washability of medicine.
According to embodiments of the invention, in ointment base, the ratio of each composition is not particularly limited.According to concrete example of the present invention, ointment base can comprise the medicine dispersant of 100-200 weight portion, the thixotropic agent of the mineral oil of 400-600 weight portion, 20-60 weight portion, the weak emulsifying agent of the lubricant of the polar solvent of 10-30 weight portion, 200-300 weight portion and the water suction of 50-100 weight portion.
According to concrete examples more of the present invention, the pseudoplastic fluid that ointment base of the present invention is suitable denseness, has certain yield value, thinning when shearing or rub, and easily coats, and shears the rapid viscosity that recovers it while stopping.In addition, inventor is surprised to find, ointment base of the present invention has high thixotropic, medicine high dispersive, feature that stretchability temperature influence is less, all can keep semi-fluid condition, and do not occur the situation that ointment is really up to the mark or excessively rare under 0 ℃, 25 ℃, 40 ℃ conditions.Thus, ointment base of the present invention has improved the defect that general ointment base thixotropy is poor, temperature influence is large, when playing medicine had to good release action, reduced the sensitivity of ointment to temperature, strengthened the thixotropy of ointment, also the application of aqueous solution labile drug has been had to good prospect simultaneously.
According to another aspect of the present invention, the invention provides a kind of Radix Sophorae Flavescentis green tea ointment.According to embodiments of the invention, this Radix Sophorae Flavescentis green tea ointment packets contains: Radix Sophorae Flavescentis or Radix Sophorae Flavescentis extract, and this Radix Sophorae Flavescentis extract is the water extract of Radix Sophorae Flavescentis; Green tea or green tea extract, this green tea extract is the alcohol extract of green tea; And ointment base of the present invention.Inventor is surprised to find, and Radix Sophorae Flavescentis green tea ointment of the present invention can treat or prevent to infect the Verrucosis causing, the molluscum contagiosum that immunologic hypofunction causes and the solar keratosis being caused by HPV infection by HPV effectively.Wherein, solar keratosis is a kind of skin precancerous lesion.According to concrete example of the present invention, Radix Sophorae Flavescentis green tea ointment of the present invention, homogeneous exquisiteness, good, the easy coating of thixotropy, color and luster uniformity, denseness are suitable, nonirritant, use be without greasy feeling and moist sensation, drug release effect is strong, better stability of preparation, can the resting period long, and can by commercial production, prepare easily.
According to embodiments of the invention, Radix Sophorae Flavescentis extract is prepared through the following steps: Radix Sophorae Flavescentis is carried out to extracting in water, to obtain Radix Sophorae Flavescentis extractive liquid; Radix Sophorae Flavescentis extractive liquid is concentrated, to obtain Radix Sophorae Flavescentis concentrated solution; Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator; And the Radix Sophorae Flavescentis concentrated solution through pH regulator is carried out to purification, to obtain Radix Sophorae Flavescentis extract.According to some embodiments of the present invention, Radix Sophorae Flavescentis is carried out to extracting in water, may further include: Radix Sophorae Flavescentis is carried out to decocting in water 2-4 time with the water of 6-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain Radix Sophorae Flavescentis extractive liquid.According to embodiments of the invention, the relative density of Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees Celsius is 1.06～1.08.According to some embodiments of the present invention, can utilize hydrochloric acid that Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator, wherein, the pH of the Radix Sophorae Flavescentis concentrated solution of process pH regulator is 2-5.According to embodiments of the invention, can utilize cation exchange resin to carry out purification to Radix Sophorae Flavescentis concentrated solution.
According to embodiments of the invention, green tea extract is prepared through the following steps: green tea is added to alcohol extraction, to obtain green tea extractive liquor; And green tea extractive liquor is carried out to purification, to obtain green tea extract.According to some embodiments of the present invention, green tea is added to alcohol extraction and may further include: green tea is carried out to heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain green tea extractive liquor.According to concrete example of the present invention, green tea extractive liquor is carried out to purification and may further include: green tea extractive liquor is carried out to reduced pressure treatment, to remove ethanol; Green tea extractive liquor is carried out to macroporous resin column processing, to obtain purified green tea extractive liquor.
Particularly, according to one embodiment of present invention, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent of Radix Sophorae Flavescentis, green tea, medicine dispersant, mineral oil, thixotropic agent, polar solvent, lubricant and water suction.According to another embodiment of the invention, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent of Radix Sophorae Flavescentis extract, green tea extract, medicine dispersant, mineral oil, thixotropic agent, polar solvent, lubricant and water suction.
In addition, according to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, thixotropic agent organo montmorillonite can be for being selected from least one of Organic Montmorillonitewith Sodium Laurylsulfonate, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid, preferably Organic Montmorillonitewith Sodium Laurylsulfonate and hexadecyltrimethylammonium chloride modified montmorillonoid.Thus, Radix Sophorae Flavescentis green tea ointment thixotropy of the present invention is good, and temperature influence is little.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, mineral oil can be for being selected from least one of liquid paraffin and soft paraffin, preferred liquid paraffin.Thus, Radix Sophorae Flavescentis green tea ointment of the present invention, has oil sealing effect, can make the stable effective ingredients in ointment, is difficult for oxidizedly, and then can effectively extend resting period of ointment.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, polar solvent can be for being selected from least one of glycerol, propylene glycol and ethanol, preferably glycerine.Thus, can promote the viscosity of gel rubber system, reduce the consumption of organo montmorillonite, obtain more stable gel effect.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, medicine dispersant can be for being selected from least one of Polyethylene Glycol-300 and polypropylene glycol-500, and preferably, medicine dispersant is Polyethylene Glycol-300 or polypropylene glycol-500.Thus, Radix Sophorae Flavescentis green tea ointment of the present invention can make medicine effectively disperse.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, lubricant can, for being selected from least one of isopropyl myristate, n-butyl stearate, Cyclomethicone, acetyl monoglyceride and cetostearyl alcohol, be preferably the mixture of isopropyl myristate and Cyclomethicone.Thus, Radix Sophorae Flavescentis green tea soft grease lubrication of the present invention is good, is easy to coating, and can effectively reduce the moist sensation of greasy feeling and the agents area of ointment.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, the weak emulsifying agent of water suction can be for being selected from least one of stearyl alcohol and glyceryl monostearate, preferably stearyl alcohol.Thus, Radix Sophorae Flavescentis green tea ointment water absorption of the present invention and drug release rate are good, and washability is good.
According to embodiments of the invention, according to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis extract 42-84 weight portion, green tea extract 50-100 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and water suction.According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment, can use Radix Sophorae Flavescentis and green tea to substitute respectively Radix Sophorae Flavescentis green tea extract and green tea extract.Thus, according to a concrete example of the present invention, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis 1500-3000 weight portion, green tea 500-1000 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and water suction.
According to a concrete example of the present invention, according to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 76 weight portions, green tea extract 90 weight portions, polypropylene glycol-500 180 weight portion, liquid paraffin 500 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 40 weight portions, glycerol 20 weight portions, isopropyl myristate 180 weight portions, Cyclomethicone 50 weight portions, stearyl alcohol 70 weight portions.
According to a concrete example of the present invention, according to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 70 weight portions, green tea extract 86 weight portions, Polyethylene Glycol-300 140 weight portion, liquid paraffin 450 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 50 weight portions, glycerol 25 weight portions, isopropyl myristate 200 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 55 weight portions.
According to a concrete example of the present invention, according to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 75 weight portions, green tea extract 95 weight portions, Polyethylene Glycol-300 200 weight portion, liquid paraffin 400 weight portions, hexadecyltrimethylammonium chloride modified montmorillonoid 60 weight portions, ethanol 30 weight portions, n-butyl stearate 270 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 50 weight portions
According to a concrete example of the present invention, according to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 42 weight portions, green tea extract 50 weight portions, polypropylene glycol-500 100 weight portion, liquid paraffin 600 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 30 weight portions, glycerol 10 weight portions, isopropyl myristate 170 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 100 weight portions.
According to a concrete example of the present invention, according to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 84 weight portions, green tea extract 100 weight portions, Polyethylene Glycol-300 150 weight portion, liquid paraffin 480 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 20 weight portions, glycerol 15 weight portions, isopropyl myristate 240 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 80 weight portions.
According to embodiments of the invention, inventor utilizes ointment base of the present invention and Radix Sophorae Flavescentis green tea ointment to carry out skin hypersensitivity experiment, and experimental result shows, ointment base of the present invention and with the Radix Sophorae Flavescentis green tea ointment of this matrix composition to guinea pig skin without sensitization.
According to another aspect of the invention, the invention provides a kind of method of preparing Radix Sophorae Flavescentis green tea ointment.According to embodiments of the invention, the method comprises: prepare Radix Sophorae Flavescentis extract, this Radix Sophorae Flavescentis extract is water extract; Prepare green tea extract, this green tea extract is alcohol extract; And use ointment base of the present invention, Radix Sophorae Flavescentis extract and green tea extract are made to Radix Sophorae Flavescentis green tea ointment.Inventor finds, utilize the method for preparing Radix Sophorae Flavescentis green tea of the present invention, can prepare easily and effectively Radix Sophorae Flavescentis green tea ointment, and the method is simple, efficiency is high, can be applied to large-scale industrialization produces, the homogeneous exquisiteness of ointment, the thixotropy that obtain be good, be easy to coating, color and luster uniformity, denseness are suitable, nonirritant, use be without greasy feeling and moist sensation, drug release effect is strong, better stability of preparation, can the resting period long.
According to embodiments of the invention, prepare Radix Sophorae Flavescentis extract and may further include the following step: Radix Sophorae Flavescentis is carried out to extracting in water, to obtain Radix Sophorae Flavescentis extractive liquid; Radix Sophorae Flavescentis extractive liquid is concentrated, to obtain Radix Sophorae Flavescentis concentrated solution; Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator; And the Radix Sophorae Flavescentis concentrated solution through pH regulator is carried out to purification, to obtain Radix Sophorae Flavescentis extract.According to some embodiments of the present invention, Radix Sophorae Flavescentis is carried out to extracting in water, may further include: Radix Sophorae Flavescentis is carried out to decocting in water 2-4 time with the water of 6-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain Radix Sophorae Flavescentis extractive liquid.According to embodiments of the invention, the relative density of Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees Celsius is 1.06～1.08.According to some embodiments of the present invention, can utilize hydrochloric acid that Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator, wherein, the pH of the Radix Sophorae Flavescentis concentrated solution of process pH regulator is 2-5.According to embodiments of the invention, can utilize cation exchange resin to carry out purification to Radix Sophorae Flavescentis concentrated solution.
According to embodiments of the invention, prepare green tea extract and may further include the following step: green tea is added to alcohol extraction, to obtain green tea extractive liquor; And green tea extractive liquor is carried out to purification, to obtain green tea extract.According to some embodiments of the present invention, green tea is added to alcohol extraction and may further include: green tea is carried out to heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain green tea extractive liquor.According to concrete example of the present invention, green tea extractive liquor is carried out to purification and may further include: green tea extractive liquor is carried out to reduced pressure treatment, to remove ethanol; Green tea extractive liquor is carried out to macroporous resin column processing, to obtain purified green tea extractive liquor.
According to embodiments of the invention, Radix Sophorae Flavescentis extract and described green tea extract are made to ointment be may further include: by Radix Sophorae Flavescentis extract and green tea extract respectively with medicine dispersant, to obtain Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid; Thixotropic agent is dissolved in to mineral oil and carries out the first dispersion treatment, to obtain thixotropic agent mineral oil mixture; In the thixotropic agent mineral oil mixture obtaining, add polar solvent and carry out the second dispersion treatment, to obtain thixotropic agent mineral oil gel; To adding successively emulsifying agent a little less than Radix Sophorae Flavescentis extract medicine dispersion liquid, green tea extract medicine dispersion liquid, lubricant and water suction in the thixotropic agent mineral oil gel of gained, mix homogeneously, to obtain Radix Sophorae Flavescentis green tea ointment.
Wherein, according to concrete example of the present invention, the first and second dispersion treatment be one of at least in colloid mill, to carry out wet grinding dispersion, preferably, the first and second dispersion treatment are all in colloid mill, to carry out wet grinding dispersion.Thus, in the thixotropic agent mineral oil gel that can make to obtain, each component is disperseed effectively, and gel rubber system is even, stable.Its concrete principle is: thin layer that organo montmorillonite is agglomeration heap, add after organic solvent, and solvent infiltrates capillary gap and moistening and then make the depolymerization of thin layer heap, causes the viscosity of system to increase.And the dispersibility of raising organo montmorillonite in organic solvent, can significantly improve gel strength, thixotropy and the heat stability performance of organo montmorillonite, further can improve the thixotropy of the thixotropic agent mineral oil gel, ointment base and the ointment that adopt this organo montmorillonite.In addition, the dispersion of organo montmorillonite in organic solvent, generally adopts and stirs or in larger space, utilize mechanical rotation to form high speed shear and carry out.This method only has simple shearing force, be only reinforced dispersed with stirring, and viscous shear space is larger, cannot obtain higher, the more stable gel rubber system of dispersion.According to concrete examples more of the present invention, inventor is surprised to find, and adopts colloid milling, carries out wet grinding and disperse the thixotropic agent mineral oil gel preparing in colloid mill, and gel rubber system is even, stable, and effect is very good.This be because, when organo montmorillonite and organic solvent are disperseed in colloid mill, by the rotor of colloid mill and stator cooperatively interacted dispersion, the emulsifying and homogeneous of material, what organo montmorillonite and organic solvent were suffered is not the effect of single shearing force, but the combined effect of the various physical force such as powerful shearing force, frictional force, dither, high speed whirlpool, therefore resulting dispersion not only has dispersed with stirring effect, also has grinding distribution effect simultaneously, resulting gel rubber system is more even thus, more stable.
According to embodiments of the invention, in thixotropic agent mineral oil gel, add before Radix Sophorae Flavescentis extract medicine dispersion liquid, may further include thixotropic agent mineral oil gel is heated.According to concrete example of the present invention, Radix Sophorae Flavescentis extract and green tea extract are made to ointment and may further include the step that lubricant and the weak emulsifying agent of water suction are carried out to preheating.
Particularly, according to embodiments of the invention, Radix Sophorae Flavescentis extract and green tea extract are made to Radix Sophorae Flavescentis green tea ointment be may further include: Radix Sophorae Flavescentis extract, green tea extract is even with medicine dispersant respectively, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid, green tea extract medicine dispersion liquid; Thixotropic agent is dissolved in to mineral oil, is placed in colloid mill wet grinding and disperses 5-10 minute, after fully disperseing, to obtain thixotropic agent mineral oil mixture; In thixotropic agent mineral oil mixture, add polar solvent, continue to disperse 3-5 minute, to obtain thixotropic agent mineral oil gel; Thixotropic agent mineral oil gel is heated to 60-70 degree Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the lubricant and the weak emulsifying agent of water suction that are preheated to 55-65 degree Celsius, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, to obtain Radix Sophorae Flavescentis green tea ointment.
Particularly, according to some embodiments of the present invention, the method for preparing Radix Sophorae Flavescentis green tea ointment of the present invention can comprise the following steps:
A. take the Radix Sophorae Flavescentis of recipe quantity, add the water of 6-12 times of volume at every turn, decoct 2-4 time, each 0.5-2 hour, merge extractive liquid,, filters, and being concentrated into relative density is the concentrated solution of 1.06～1.08 (50 ℃).Add hydrochloric acid adjust pH to 2-5, filter, supernatant is crossed 732 type cation exchange resin columns, with the 15-40% ethanol remove impurity of water and the 4-8 times of resin volume of 8-12 times of resin volume, again with 1-3 times of resin volume strong aqua ammonia alkalization resin, with 4-10 times of resin volume 15-40% ethanol elution.Eluent is through concentrating under reduced pressure, and drying under reduced pressure, pulverizes, and obtains Radix Sophorae Flavescentis extract fine powder.
B. take the green tea of recipe quantity, add 50-60 ℃ of heating and refluxing extraction of 40-80% ethanol 1-3 time that 8-12 doubly measures, each 0.5-2h, merge extractive liquid, filter, the concentrated ethanol of removing of filtrate decompression, add medical material weight 1-3 water dissolution doubly and extract extractum, centrifugal, discard residue, D101 type macroporous resin column on supernatant, first use the water elution remove impurity of 4-8 column volume, use again the 10-30% ethanol elution remove impurity of 4-8 column volume, finally with the ethanol elution of the 60-95% of 6-12 times of resin volume, by eluent concentrating under reduced pressure, drying under reduced pressure, pulverize, obtain green tea extract fine powder.
C. Radix Sophorae Flavescentis extract fine powder and medicine dispersant are at room temperature ground 5 minutes, until grind evenly, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Green tea extract fine powder and medicine dispersant are at room temperature ground 5 minutes, until grind evenly, obtain green tea extract medicine dispersion liquid.Then, the thixotropic agent that takes recipe quantity is dissolved in mineral oil, be placed in colloid mill wet grinding and disperse 5-10 minute, after fully disperseing, add polar solvent to continue to disperse 3-5 minute, obtain thixotropic agent mineral oil gel, be heated and remain 60-70 degree Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the lubricant and the weak emulsifying agent of water suction that are preheated to 55-65 degree Celsius, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, to obtain Radix Sophorae Flavescentis green tea ointment.
According to embodiments of the invention, according to parts by weight, the method for preparing Radix Sophorae Flavescentis green tea ointment of the present invention can adopt: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis 1500-3000 weight portion, green tea 500-1000 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and water suction.According to embodiments of the invention, also can directly use Radix Sophorae Flavescentis extract or green tea extract, thus, according to embodiments of the invention, the method for preparing Radix Sophorae Flavescentis green tea ointment of the present invention can adopt: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis extract 42-84 weight portion, green tea extract 50-100 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and water suction.
According to a concrete example of the present invention, the method can adopt Polyethylene Glycol-300 as medicine dispersant, adopt liquid paraffin as mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as thixotropic agent, adopt glycerol as polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as lubricant, adopt stearyl alcohol as the weak emulsifying agent of water suction, and according to parts by weight, the ratio of described raw material is: Radix Sophorae Flavescentis 2700 weight portions, green tea 900 weight portions, Polyethylene Glycol-300150 weight portion, liquid paraffin 450 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 40 weight portions, glycerol 20 weight portions, isopropyl myristate 230 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 70 weight portions.
According to a concrete example of the present invention, the method can adopt polypropylene glycol-500 as medicine dispersant, adopt liquid paraffin as mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as thixotropic agent, adopt glycerol as polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as lubricant, adopt stearyl alcohol as the weak emulsifying agent of water suction, and according to parts by weight, the ratio of described raw material is: Radix Sophorae Flavescentis 2450 weight portions, green tea 860 weight portions, polypropylene glycol-500130 weight portion, liquid paraffin 480 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 50 weight portions, glycerol 25 weight portions, isopropyl myristate 200 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 55 weight portions.
According to a concrete example of the present invention, the method can adopt Polyethylene Glycol-300 as medicine dispersant, adopt liquid paraffin as mineral oil, adopt hexadecyltrimethylammonium chloride modified montmorillonoid as thixotropic agent, adopt ethanol as polar solvent, adopt the mixture of n-butyl stearate and Cyclomethicone as lubricant, adopt stearyl alcohol as the weak emulsifying agent of water suction, and according to parts by weight, the ratio of described raw material is: Radix Sophorae Flavescentis 2500 weight portions, green tea 1000 weight portions, Polyethylene Glycol-300200 weight portion, liquid paraffin 400 weight portions, hexadecyltrimethylammonium chloride modified montmorillonoid 60 weight portions, ethanol 30 weight portions, n-butyl stearate 270 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 50 weight portions
According to a concrete example of the present invention, the method can adopt polypropylene glycol-500 as medicine dispersant, adopt liquid paraffin as mineral oil, adopt hexadecyltrimethylammonium chloride modified montmorillonoid as thixotropic agent, adopt ethanol as polar solvent, adopt the mixture of n-butyl stearate and Cyclomethicone as lubricant, adopt stearyl alcohol as the weak emulsifying agent of water suction, and according to parts by weight, the ratio of described raw material is: Radix Sophorae Flavescentis 1500 weight portions, green tea 500 weight portions, polypropylene glycol-500100 weight portion, liquid paraffin 600 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 30 weight portions, glycerol 10 weight portions, isopropyl myristate 170 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 100 weight portions.
According to a concrete example of the present invention, the method can adopt Polyethylene Glycol-300 as medicine dispersant, adopt liquid paraffin as mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as thixotropic agent, adopt glycerol as polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as lubricant, adopt stearyl alcohol as the weak emulsifying agent of water suction, and according to parts by weight, the ratio of described raw material is: Radix Sophorae Flavescentis 3000 weight portions, green tea 1000 weight portions, Polyethylene Glycol-300160 weight portion, liquid paraffin 450 weight portions, Organic Montmorillonitewith Sodium Laurylsulfonate 20 weight portions, glycerol 15 weight portions, isopropyl myristate 240 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 80 weight portions.
According to another aspect of the invention, the invention provides the basis prepared Radix Sophorae Flavescentis green tea ointment of the method for preparing Radix Sophorae Flavescentis green tea ointment of the embodiment of the present invention above.
In accordance with a further aspect of the present invention, the invention provides the purposes in the medicine that is infected the Verrucosis that causes, molluscum contagiosum that immunologic hypofunction causes by HPV and infect by HPV the solar keratosis causing in preparation prevention and treatment according to the Radix Sophorae Flavescentis green tea ointment of the embodiment of the present invention.
According to a further aspect in the invention, the invention provides the purposes of organo montmorillonite in preparing Radix Sophorae Flavescentis green tea ointment.According to embodiments of the invention, this Radix Sophorae Flavescentis green tea ointment is for preventing and treating by HPV and infect the Verrucosis causing, the molluscum contagiosum that immunologic hypofunction causes and the solar keratosis being caused by HPV infection.According to concrete example of the present invention, organo montmorillonite can be for being selected from least one of Organic Montmorillonitewith Sodium Laurylsulfonate, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid, preferably Organic Montmorillonitewith Sodium Laurylsulfonate and hexadecyltrimethylammonium chloride modified montmorillonoid.According to embodiments of the invention, the purposes of organo montmorillonite noted earlier in preparing Radix Sophorae Flavescentis green tea ointment shows as: organo montmorillonite can be as the thixotropic agent of the ointment base for the preparation of Radix Sophorae Flavescentis green tea ointment, thus, the Radix Sophorae Flavescentis green tea ointment thixotropy for preparing is good, medicine high dispersive, stretchability temperature influence are little.
It should be noted that, according to the advantage of the ointment base of the embodiment of the present invention, Radix Sophorae Flavescentis green tea ointment machin its preparation method, be:
1, ointment base of the present invention, the organo montmorillonite that employing prepares through the montorillonite clay of ionic surface active agent modified natural, disperse the thixotropic agent mineral oil gel of formation as the main material of ointment base, therefore there is high thixotropic, medicine high dispersive, feature that stretchability temperature influence is less, solved take lanoline or vaseline etc. as traditional ointment base thixotropy of main component poor, the defect that temperature influence is large, and the ointment medicament release action that adopts this ointment base to prepare is strong, sensitivity to temperature is little, and thixotropy is good.
2, ointment base of the present invention, can regulate the water absorption and the drug release rate that adopt ointment prepared by this ointment base effectively owing to having added the weak emulsifying agent of water suction.The interpolation of the weak emulsifying agent of water suction, can significantly improve the sticking outlet capacity and the water permeability that adopt ointment prepared by this ointment base, accelerate the rate of release of medicine, efficiently solved the poor problem of common oil ointment base release, and increased the washability of medicine.
3, ointment base of the present invention, owing to usining the mixture of isopropyl myristate and Cyclomethicone as lubricant, solve the problem of the lubricity deficiency that has a large amount of liquid paraffin in the ointment that adopts this ointment base to prepare and cause, and reduced the moist sensation of greasy feeling and the agents area of ointment.
4, adopt the ointment of preparing containing the oil ointment base of liquid paraffin of the present invention, there is oil sealing effect, the effective ingredient that can solve in ointment is unstable, easy oxidized problem, and can effectively extend resting period of ointment, the effective ingredient that makes ointment is through depositing of long period and not oxidized, and further, ointment base of the present invention has good prospect in the application aspect of labile drug.
5, Radix Sophorae Flavescentis green tea ointment of the present invention, homogeneous exquisiteness, good, the easy coating of thixotropy, color and luster uniformity, denseness are suitable, nonirritant, drug release effect are strong, better stability of preparation.
6, in the preparation method of Radix Sophorae Flavescentis green tea ointment of the present invention, adopt colloid milling, in colloid mill, carry out wet grinding and disperse the thixotropic agent mineral oil gel preparing, gel rubber system is even, stable; By Radix Sophorae Flavescentis extract and green tea extract fine powder respectively with medicine dispersant, be prepared into after two kinds of medicine dispersion liquids that fully disperse, again with other drug adjuvant stirring and evenly mixing, thus, can effectively prevent Radix Sophorae Flavescentis with the effective ingredient in green tea because directly contacting the stability that affects pharmaceutical preparation, and technique is simple, workable, be applicable to industrialized great production.
Additional aspect of the present invention and advantage in the following description part provide, and part will become obviously from the following description, or recognize by practice of the present invention.
the specific embodiment
Describe embodiments of the invention below in detail.The embodiment the following describes is exemplary, only for explaining the present invention, and can not be interpreted as limitation of the present invention.
Preparation and the quality evaluation of embodiment 1, three kind of prescription Radix Sophorae Flavescentis green tea ointment
According to the Radix Sophorae Flavescentis green tea ointment prescription of listing in table 1, and the corresponding preparation technology that respectively writes out a prescription, prepare respectively three kinds of Radix Sophorae Flavescentis green tea ointment.
Table 1, Radix Sophorae Flavescentis green tea ointment prescription form
Particularly, according to following steps, prepare three kinds of Radix Sophorae Flavescentis green tea ointment:
First, prepare respectively Radix Sophorae Flavescentis extract and green tea extract.
Wherein, Radix Sophorae Flavescentis extract is prepared according to following steps:
10800 grams of Radix Sophorae Flavescentiss, with the decocting in water of 8 times of amounts 3 times, each 1 hour, to obtain Radix Sophorae Flavescentis extractive liquid, then merge extractive liquid, being filtered, was concentrated into by filtrate the concentrated solution that relative density is 1.06～1.08 (50 ℃).Then add hydrochloric acid adjust pH to 3～4, filter, and supernatant is crossed to 732 type cation exchange resin columns, with 30% ethanol of 10 times of resinite hydrops and 6 times of resin volumes, wash away partial impurities, then with 1 times of resin volume strong aqua ammonia alkalization resin, then use 6 times of resin volume 30% ethanol elutions, and by eluent through concentrating under reduced pressure, dry, pulverize, obtain 300 grams of Radix Sophorae Flavescentis extract fine powders, standby.
Green tea extract is prepared according to following steps are rapid:
2000 grams of green tea, add 60% alcohol heating reflux of 10 times of amounts to extract twice, each 1.5 hours, so that acquisition green tea extractive liquor, then merge extractive liquid, by its filtration, filtrate decompression is reclaimed and removes ethanol, then carry out centrifugal, discard residue, D101 type macroporous resin column on filtrate, wash with water to without alcohol taste, then, water elution with 6 column volumes, use again 15% ethanol elution remove impurity of 5 column volumes, finally use 70% ethanol elution of 5 column volumes, and will be partially recycled through ethanol elution, dry, obtain 200 grams of green tea extract fine powders, standby.
Then, according to Radix Sophorae Flavescentis green tea ointment prescription in table 1, according to following preparation technology, the Radix Sophorae Flavescentis extract of above-mentioned acquisition and green tea extract are prepared as respectively to three kinds of Radix Sophorae Flavescentis green tea ointment:
The preparation technology of comparative example: prepare comparative example Radix Sophorae Flavescentis green tea ointment referring to the Radix Sophorae Flavescentis green tea ointment preparation method described in CN1239669A, by reference, it is incorporated to herein in full.
The preparation technology of experimental example 1 and experimental example 2: Polyethylene Glycol-300 of Radix Sophorae Flavescentis extract fine powder and half recipe quantity are at room temperature ground 5 minutes, until grind evenly, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Polyethylene Glycol-300 of green tea extract fine powder and half recipe quantity are at room temperature ground 5 minutes, until grind evenly, obtain green tea extract medicine dispersion liquid.Then, Organic Montmorillonitewith Sodium Laurylsulfonate is dissolved in liquid paraffin, being placed in colloid mill wet grinding disperses 5 minutes, after fully disperseing, add glycerol to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 65 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, add again the isopropyl myristate that is preheated to 65 degrees Celsius, Cyclomethicone and stearyl alcohol, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, to obtain Radix Sophorae Flavescentis green tea ointment (prescription B or C Radix Sophorae Flavescentis green tea ointment).
Thus, obtain the Radix Sophorae Flavescentis green tea ointment of comparative example, experimental example 1 and experimental example 2.
Radix Sophorae Flavescentis green tea ointment to three kinds of prescriptions that obtain carries out outward appearance observation, and result shows that three kinds of prescriptions all can obtain uniform and smooth, the Radix Sophorae Flavescentis green tea ointment that color and luster is bright, and ointment denseness and viscosity at normal temperatures all meets the requirements.
Then, by following experiment, the Radix Sophorae Flavescentis green tea ointment of comparative example, experimental example 1 and experimental example 2 is carried out to quality evaluation and comparison:
1. stability test
(1) cold-resistant heat resistant test
Cold-resistant experiment: three kinds of prescription Radix Sophorae Flavescentis green tea ointment of above-mentioned acquisition are respectively charged in airtight sealed bottle, sealed bottle is filled up in requirement, then sealed bottle is placed in to constant incubator (40 ℃ ± 1 ℃), after 10d, observe and record ointment color and luster, become sour, the character such as foreign odor, layering and quality, the results are shown in following table 2.
Heat resistant test: three kinds of prescription Radix Sophorae Flavescentis green tea ointment of above-mentioned acquisition are respectively charged in airtight sealed bottle, sealed bottle is filled up in requirement, then sealed bottle is placed in to refrigerator (18 ℃ ± 1 ℃), after 10d, observe and record ointment color and luster, become sour, the character such as foreign odor, layering and quality, the results are shown in following table 2.
Table 2, three kinds of prescription Radix Sophorae Flavescentis green tea ointment are placed the character comparative result after 10d under high temperature and low temperature
As can be seen from Table 2, after K cryogenic treatment 10d, becoming sour does not all appear in 3 kinds of prescription Radix Sophorae Flavescentis green tea ointment, the phenomenon of foreign odor and drug matrices layering, but comparative example Radix Sophorae Flavescentis green tea ointment (in this article sometimes also referred to as comparative example ointment) shows difference with color and luster and the quality of experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment (in this article sometimes also referred to as experimental example 1 and 2 ointment), the color and luster of experimental example 1 and 2 ointment and fine texture, and the glossiness of comparative example ointment is in a slight decrease, and there is the slightly phenomenon of hardening of quality, this may be at low temperatures can hardening relevant with vaseline in comparative example ointment and lanoline, and experimental example 1 and 2 ointment adopt organo montmorillonite to disperse the liquid paraffin gel forming as ointment base, temperature influence is less, still can keep at low temperatures and character consistent under room temperature.After high-temperature process 10d, all characteristic indexs of experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment are all without abnormal, though and becoming sour does not appear in comparative example Radix Sophorae Flavescentis green tea ointment, the phenomenon of foreign odor and drug matrices layering, its glossiness declines, and quality becomes partially soft partially rare character.Thus, experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment according to method of the present invention, prepared are described, cold-resistant thermostability is better than comparative example Radix Sophorae Flavescentis green tea ointment.
(2) centrifugal test
Three kinds of above-mentioned acquisition prescription Radix Sophorae Flavescentis green tea ointment are placed in respectively to different centrifuge tubes, equal centrifugal 20min under different rotating speeds then, then take out the lamination of observing ointment, the results are shown in Table 3.Wherein, the amount of the Radix Sophorae Flavescentis green tea ointment in each centrifuge tube is 10g.
The centrifugal test result of table 3, three kinds of prescription Radix Sophorae Flavescentis green tea ointment
As shown in Table 3, three kinds of prescription Radix Sophorae Flavescentis green tea ointment is at≤4000rmin
-1rotating speed under after centrifugal 20min, all there is not the phenomenon of medicine and substrate layering, in stable condition; And at 5000rmin
-1rotating speed under after centrifugal 20min, prescription B, C Radix Sophorae Flavescentis green tea ointment are in stable condition, do not occur drug matrices lamination, but obvious layering occur prescription A Radix Sophorae Flavescentis green tea ointment.Thus, experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment according to method of the present invention, prepared are described, stability is better than comparative example Radix Sophorae Flavescentis green tea ointment.
2. rheology test
(1) utilize the rotary viscosimeter (rotating cylinder of the rotating cylinder factor * 10,25 ℃ ± 1 ℃ constant temperature), measure and be recorded in initial viscosity in viscometer test barrel of three kinds of prescription Radix Sophorae Flavescentis green tea ointment (preparing) of placing under condition of different temperatures after 3h and the viscosity after rotation 30s above, then the ratio of viscosity after calculating respectively the initial viscosity of each ointment and rotating 30s, be denoted as thixotroping value, the results are shown in following table 4.
The rheological property measurement result of table 4, three kinds of prescription Radix Sophorae Flavescentis green tea ointment
As shown in Table 4, under normal temperature condition, (25 ℃) are placed after 3h, the initial viscosity of three kinds of prescription Radix Sophorae Flavescentis green tea ointment is more approaching, when ointment is rotated after 30s in viscometer test barrel, after being subject to shear action 30s, the viscosity of three kinds of prescription Radix Sophorae Flavescentis green tea ointment all has decline in various degree, compared to comparative example ointment, the viscosity degradation of experimental example 1 and 2 ointment is remarkable, present stronger thixotropy, coating also has good improvement, the gain effect that this has adopted liquid paraffin gel that organo montmorillonite disperses to bring as the main material of ointment base just because of these two kinds ointment that adopt Radix Sophorae Flavescentis green tea ointment formula preparations of the present invention.At 0 ℃, place after 3h, compare with under normal temperature condition, the initial viscosity of experimental example 1 and 2 ointment is subject to the impact of temperature little than comparative example ointment, viscosity number after viscosity number after 30s shears and the experimental example under normal temperature condition 1 and 2 ointment are sheared approaches, and after comparative example ointment deposits at 0 ℃, viscosity increases greatly, and after shearing, surrender property is little, still shows larger viscosity number.Equally, at 40 ℃, place the ointment after 3h, viscosity temperature influence degree aspect, experimental example 1 and 2 ointment are better than comparative example ointment, are embodied in comparative example ointment excessively rare, are unfavorable for local use.Thus, experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment according to method of the present invention, prepared are described, thixotropy and stability are better than comparative example Radix Sophorae Flavescentis green tea ointment.
(2) adopt single-point rapid test method, the rheology stability of comparative example, experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment is detected.In brief, get three kinds of prescription Radix Sophorae Flavescentis green tea ointment appropriate, be placed in viscometer, measure respectively its viscosity at 0 ℃, 25 ℃, 30 ℃, 35 ℃, 40 ℃, 45 ℃, then according to Arrhenius chemical kinetics equation
calculate respectively the rheological parameters E of each ointment under different temperatures
ηvalue, the results are shown in following table 5, and wherein η is viscosity, and R is molar gas constant, and T is thermodynamic temperature, and A is pre-exponential factor, by log η, to the relation of 1/T, can obtain slope (E
η/ 2.303R), by slope, can be calculated the rheological parameters E of each ointment under different temperatures
ηvalue.Wherein, in Arrhenius chemical kinetics equation, E
ηfor flow-activation energy, it can reflect the stability of fluid, E
ηbe worth larger, fluid is more stable, thus, when Arrhenius chemical kinetics equation is applied to Researches on Fluids, can illustrate approx the viscosity of fluid and the interdependence of temperature (can be referring to: Ma Xing, etc. the Research on The Rheology of emulsion-type liniment substrate. pharmacy circular, 1988,23 (4): 207-208., is incorporated to it herein in full by reference).In addition, adopting single-point rapid test method to carry out the rheology stability study of ointment, is that mastic viscosity is larger, easily causes larger operate miss, is difficult for recording accurate rheological curve because in rheological property research.
The rheology Stability Determination result of table 5, three kinds of prescription Radix Sophorae Flavescentis green tea ointment
| Radix Sophorae Flavescentis green tea ointment prescription | E η(KJ) |
| Comparative example | 3.46 |
| Experimental example 1 | 4.98 |
| Experimental example 2 | 4.54 |
E by three kinds of prescription Radix Sophorae Flavescentis green tea ointment in table 5
ηvalue can find out in intuitive analysis, and the flow-activation energy of experimental example 1 and 2 ointment is higher than comparative example ointment, due to E
ηbe worth larger, fluid is more stable, result show experimental example 1 and 2 ointment higher than the stability of comparative example ointment, this is consistent with the result that cold-resistant heat resistant test in aforementioned stable test obtains, be that to be embodied in cold-resistant heat resistant test be that character temperature influence is less for experimental example 1 and the higher flow-activation energy of 2 ointment, it is high that stability is wanted, thereby also proved from the flow-activation energy of fluid and infer that its stability has reasonability.Thus, further illustrate experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment according to method of the present invention, prepared, stability is better than comparative example Radix Sophorae Flavescentis green tea ointment.
3. ductility test
The ductility of ointment can directly reflect the whether homogeneous exquisiteness of ointment, easy coating etc., is one of important indicator of ointment quality evaluation.Thus, three of acquisition noted earlier kinds of prescription Radix Sophorae Flavescentis green tea ointment are carried out to ductility research, concrete grammar is as follows: the clean glass plate of getting 2 20cm * 25cm sizes, with marking pen, on glass plate, finish grid, and 2 glass plates are stacked, and make to be positioned at the heavy 125g (deficiency adds counterweight and supplies weight) of glass plate above, then take respectively at 0 ℃, 25 ℃, at 40 ℃, place three kinds of each 1g of prescription Radix Sophorae Flavescentis green tea ointment after 24h, be placed between 2 glass plates that stack, after 1min, with ruler, measure and record the diameter of each ointment after extending, getting maximum and minima and calculate the two meansigma methods (can be referring to: Tu Xide, Deng. pharmaceutics. Beijing: the People's Press, 2001:378., by reference, it is incorporated to herein in full), the results are shown in following table 6.
The ductility experimental result of table 6, three kinds of prescription Radix Sophorae Flavescentis green tea ointment
As shown in Table 6, under 25 ℃ of conditions, the extension diameter range of comparative example, experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment is all between 40-70mm, the stretchability of ointment is better, steady quality, illustrates under normal temperature condition, and 3 kinds of ointment all can provide for the use of medicine good physical effect.Wherein, the ointment of extension diameter≤50mm is called half steel body (Semi-stiff) ointment, the ointment of extension diameter within the scope of 50-70mm is called semifluid (Semi-fluid) ointment, wherein semifluid ointment is considered to comparatively desirable external ointment preparation, and comparative example, experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment under normal temperature condition are substantially all within the scope of this.But through after 0 ℃ and 40 ℃ of processing, there is difference in the ductility of 3 kinds of prescription Radix Sophorae Flavescentis green tea ointment.Comparative example ointment is after low temperature (0 ℃) is processed, and viscosity increases, and the impact that extension diameter is subject to temperature is larger, become half steel body ointment, thereby affected the stretchability of ointment, and after high temperature (40 ℃) is processed, there is rare character, be also unfavorable for the painting exhibition of ointment.And experimental example 1 and 2 ointment, after treatment of different temperature, still remain viscid physical state, extension diameter is in 60mm left and right, and stretchability is good especially.Thus, further illustrate experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment according to method of the present invention, prepared, ductility is better than comparative example Radix Sophorae Flavescentis green tea ointment.
4. medicine releasability test
Radix Sophorae Flavescentis green tea ointment, as the medication for skin, produce therapeutical effect, and first its effective ingredient must be discharged into skin or mucomembranous surface from ointment base, and therefore, the medicine releasability of ointment is also one of important indicator of ointment quality evaluation.
Utilize diffusion cell, respectively three of acquisition noted earlier kinds of prescription Radix Sophorae Flavescentis green tea ointment are carried out to drug release Journal of Sex Research, concrete grammar is as follows:
First, get the microporous filter membrane of 1 μ m, be fixed between the supply pool and acceptance pool of diffusion cell, recirculated water is remained to 37 ℃ ± 0.5 ℃, acceptance pool is usingd 15% ethanol as accepting medium, adds stirrer with the speed stirring of 200r/min, drains bubble, then in Supply House, add 0.5g Radix Sophorae Flavescentis green tea ointment, experiment starts.
Then, while carrying out 1,2,4,6,8h respectively at experiment, take out 1ml acceptable solution (15% ethanol, standby, and immediately to supplementing the acceptable solution (i.e. 15% ethanol) of equivalent equality of temperature in reception tank.
Then, utilize high performance liquid chromatograph, measure respectively the content of the effective ingredient EGCG, matrine and the oxymatrine that discharge from Radix Sophorae Flavescentis green tea ointment in the acceptable solution of each collected time point, and calculate the cumulative release amount of various effective ingredients, the results are shown in following table 7.
The cumulative release amount of the effective ingredient of table 7, three kinds of prescription Radix Sophorae Flavescentis green tea ointment of each time point
Wherein, select 15% alcoholic solution as release medium, to guarantee that release medium is eligible.As shown in Table 7, after permeable membrane is processed, in the acceptable solution of 3 kinds of Radix Sophorae Flavescentis green tea ointment, all corresponding effective ingredient can be detected, and along with the prolongation of experimental period, in acceptable solution, the cumulative release amount of various effective ingredients also increases thereupon.As can be seen from the table, when 8h is carried out in experiment, the EGCG cumulative release amount of experimental example 1 and 2 ointment is respectively 1.85,1.94 times of comparative example ointment, matrine cumulative release amount is respectively 1.98,1.91 times of comparative example ointment, and oxymatrine cumulative release amount is respectively 1.49,1.35 times of comparative example ointment.Thus, further illustrate experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment according to method of the present invention, prepared, medicine releasability is better than comparative example Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 2, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 2700g, green tea 900g, Polyethylene Glycol-300 150g, liquid paraffin 450g, Organic Montmorillonitewith Sodium Laurylsulfonate 40g, glycerol 20g, isopropyl myristate 230g, Cyclomethicone 30g, stearyl alcohol 70g.
(2) method for making:
A. take Radix Sophorae Flavescentis 2700g, with the decocting in water of 8 times of amounts 3 times, each 1 hour.Merge extractive liquid,, being concentrated into relative density is the concentrated solution of 1.06～1.08 (50 ℃).Add hydrochloric acid adjust pH to 3～4, filter, supernatant is crossed 732 type cation exchange resin columns, with 30% ethanol of 10 times of resinite hydrops and 6 times of resin volumes, washes away partial impurities, again with 1 times of resin volume strong aqua ammonia alkalization resin, with 6 times of resin volume 30% ethanol elutions.Eluent, through concentrating under reduced pressure, dry, pulverize, and obtains Radix Sophorae Flavescentis extract fine powder, standby.
B. take green tea 900g, add 60% alcohol heating reflux of 10 times of amounts to extract twice, each 1.5 hours, merge extractive liquid.Extracting solution reclaim under reduced pressure is removed ethanol, and extracting solution is centrifugal, discards residue, D101 type macroporous resin column on filtrate, wash with water to without alcohol taste, with the water elution of 6 column volumes, then use 15% ethanol elution of 5 column volumes, finally use 70% ethanol elution of 5 column volumes, will be partially recycled through ethanol elution, dry, pulverize, obtain green tea extract fine powder, standby.
C. above-mentioned Radix Sophorae Flavescentis extract fine powder and 75g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 75g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 40g and be dissolved in liquid paraffin 450g, being placed in colloid mill wet grinding disperses 8 minutes, after fully disperseing, add glycerol 20g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 60 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, add again the isopropyl myristate 230g that is preheated to 60 degrees Celsius, Cyclomethicone 30g and stearyl alcohol 70g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 3, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 2450g, green tea 860g, polypropylene glycol-500 130g, liquid paraffin 480g, Organic Montmorillonitewith Sodium Laurylsulfonate 50g, glycerol 25g, isopropyl myristate 200g, Cyclomethicone 30g, stearyl alcohol 55g.
(2) method for making:
A. according to recipe quantity, according to the method described in embodiment 2, prepare respectively Radix Sophorae Flavescentis extract and green tea extract, standby.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 65g polypropylene glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 65g polypropylene glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 50g and be dissolved in liquid paraffin 480g, being placed in colloid mill wet grinding disperses 5 minutes, after fully disperseing, add glycerol 25g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 70 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 200g that is preheated to 55 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 55g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 4, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 2500g, green tea 1000g, Polyethylene Glycol-300 200g, liquid paraffin 400g, hexadecyltrimethylammonium chloride modified montmorillonoid 60g, ethanol 30g, n-butyl stearate 270g, Cyclomethicone 30g, stearyl alcohol 50g.
(2) method for making:
A. according to recipe quantity, according to the method described in embodiment 2, prepare respectively Radix Sophorae Flavescentis extract and green tea extract, standby.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 100g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 100g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take hexadecyltrimethylammonium chloride modified montmorillonoid 60g and be dissolved in liquid paraffin 400g, being placed in colloid mill wet grinding disperses 8 minutes, after fully disperseing, add ethanol 30g to continue to disperse 3 minutes, obtain hexadecyltrimethylammonium chloride modified montmorillonoid and disperse the liquid paraffin gel forming, be heated to 65 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the n-butyl stearate 270g that is preheated to 65 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 50g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 5, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 1500g, green tea 500g, polypropylene glycol-500 100g, liquid paraffin 600g, Organic Montmorillonitewith Sodium Laurylsulfonate 30g, glycerol 10g, isopropyl myristate 170g, Cyclomethicone 30g, stearyl alcohol 100g.
(2) method for making:
A. according to recipe quantity, according to the method described in embodiment 2, prepare respectively Radix Sophorae Flavescentis extract and green tea extract, standby.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 50g polypropylene glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 50g polypropylene glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 30g and be dissolved in liquid paraffin 600g, being placed in colloid mill wet grinding disperses 10 minutes, after fully disperseing, add glycerol 10g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 63 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 170g that is preheated to 58 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 100g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 6, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 3000g, green tea 1000g, Polyethylene Glycol-300 160g, liquid paraffin 450g, Organic Montmorillonitewith Sodium Laurylsulfonate 20g, glycerol 15g, isopropyl myristate 240g, Cyclomethicone 30g, stearyl alcohol 80g.
(2) method for making:
A. according to recipe quantity, according to the method described in embodiment 2, prepare respectively Radix Sophorae Flavescentis extract and green tea extract, standby.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 80g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 80g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 20g and be dissolved in liquid paraffin 450g, being placed in colloid mill wet grinding disperses 6 minutes, after fully disperseing, add glycerol 15g to continue to disperse 4 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 66 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 240g that is preheated to 60 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 80g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 7, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 76g (according to the method preparation of preparing Radix Sophorae Flavescentis extract described in embodiment 2), green tea extract 90g (according to the method preparation of preparing green tea extract described in embodiment 2), polypropylene glycol-500 180g, liquid paraffin 500g, Organic Montmorillonitewith Sodium Laurylsulfonate 40g, glycerol 20g, isopropyl myristate 180g, Cyclomethicone 50g, stearyl alcohol 70g.
(2) method for making:
76g Radix Sophorae Flavescentis extract and 90g polypropylene glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; 90g green tea extract and 90g polypropylene glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 40g and be dissolved in liquid paraffin 500g, being placed in colloid mill wet grinding disperses 10 minutes, after fully disperseing, add glycerol 20g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 65 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 180g that is preheated to 65 degrees Celsius, Cyclomethicone 50g, stearyl alcohol 70g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 8, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 70g (according to the method preparation of preparing Radix Sophorae Flavescentis extract described in embodiment 2), green tea extract 86g (according to the method preparation of preparing green tea extract described in embodiment 2), Polyethylene Glycol-300 140g, liquid paraffin 450g, Organic Montmorillonitewith Sodium Laurylsulfonate 50g, glycerol 25g, isopropyl myristate 200g, Cyclomethicone 30g, stearyl alcohol 55g.
(2) method for making:
70g Radix Sophorae Flavescentis extract and 70g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; 86g green tea extract and 70g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 50g and be dissolved in liquid paraffin 450g, being placed in colloid mill wet grinding disperses 10 minutes, after fully disperseing, add glycerol 25g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 65 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 200g that is preheated to 60 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 55g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 9, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 75g (according to the method preparation of preparing Radix Sophorae Flavescentis extract described in embodiment 2), green tea extract 95g (according to the method preparation of preparing green tea extract described in embodiment 2), Polyethylene Glycol-300 200g, liquid paraffin 400g, hexadecyltrimethylammonium chloride modified montmorillonoid 60g, ethanol 30g, n-butyl stearate 270g, Cyclomethicone 30g, stearyl alcohol 50g.
(2) method for making:
75g Radix Sophorae Flavescentis extract and 100g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; 95g green tea extract and 100g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take hexadecyltrimethylammonium chloride modified montmorillonoid 60g and be dissolved in liquid paraffin 400g, being placed in colloid mill wet grinding disperses 6 minutes, after fully disperseing, add ethanol 30g to continue to disperse 3 minutes, obtain hexadecyltrimethylammonium chloride modified montmorillonoid and disperse the liquid paraffin gel forming, be heated to 65 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the n-butyl stearate 270g that is preheated to 60 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 50g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 10, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 42g (according to the method preparation of preparing Radix Sophorae Flavescentis extract described in embodiment 2), green tea extract 50g (according to the method preparation of preparing green tea extract described in embodiment 2), polypropylene glycol-500 100g, liquid paraffin 600g, Organic Montmorillonitewith Sodium Laurylsulfonate 30g, glycerol 10g, isopropyl myristate 170g, Cyclomethicone 30g, stearyl alcohol 100g.
(2) method for making:
42g Radix Sophorae Flavescentis extract and 50g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; 50g green tea extract and 50g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 30g and be dissolved in liquid paraffin 600g, being placed in colloid mill wet grinding disperses 7 minutes, after fully disperseing, add glycerol 10g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 70 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 170g that is preheated to 60 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 100g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The preparation of embodiment 11, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 84g (according to the method preparation of preparing Radix Sophorae Flavescentis extract described in embodiment 2), green tea extract 100g (according to the method preparation of preparing green tea extract described in embodiment 2), Polyethylene Glycol-300 150g, liquid paraffin 480g, Organic Montmorillonitewith Sodium Laurylsulfonate 20g, glycerol 15g, isopropyl myristate 240g, Cyclomethicone 30g, stearyl alcohol 80g.
(2) method for making:
84g Radix Sophorae Flavescentis extract and 75g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain Radix Sophorae Flavescentis extract medicine dispersion liquid; 100g green tea extract and 75g Polyethylene Glycol-300 are at room temperature ground 5 minutes, obtain green tea extract medicine dispersion liquid.
Take Organic Montmorillonitewith Sodium Laurylsulfonate 20g and be dissolved in liquid paraffin 480g, being placed in colloid mill wet grinding disperses 7 minutes, after fully disperseing, add glycerol 15g to continue to disperse 5 minutes, obtain Organic Montmorillonitewith Sodium Laurylsulfonate and disperse the liquid paraffin gel forming, be heated to 70 degrees Celsius, then slowly add successively wherein Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid, stir on interpolation limit, limit, then add the isopropyl myristate 240g that is preheated to 60 degrees Celsius, Cyclomethicone 30g, stearyl alcohol 80g, limit edged stirs, to be mixed evenly after, stop heating, continue to be stirred to room temperature, obtain Radix Sophorae Flavescentis green tea ointment.
In addition, discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that in prepared Radix Sophorae Flavescentis green tea ointment, contain Radix Sophorae Flavescentis green tea.
The discriminating of embodiment 12, Radix Sophorae Flavescentis green tea ointment
The identification result of Radix Sophorae Flavescentis green tea ointment prepared by above-described embodiment 2-11, obtains through the following steps:
Get each 1g of Radix Sophorae Flavescentis green tea ointment prepared by embodiment 2-11, be placed in respectively 10 tool plug conical flasks, then add respectively 3 of dehydrated alcohol 20ml, strong aqua ammonia (concentration is 25-28%), then tool plug conical flask is carried out to heating in water bath to ointment and melt, then carry out supersound extraction 45 minutes, put to room temperature, filter, filtrate evaporate to dryness, adds chloroform 2ml and dissolves, as need testing solution.Separately get matrine, oxymatrine reference substance, add respectively methanol and make every 1ml containing the solution of 0.1mg, in contrast product solution.Utilize thin layer chromatography to test: to draw each 20 μ l points of above-mentioned solution in the silica gel g thin-layer plate of same 0.4%NaOH, lower floor's solution of chloroform-methanol-strong ammonia solution that the volume ratio of take is 5: 0.6: 0.3 is developing solvent, launch, take out, dry, then spray successively with bismuth potassium iodide test solution and sodium nitrite ethanol test solution.In test sample chromatograph, on its position identical with reference substance chromatograph, should there is the speckle of same color.
Get each 1g of Radix Sophorae Flavescentis green tea ointment prepared by embodiment 2-11, be placed in respectively 10 tool plug conical flasks, after interpolation dehydrated alcohol 20ml, carry out heating in water bath to ointment and melt, then carry out supersound extraction 45 minutes, filter filtrate evaporate to dryness, add chloroform 2ml and dissolve, as need testing solution.Separately getting epigallocatechin gallate (EGCG) reference substance adds methanol and makes every 1ml containing the solution of 0.1mg, in contrast product solution.Utilize thin layer chromatography to test: draw each 20 μ l points of above-mentioned solution on same silica gel G plate, chloroform-methanol-acetic acid that the volume ratio of take is 13: 4: 2.5 is developing solvent, launches, take out, dry, then spray the sulphuric acid ethanol test solution with 10%, at 105 ℃, be heated to clear spot.In test sample chromatograph, on its position identical with reference substance chromatograph, should there is the speckle of same color.
Embodiment 13, the test of Radix Sophorae Flavescentis green tea ointment hypersensitive
1, animal and material
30 of healthy albino guinea-pigs, male and female half and half, body weight 250～300g, is provided by Wuhan University Experimental Animal Center.
Radix Sophorae Flavescentis green tea ointment (according to above-described embodiment 2 preparations), the blank substrate that does not contain medicine is (according to the preparation method of above-described embodiment 2, difference with containing not adding Radix Sophorae Flavescentis green tea medicine in the blank substrate of medicine), the 2.4-dinitrochlorobenzene of 1% concentration.
2, test method
Utilize 6% sodium sulfide by spinal column both sides, the back depilation of 30 healthy albino guinea-pigs, every lateral area is 9 square centimeters, observe 24 hours without after skin irritation reaction, Cavia porcellus is divided into three groups at random, every group 10, male and female half and half, first group to Radix Sophorae Flavescentis green tea ointment 0.2g, second group of blank group given the blank substrate 0.2g that does not contain medicine, the 3rd group of positive controls given the 2.4-dinitrochlorobenzene 0.2ml of 1% concentration, every group all only to the administration of guinea pig back right side, and left side is coated with normal saline as negative control.Every animal sub-cage rearing, and make medicine maintain 6h in administration place.Then, when the 7d of administration for the first time and 14d, in kind respectively repeat once, amount to administration 3 times.14d after last administration excites contact, depilation district, right side, back to all Cavia porcelluss carries out administration, first group is coated with Radix Sophorae Flavescentis green tea ointment 0.2g, blank group is coated with the blank substrate of 0.2g, positive controls is coated with the 2.4-dinitrochlorobenzene 0.2ml of 1% concentration, after administration 6h, remove medicine or the blank substrate of administration place, at once observe administration place and have or not skin allergy, then respectively at again observing skin allergy situation after administration 24h, 48h, 72h, and calculate sensitization incidence rate, and carry out sensitization evaluation.
Wherein anaphylaxis is divided into erythema, edema, systemic anaphylaxis.Sensitization incidence rate calculates as follows: will occur the number of animals of skin erythema, edema or systemic anaphylaxis, divided by animal subject sum, obtain the sensitization incidence rate of each treated animal.Sensitization evaluation criterion is: 1～10% is without sensitization; 11～30% slight sensitizations; 31～60% severe sensitizations; 61～80% height sensitizations; 81～100% extreme sensitizations.
3, result of the test
Sensitization incidence rate and the sensitization evaluation result of each treated animal see the following form 9.
Each treated animal sensitization of table 8 is evaluated
| Group | Sensitization incidence rate (%) | Hypersensitive is evaluated |
| Radix Sophorae Flavescentis green tea ointment group | 0 | Without sensitization |
| Blank matrix group | 0 | Without sensitization |
| Positive controls | 100 | Extreme sensitization |
After administration, all there is the phenomenons such as red and swollen in the animal skin of positive controls, sensitization rate is 100%, and the animal of Radix Sophorae Flavescentis green tea ointment group and blank matrix group all occurs without red swelling of the skin, sensitization rate is 0, show ointment base of the present invention and with the Radix Sophorae Flavescentis green tea ointment of this matrix composition to guinea pig skin without sensitization.
In the description of this description, the description of reference term " embodiment ", " some embodiment ", " example ", " concrete example " or " some examples " etc. means to be contained at least one embodiment of the present invention or example in conjunction with specific features, structure, material or the feature of this embodiment or example description.In this manual, the schematic statement of above-mentioned term is not necessarily referred to identical embodiment or example.And the specific features of description, structure, material or feature can be with suitable mode combinations in any one or more embodiment or example.
Although illustrated and described embodiments of the invention, those having ordinary skill in the art will appreciate that: in the situation that not departing from principle of the present invention and aim, can carry out multiple variation, modification, replacement and modification to these embodiment, scope of the present invention is limited by claim and equivalent thereof.
Claims (39)
1. an ointment base, is characterized in that, described ointment base comprises:
The thixotropic agent of 20-60 weight portion, described thixotropic agent is organo montmorillonite;
The medicine dispersant of 100-200 weight portion, described medicine dispersant is to be selected from least one of Polyethylene Glycol-300 and polypropylene glycol-500;
The mineral oil of 400-600 weight portion, described mineral oil is to be selected from least one of liquid paraffin and soft paraffin;
The polar solvent of 10-30 weight portion, described polar solvent is to be selected from least one of glycerol, propylene glycol and ethanol;
The lubricant of 200-300 weight portion, described lubricant is for being selected from isopropyl myristate, n-butyl stearate, cyclohexyl methyl
At least one of silicone, acetyl monoglyceride and cetostearyl alcohol; And
The weak emulsifying agent of the water suction of 50-100 weight portion, the weak emulsifying agent of described water suction is to be selected from least one of stearyl alcohol and glyceryl monostearate.
2. ointment base according to claim 1, it is characterized in that, described organo montmorillonite is to be selected from least one of Organic Montmorillonitewith Sodium Laurylsulfonate, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid.
3. ointment base according to claim 1, is characterized in that, described organo montmorillonite is for being selected from Organic Montmorillonitewith Sodium Laurylsulfonate and hexadecyltrimethylammonium chloride modified montmorillonoid.
4. ointment base according to claim 1, it is characterized in that, described medicine dispersant is Polyethylene Glycol-300 or polypropylene glycol-500, described mineral oil is liquid paraffin, described polar solvent is glycerol, described lubricant is the mixture of isopropyl myristate and Cyclomethicone, and the weak emulsifying agent of described water suction is stearyl alcohol.
5. a Radix Sophorae Flavescentis green tea ointment, is characterized in that, comprises:
Radix Sophorae Flavescentis or Radix Sophorae Flavescentis extract, described Radix Sophorae Flavescentis extract is the water extract of Radix Sophorae Flavescentis;
Green tea or green tea extract, described green tea extract is the alcohol extract of green tea; And
Ointment base described in claim 1～4 any one.
6. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, described Radix Sophorae Flavescentis extract is prepared through the following steps:
Radix Sophorae Flavescentis is carried out to extracting in water, to obtain Radix Sophorae Flavescentis extractive liquid;
Described Radix Sophorae Flavescentis extractive liquid is concentrated, to obtain Radix Sophorae Flavescentis concentrated solution;
Described Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator; And
The described Radix Sophorae Flavescentis concentrated solution through pH regulator is carried out to purification, to obtain described Radix Sophorae Flavescentis extract.
7. Radix Sophorae Flavescentis green tea ointment according to claim 6, is characterized in that, described Radix Sophorae Flavescentis is carried out to extracting in water, further comprises:
Described Radix Sophorae Flavescentis is carried out to decocting in water 2-4 time with the water of 6-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain described Radix Sophorae Flavescentis extractive liquid.
8. Radix Sophorae Flavescentis green tea ointment according to claim 6, is characterized in that, the relative density of described Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees Celsius is 1.06～1.08.
9. Radix Sophorae Flavescentis green tea ointment according to claim 6, is characterized in that, utilizes hydrochloric acid that described Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator, and wherein, the pH of the described Radix Sophorae Flavescentis concentrated solution through pH regulator is 2-5.
10. Radix Sophorae Flavescentis green tea ointment according to claim 6, is characterized in that, utilizes cation exchange resin to carry out purification to described Radix Sophorae Flavescentis concentrated solution.
11. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, described green tea extract is prepared through the following steps:
Green tea is added to alcohol extraction, to obtain green tea extractive liquor; And
Described green tea extractive liquor is carried out to purification, to obtain described green tea extract.
12. Radix Sophorae Flavescentis green tea ointment according to claim 11, is characterized in that, green tea is added to alcohol extraction and further comprise:
Described green tea is carried out to heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain described green tea extractive liquor.
13. Radix Sophorae Flavescentis green tea ointment according to claim 11, is characterized in that, described green tea extractive liquor is carried out to purification and further comprise:
Described green tea extractive liquor is carried out to reduced pressure treatment, to remove ethanol;
Described green tea extractive liquor is carried out to macroporous resin column processing, to obtain purified green tea extractive liquor.
14. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, according to parts by weight, described Radix Sophorae Flavescentis green tea ointment packets contains:
15. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, according to parts by weight, described Radix Sophorae Flavescentis green tea ointment packets contains:
16. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, according to parts by weight, described Radix Sophorae Flavescentis green tea ointment packets contains:
17. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, according to parts by weight, described Radix Sophorae Flavescentis green tea ointment packets contains:
18. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, according to parts by weight, described Radix Sophorae Flavescentis green tea ointment packets contains:
19. Radix Sophorae Flavescentis green tea ointment according to claim 5, is characterized in that, according to parts by weight, described Radix Sophorae Flavescentis green tea ointment packets contains:
20. 1 kinds of methods of preparing Radix Sophorae Flavescentis green tea ointment, is characterized in that, comprising:
Prepare Radix Sophorae Flavescentis extract, described Radix Sophorae Flavescentis extract is water extract;
Prepare green tea extract, described green tea extract is alcohol extract; And
Right to use requires the ointment base described in 1～4 any one, and described Radix Sophorae Flavescentis extract and described green tea extract are made to described Radix Sophorae Flavescentis green tea ointment.
21. methods according to claim 20, is characterized in that, comprising: the described Radix Sophorae Flavescentis extract of preparing further comprises the following steps:
Radix Sophorae Flavescentis is carried out to extracting in water, to obtain Radix Sophorae Flavescentis extractive liquid;
Described Radix Sophorae Flavescentis extractive liquid is concentrated, to obtain Radix Sophorae Flavescentis concentrated solution;
Described Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator; And
The described Radix Sophorae Flavescentis concentrated solution through pH regulator is carried out to purification, to obtain described Radix Sophorae Flavescentis extract.
22. methods according to claim 21, is characterized in that, described Radix Sophorae Flavescentis are carried out to extracting in water, further comprise:
Described Radix Sophorae Flavescentis is carried out to decocting in water 2-4 time with the water of 6-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain described Radix Sophorae Flavescentis extractive liquid.
23. methods according to claim 21, is characterized in that, the relative density of described Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees Celsius is 1.06～1.08.
24. methods according to claim 21, is characterized in that, utilize hydrochloric acid that described Radix Sophorae Flavescentis concentrated solution is carried out to pH regulator, and wherein, the pH of the described Radix Sophorae Flavescentis concentrated solution through pH regulator is 2-5.
25. methods according to claim 21, is characterized in that, utilize cation exchange resin to carry out purification to described Radix Sophorae Flavescentis concentrated solution.
26. methods according to claim 20, is characterized in that, the described green tea extract of preparing further comprises the following steps:
Green tea is added to alcohol extraction, to obtain green tea extractive liquor; And
Described green tea extractive liquor is carried out to purification, to obtain described green tea extract.
27. methods according to claim 26, is characterized in that, green tea is added to alcohol extraction and further comprise:
Described green tea is carried out to heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, and each 0.5-2 hour, and merge extractive liquid,, to obtain described green tea extractive liquor.
28. methods according to claim 26, is characterized in that, described green tea extractive liquor is carried out to purification and further comprise:
Described green tea extractive liquor is carried out to reduced pressure treatment, to remove ethanol;
Described green tea extractive liquor is carried out to macroporous resin column processing, to obtain purified green tea extractive liquor.
29. methods according to claim 20, is characterized in that, described Radix Sophorae Flavescentis extract and described green tea extract are made to ointment and further comprise:
By described Radix Sophorae Flavescentis extract and described green tea extract respectively with described medicine dispersant, to obtain Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid;
Described thixotropic agent is dissolved in to mineral oil and carries out the first dispersion treatment, to obtain thixotropic agent mineral oil mixture;
In described thixotropic agent mineral oil mixture, add polar solvent and carry out the second dispersion treatment, to obtain thixotropic agent mineral oil gel;
To adding successively emulsifying agent a little less than described Radix Sophorae Flavescentis extract medicine dispersion liquid, described green tea extract medicine dispersion liquid, described lubricant and described water suction in described thixotropic agent mineral oil gel, mix homogeneously, to obtain Radix Sophorae Flavescentis green tea ointment.
30. methods according to claim 29, is characterized in that, described the first and second dispersion treatment be one of at least in colloid mill, to carry out wet grinding dispersion.
31. methods according to claim 29, is characterized in that, in described thixotropic agent mineral oil gel, add before described Radix Sophorae Flavescentis extract medicine dispersion liquid, further comprise described thixotropic agent mineral oil gel is heated.
32. methods according to claim 29, is characterized in that, further comprise the step that a little less than described lubricant and water suction, emulsifying agent carries out preheating.
33. methods according to claim 20, is characterized in that, according to parts by weight, described method adopts:
34. methods according to claim 33, it is characterized in that, adopt Polyethylene Glycol-300 as described medicine dispersant, adopt liquid paraffin as described mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as described thixotropic agent, adopt glycerol as described polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as described lubricant, emulsifying agent a little less than adopting stearyl alcohol as described water suction, and according to parts by weight, the ratio of raw material is:
35. methods according to claim 33, it is characterized in that, adopt polypropylene glycol-500 as described medicine dispersant, adopt liquid paraffin as described mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as described thixotropic agent, adopt glycerol as described polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as described lubricant, emulsifying agent a little less than adopting stearyl alcohol as described water suction, and according to parts by weight, the ratio of raw material is:
36. methods according to claim 33, it is characterized in that, adopt Polyethylene Glycol-300 as described medicine dispersant, adopt liquid paraffin as described mineral oil, adopt hexadecyltrimethylammonium chloride modified montmorillonoid as described thixotropic agent, adopt ethanol as described polar solvent, adopt the mixture of n-butyl stearate and Cyclomethicone as described lubricant, emulsifying agent a little less than adopting stearyl alcohol as described water suction, and according to parts by weight, the ratio of raw material is:
37. methods according to claim 33, it is characterized in that, adopt polypropylene glycol-500 as described medicine dispersant, adopt liquid paraffin as described mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as described thixotropic agent, adopt glycerol as described polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as described lubricant, emulsifying agent a little less than adopting stearyl alcohol as described water suction, and according to parts by weight, the ratio of raw material is:
38. methods according to claim 33, it is characterized in that, adopt Polyethylene Glycol-300 as described medicine dispersant, adopt liquid paraffin as described mineral oil, adopt Organic Montmorillonitewith Sodium Laurylsulfonate as described thixotropic agent, adopt glycerol as described polar solvent, adopt the mixture of isopropyl myristate and Cyclomethicone as described lubricant, emulsifying agent a little less than adopting stearyl alcohol as described water suction, and according to parts by weight, the ratio of raw material is:
39. 1 kinds of Radix Sophorae Flavescentis green tea ointment, is characterized in that, described Radix Sophorae Flavescentis green tea ointment is to be prepared by the method described in claim 20～38 any one.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210088149.0A CN102652730B (en) | 2012-03-29 | 2012-03-29 | Ointment base, kuh-seng and green tea ointment and preparation method of ointment |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210088149.0A CN102652730B (en) | 2012-03-29 | 2012-03-29 | Ointment base, kuh-seng and green tea ointment and preparation method of ointment |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102652730A CN102652730A (en) | 2012-09-05 |
| CN102652730B true CN102652730B (en) | 2014-04-16 |
Family
ID=46728563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210088149.0A Active CN102652730B (en) | 2012-03-29 | 2012-03-29 | Ointment base, kuh-seng and green tea ointment and preparation method of ointment |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102652730B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3435978A4 (en) * | 2016-03-31 | 2019-12-11 | Smartech Topical, Inc. | Delivery system |
| US11872199B2 (en) | 2019-11-06 | 2024-01-16 | Smartech Topical, Inc. | Topical formulations of cyclooxygenase inhibitors and their use |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104965046A (en) * | 2015-07-17 | 2015-10-07 | 江苏天晟药业有限公司 | Quality control method for cosmetics containing traditional Chinese medicinal ingredients |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1239669A (en) * | 1999-03-24 | 1999-12-29 | 中国医学科学院肿瘤医院、肿瘤研究所 | Composition of Radix Sophorae Flavescentis and green tea and its application in treating condyloma |
-
2012
- 2012-03-29 CN CN201210088149.0A patent/CN102652730B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1239669A (en) * | 1999-03-24 | 1999-12-29 | 中国医学科学院肿瘤医院、肿瘤研究所 | Composition of Radix Sophorae Flavescentis and green tea and its application in treating condyloma |
Non-Patent Citations (11)
| Title |
|---|
| 冯桂权.膨润土基质软膏剂的制备研究.《云南民族大学学报（自然科学版）》.2008,第17卷(第4期),337-339. * |
| 十二烷基磺酸钠改性蒙脱土的制备与表征;陈海群 等;《无机化学学报》;20040331;第20卷(第3期);251-255 * |
| 新型有机蒙脱土的制备、结构表征及其分散性;王毅 等;《材料导报》;20060531;第20卷;203-205 * |
| 王毅 等.新型有机蒙脱土的制备、结构表征及其分散性.《材料导报》.2006,第20卷203-205. |
| 甲紫乳膏的研制;邢君芬 等;《中国药学杂志》;19960531;第31卷(第5期);282-284 * |
| 白慧东 等.膨润土的药用状况.《新疆中医药》.2006,第24卷(第2期),75-78. |
| 膨润土在药学中的应用;赵兵 等;《沈阳药科大学学报》;20000930;第17卷(第5期);387-390 * |
| 膨润土的药用状况;白慧东 等;《新疆中医药》;20061231;第24卷(第2期);75-78 * |
| 赵兵 等.膨润土在药学中的应用.《沈阳药科大学学报》.2000,第17卷(第5期),387-390. |
| 邢君芬 等.甲紫乳膏的研制.《中国药学杂志》.1996,第31卷(第5期),282-284. |
| 陈海群 等.十二烷基磺酸钠改性蒙脱土的制备与表征.《无机化学学报》.2004,第20卷(第3期),251-254. |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3435978A4 (en) * | 2016-03-31 | 2019-12-11 | Smartech Topical, Inc. | Delivery system |
| US11872199B2 (en) | 2019-11-06 | 2024-01-16 | Smartech Topical, Inc. | Topical formulations of cyclooxygenase inhibitors and their use |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102652730A (en) | 2012-09-05 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| WO2015156455A1 (en) | Method for purifying and extracting spicules from natural bio-sponge obtained from sponge | |
| CN102652730B (en) | Ointment base, kuh-seng and green tea ointment and preparation method of ointment | |
| CN105168385B (en) | A kind of pharmaceutical composition of anti-bacterial, anti-itching and preparation method thereof | |
| CN101015522A (en) | Cream for treating psoriasis and its preparing process | |
| CN102652778A (en) | Medicinal composition | |
| CN103239586A (en) | Flavored agastache turbidity-dispelling external preparation as well as preparation method and application thereof | |
| CN104491838A (en) | Anti-HPV (human papillomavirus) gel dressing and preparation method thereof | |
| CN103272092A (en) | Huoxiang Zhengqi externally-applied preparation and its preparation method and application | |
| CN100544730C (en) | Magnesium isoglycyrrhetate external preparation and its production and application | |
| CN105412192B (en) | A kind of mugwort leaf anti-mite cream, a kind of extraction method of mugwort leaf volatile oil | |
| CN104435020B (en) | A kind of composition for improving skin quality and application thereof | |
| CN101024066A (en) | Jinsangliyan preparation and preparing method | |
| CN101912357B (en) | Gel paste preparation and preparation method thereof | |
| CN103520470B (en) | Preparation method of Chinese medicine mixture | |
| CN105311328B (en) | A kind of Chinese medicine composition that treating gynaecological imflammation and its application | |
| Li et al. | Study on network cross-linked hydrogel with cationic Bletilla striata polysaccharide/carbopol as a drug delivery system | |
| CN105456528A (en) | Suppository for treating gynecological inflammation and preparation method thereof | |
| CN110123901B (en) | Preparation method of Sihuang heart-clearing concentrated pills | |
| CN114010589A (en) | A gynecological gel capable of repairing and moisturizing the reproductive system | |
| CN104288158B (en) | Method for preparing skin cleaning liquid containing tanshinone | |
| CN102440962B (en) | Paeonol micro depot carrier and method for enhancing oxidation resistance of paeonol | |
| CN102309538A (en) | Compound lumbricus extract, and preparation process and composition thereof | |
| CN106492129A (en) | A kind of preparation method of reducing swelling and alleviating pain Chinese medicine composition | |
| CN106177454A (en) | One treats colpitic gel and preparation method thereof | |
| CN107837246B (en) | A kind of multi-branch fog water kudzu gel ointment, its preparation method and application |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |