[go: up one dir, main page]

CN1544055A - Oil of aromatic turmeric dripping pills and its preparing process - Google Patents

Oil of aromatic turmeric dripping pills and its preparing process Download PDF

Info

Publication number
CN1544055A
CN1544055A CNA2003101151689A CN200310115168A CN1544055A CN 1544055 A CN1544055 A CN 1544055A CN A2003101151689 A CNA2003101151689 A CN A2003101151689A CN 200310115168 A CN200310115168 A CN 200310115168A CN 1544055 A CN1544055 A CN 1544055A
Authority
CN
China
Prior art keywords
oil
substrate
oleum curcumae
condensing agent
pill machine
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.)
Granted
Application number
CNA2003101151689A
Other languages
Chinese (zh)
Other versions
CN100364599C (en
Inventor
曲韵智
张宝文
沈晓光
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Chia Tai Green Continent Pharmaceutical Co Ltd
Original Assignee
Beijing Chia Tai Green Continent Pharmaceutical Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Beijing Chia Tai Green Continent Pharmaceutical Co Ltd filed Critical Beijing Chia Tai Green Continent Pharmaceutical Co Ltd
Priority to CNB2003101151689A priority Critical patent/CN100364599C/en
Publication of CN1544055A publication Critical patent/CN1544055A/en
Application granted granted Critical
Publication of CN100364599C publication Critical patent/CN100364599C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to a medicament for treating various diseases including children's respiratory tract disease, virus pneumonia, virus encephalitis, viral enteritis, mumps, virus hepatitis an and the process for its preparation, i.e. aromatic turmeric oil drop pill and method for making it by using oil of aromatic turmeric as raw material, charging base material such as surface active agent polyethylene glycol, sodium carboxymethylstarch according to a finite proportion, mixing homogeneously, heating the mixture to fusion, stirring homogeneously, placing into special-purpose drop pill machine, dropping into condensation agent at suitable speed.

Description

Drop pills of oil of zedoary turmeric and preparation method thereof
[technical field] the present invention relates to a kind of medicine for the treatment of multiple diseases such as infantile respiratory disease, viral pneumonia, viral encephalitis, viral enteritis, mumps, hepatitis A, herpes simplex keratitis (HSK), chronic cervicitis and preparation method thereof.
[background technology] Oleum Curcumae is the volatile oil that extracts from zingiberaceous plant Rhizoma Curcumae, RADIX CURCUMAE, Guangxi zedoary, and its main component is multiple sesquiterpenoids, contains more than 20 kind of compositions such as curcumenol, curzerenone, curdione, cupreol.Modern study proves that Oleum Curcumae has multiple pharmacological effect and clinical practice widely.
One. the pharmacological action of Oleum Curcumae
1. the external growth to multiple tumor strains such as mice ehrlich ascites cell, L615 leukaemia and ascites hepatoma carcinoma cell of antitumor action aromatic turmeric oil preparation is inhibited;
2. antiinflammatory action temperature Rhizoma Curcumae volatile oil can suppress the various pathogens growth, and 1% Oleum Curcumae has inhibitory action to animal acetic acid peritonitis, and mice local edema, inflammation and rat granuloma are swollen the obvious treatment effect;
3. one of antipathogen effect Oleum Curcumae effective ingredient curcumenol can suppress staphylococcus aureus, beta hemolytic streptococcus, escherichia coli, Bacillus typhi growth in test tube, to influenza virus A1, the directly deactivation of A3 type, RSU there is direct repression, rubella, chickenpox virus are also had inhibitory action;
4. the immune system effect is injected the Oleum Curcumae concentrated solution to mouse peritoneal, and be contrast with the normal saline, experimental group mouse thymus, spleen weight, lymphocyte absolute value, macrophage phagocytic function, lysozyme activity, serum antibody titer, Ea and Eb garland formation rate all are higher than matched group as a result, show that Oleum Curcumae has immunological enhancement [1] to mice.
Two. clinical effectiveness
A large amount of clinical researches prove that Oleum Curcumae all has definite curative effect for multiple diseases such as treatment infantile respiratory disease, viral pneumonia, viral encephalitis, viral enteritis, mumps, hepatitis A, herpes simplex keratitis (HSK), chronic cervicitiss.Now quoting the part clinical research data is illustrated:
1. infantile respiratory disease children's acute respiratory tract infection (ARTI) is most commonly in acute bronchitis, acute pneumonia and pharynx-tonsillitis.Pathogenic microorganism mostly is respiratory syncytial virus, and influenza virus, rhinovirus, rubella virus and rotavirus etc.Pathogenic bacterium are more common in streptococcus, golden yellow staphylococcus, mycoplasma pneumoniae etc.Because most of ARTI are viral, do not recommend to use antibiotic in theory.Even by antibacterial or antibacterial, virus mixed infection, because antibiotic unreasonable use in recent years, Resistant strain is increasing, brings difficulty to clinical treatment.
Oleum Curcumae has direct deactivation to respiratory syncytial virus (RBV), and influenza virus A1, A3 type and rotavirus etc. are had deactivation; Most of antibacterial such as golden Portugal bacterium, the streptococcus etc. that cause respiratory tract infection all there is stronger inhibitory action.Oleum Curcumae is evident in efficacy to infantile respiratory tract infection, reaches 94 05%, and the infant to malnutrition, resistance difference has obvious curative effects especially.Disclose outside the effective antiviral of Oleum Curcumae decapacitation, advantages such as also having safe ready, have no drug resistance, untoward reaction is few is applicable to Penicillin antibiotics allergy or nonresponder [1,2].
2. viral pneumonia is in recent years because the extensive use of antibiotics, and bacterial pneumonia reduces relatively, and viral pneumonia has and increases trend year by year, and particularly infantile pneumonia below 3 years old is seen with viral infection more, also is one of infant major causes of death in period.The commonly encountered diseases substance has adenovirus, respiratory syncytial virus and influenza virus.The glucose Oleum Curcumae injection is to add the formulated transfusion type injection of glucose by the volatilization composition that the Chinese medicine Rhizoma Curcumae extracts, and is the Chinese medicine antiviral agents.Its active ingredient---curcumenol has direct deactivation to respiratory syncytial virus and influenza virus A 1 type and A3 type, and the virus of invading cell is had inhibitory action.This paper 84 routine therapeutic effect show that from fever time, cough with asthma disappearance, moist rale disappearance and average hospital days relatively, the treatment group significantly is better than matched group, does not see serious toxicity in the therapeutic process.So the author thinks that the glucose Oleum Curcumae injection has the good curing effect to the infant viral pneumonia, [3] are worthy to be popularized.
3. the viral encephalitis acute viral encephalitis has viral infection and causes meninges and cerebral tissue hyperemia, edema, a series of clinical manifestations of initiation: heating, headache, vomiting, spirit change etc.Oleum Curcumae has inhibition and deactivation to multiple virus, improves body's immunological function.This medicine intravenous drip can blood circulation promoting and blood stasis dispelling, microcirculation improvement, dredge blood flow, accelerate the drainage of toxin, alleviate poisoning symptom, and very strong antioxidant radical effect is arranged, reduce histologic lesion, mind tranquilizing and the heart calming, be used for the treatment of acute viral encephalitis, aspect the improving of clinical symptoms and sign, obviously be better than virazole, have easy to use, bring down a fever fast, poisoning symptom is improved rapidly, shorten characteristics [4] such as the course of disease.
4. viral enteritis infant viral enteritis is usual diseases of childhood and frequently-occurring disease.Many case histories are not good through multiple medication effect.Recent study proves that Oleum Curcumae has antivirus action, can improve the intestinal microcirculation, promotes the damaged epithelial cell regeneration of mucous membrane of small intestine, accelerates the intestinal mucosa reparation, plays anti-diarrhea effect.Zedoary turmeric oil glucose injection also help simultaneously the suffering from diarrhoea correction [5] of infant dehydration.
Cooperate dietetic therapy treatment infantile autumn diarrhea 61 examples with Oleum Curcumae, total effective rate is 95.1%, with the virazole matched group utmost point significant difference (P＜0.01) is arranged, and average course of treatment shortens [1].
5. mumps treatment mumps 128 examples are divided into 2 groups at random, 72 example the Zedoary turmeric oil glucose injection intravenous injections, matched group ribavirin injection of treatment group.The result shows: with Oleum Curcumae treatment children's mumps, fever time shortens, and the parotid gland and submaxillary gland begin the detumescence time and the time of subsiding a swelling fully all shortens, and with the ribavirin matched group significant difference (P＜0.01) are arranged relatively.Other has report, and ranitidine closes Oleum Curcumae treatment mumps, and effect is remarkable, can suppress or the deactivation mumps virus, and enhancing immunity improves symptom, shortens the course of disease, and side effect little [1].
6. hepatitis A is treated children's's hepatitis A.The treatment group gives Zedoary turmeric oil glucose injection, and the matched group mixture of energizing is all obeyed the yellow oral liquid of Cape jasmine for two groups, the cure rate of treatment group as a result 95%, the treatment of control group rate 86% that heals, is detested doing well,improvings such as oil, poor appetite at treatment group yellowish body, yellowish urine, obviously be better than matched group, significant difference [1] is arranged.
7. hepatocarcinoma, colorectal cancer is according to people's such as Chen Chunyong research article introduction, and that Oleum Curcumae has is anticancer, regulate characteristics such as immunity, low toxicity and oiliness.Adopt Chinese medicine preparation Oleum Curcumae trans-hepatic artery perfusion therapy primary hepatocarcinoma, the tumor minification reaches 39.2%.Its curative effect is similar to chemotherapeutic, but its toxicity is obviously little than chemotherapeutic, and the effect [6] that improves liver function is arranged.
Research article brave according to another Li Zhi, Deng Xiaojun is introduced, use Rhizoma Curcumae wet goods Chinese medicine preparation by planting the dabbling way of pump, to carrying out zone treatment and conditioning, tentatively demonstrate comparatively satisfied result because a variety of causes can't excise the patient of (especially some advanced rectal cancer).No matter at aspects such as doing well,improving, quality of life, untoward reaction and life spans all than being excellent through planting the capable regional perfusion group of pump with the conventional chemotherapy medicine, this shows that to treat unresectable advanced CRC be effectively [7] through planting pump perfusion Rhizoma Curcumae wet goods Chinese medicine preparation.
There are many research articles also to introduce the use Oleum Curcumae in addition and treat effective various disease conditions, for example: diseases [1,8,9,10] such as herpes simplex keratitis (HSK), chronic cervicitis, viral rubella, Hand-Food-Mouth Disease and exogenous high fever disease.
Three. the problem of existence
The Oleum Curcumae injection that utilizes prior art to obtain often adopts the administering mode that instils clinically, though there is bioavailability higher, onset and the fast advantage of absorption easily cause allergic reaction or untoward reaction, thereby also directly affects the effect of treatment.It is as follows now to quote the relevant report of part:
1. my institute of Wu's gold leaf vein in 3～August of calendar year 2001 input Oleum Curcumae 540 examples time take place to feel sick, vomiting, erythra 12 examples.The respiratory tract infection that Oleum Curcumae causes virus has curative effect preferably, and clinical practice is wider, though adverse reaction rate is lower, also should cause enough attention [11].
2. grandson passes and to spend on April 14th, 2002 we run into the intravenous drip Oleum Curcumae and cause anaphylaxis 1 example.Because of there being individual variation, any medication all may cause untoward reaction, and abnormal sensory is the signal the earliest [12] that reacts.
3. Chen Yin sesame, the Li Min infant, the man, 4 years old, AD was a viral pneumonia.Infusion treatment (about 50m1) after finds after quiet half an hour that with (lot number 2002070601-02-03) Oleum Curcumae (benefit is the Zhu all) injection 250ml dyspnea, dysphoria, rapid breathing, dripping sweat, the visible urticaria in whole body many places appear suddenly in infant.Health check-up: 40 times/min of heart rate, blood pressure does not detect, and stops transfusion immediately, quiet notes dexamethasone 5mg, behind the subcutaneous injection epinephrine 0.5mg, symptom is alleviated [13] gradually.
It is big that the while injection in use also exists operation easier, and the patient suffering is also big, makes and medical treatment cost high the shortcoming that patient economy burden is heavy.Therefore, be necessary to seek better Oleum Curcumae dosage form to satisfy clinical treatment needs.
[summary of the invention] purpose of the present invention is to remedy the deficiencies in the prior art, provides a kind of bioavailability height to extensive patients and medical personnel, release fast, quick produce effects, toxic and side effects is littler, and uses drop pills of oil of zedoary turmeric easy to carry and preparation method thereof.
With the Oleum Curcumae is primary raw material, according to certain ratio, adds substrate such as surfactant polyethylene, carboxymethyl starch sodium, is prepared from through specific technology, apparatus processing again.
Can obtain drop pills of oil of zedoary turmeric involved in the present invention by following technical process:
One. prescription
Oleum Curcumae---English name Zedoary Turmeric Oil, Chinese phonetic alphabet Ezhuyou;
Substrate---Polyethylene Glycol 1500～20000, in the material such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, tween, carboxymethyl starch sodium any one or a few mix mutually;
The ratio of Oleum Curcumae and substrate counts 1 by weight: (1～9).
Two. preparation technology
According to certain mixed, substrate can be selected Polyethylene Glycol for use to the first step with Oleum Curcumae and substrate 1500～20000, any one or several mixing wherein in the materials such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, tween, carboxymethyl starch sodium use;
Second step placed above mixture heats in the heating container while stirring until fusion;
The 3rd step was adopted special-purpose drop pill machine (as the DW-35 type drop pill machine of Taixing, Jiangsu second pharmaceutical machine factory production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature of drop pill machine remain on (50～100) ℃, and the thermograde that makes condensing agent in the condensation column is (40～10) ℃ for (40～10) ℃ → (5～15) ℃-be condensed fluid upper temp, and bottom temp is (5～-15) ℃;
The 4th step treated that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and was in for the 3rd step during desired state of temperature, and fused material is splashed in the condensing agent with suitable speed by the water dropper of drop pill machine.Condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
The drop pill that the 5th step will be shunk molding by the outlet of drop pill machine takes out, and removes the condensing agent on surface, is drying to obtain.
[beneficial effect] Oleum Curcumae relates to treat a kind of medicine of multiple diseases such as infantile respiratory disease, viral pneumonia, viral encephalitis, viral enteritis, mumps, hepatitis A, herpes simplex keratitis (HSK), chronic cervicitis, be the volatile oil that from zingiberaceous plant Rhizoma Curcumae, RADIX CURCUMAE, Guangxi zedoary, extracts, its main component is multiple sesquiterpenoids, contains more than 20 kind of compositions such as curcumenol, curzerenone, curdione, cupreol.Modern study proves that Oleum Curcumae has multiple pharmacological effect and clinical practice widely.
The Oleum Curcumae injection that utilizes prior art to obtain often adopts the administering mode that instils clinically, though there is bioavailability higher, onset and the fast advantage of absorption easily cause allergic reaction or untoward reaction, thereby also directly affects the effect of treatment.
It is big that the while injection in use also exists operation easier, and the patient suffering is also big, makes and medical treatment cost high the shortcoming that patient economy burden is heavy.
Drop pills of oil of zedoary turmeric involved in the present invention; utilize substrate such as surfactant polyethylene, carboxymethyl starch sodium to mix with the Oleum Curcumae crude drug; be aided with solubilizing agents such as tween again; be refined into solid dispersion, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with the injection that utilizes prior art to obtain, have following beneficial effect:
1. avoided medicine and solvent thereof and adjuvant directly to enter sanguimotor process, can reduce acute toxic and side effects effectively and take place, safe in utilization, effect is lasting, applied range;
2. this dropping pill formulation volume is little, in light weight, more is applicable to and carries.After containing entrance cavity, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum;
3. the contained drug dose of each drop pill of this preparation is accurate, and the patient who is suitable for various disease, the different state of an illness, all ages and classes more flexibly and accurately grasps dosage, is not only applicable to clinically, also can make things convenient for, safety be used for family;
4. production technology, the equipment of preparation drop pills of oil of zedoary turmeric are simple, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust, helps labor protection and environmental protection yet.The preparation drop pill need adopt high-tech means and equipment, and main medicine is uniformly dispersed in substrate, and dosage is accurate, and the ball method of double differences is different little than tablet, and production cost is lower than with the kind tablet more than 50%;
5. drop pills of oil of zedoary turmeric is by after solid drugs and substrate heating, being melt into liquid state, splash into and make in the not miscible condensed fluid, therefore, the stability of drug height, not facile hydrolysis, oxidation, and operation is to carry out under liquid state, no dust pollution, be not subject to the influence of crystal formation, thereby guaranteed the quality of medicine, increased stability.
In sum, make drop pills of oil of zedoary turmeric involved in the present invention have the advantage of triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
The drop pills of oil of zedoary turmeric that [specific embodiment] is involved in the present invention, a concrete example of implementing is as follows:
One. prescription
Oleum Curcumae in this example adopts the product of the wide bright natural pigment company limited in Henan, and the ratio of Oleum Curcumae and substrate is 1: 4; This example mesostroma is selected Tween 80, Polyethylene Glycol for use 20000Mix use for three kinds with carboxymethyl starch sodium, wherein: Tween 80 is 8%, and carboxymethyl starch sodium is 8.4%, Polyethylene Glycol 20000Be 83.6%.
Two. preparation technology
The first step is mixed Tween 80 Oleum Curcumae and is stirred earlier and obtains mixed liquor, again with carboxymethyl starch sodium and Polyethylene Glycol 20000Add mixed liquor and stir standby;
Second step placed above mixture in the heating container, heated while stirring until fusion;
The 3rd step was adopted homemade drop pill machine, adjust the temperature control system of drop pill machine, make the water dropper temperature of drop pill machine remain on 75 ℃ (error＜2%), and to make in the condensation column thermograde of condensing agent be 20 ℃ → 0 ℃ (be that the condensation column upper temp is 20 ℃, bottom temp is 0 ℃, error＜5%);
The 4th step temperature for the treatment of dropping-pill machine head and condensation column inner condensat liquid has been stable respectively to be in for the 3rd step during desired state of temperature, and fused material is splashed in the condensing agent with suitable speed by the water dropper of drop pill machine.Condensing agent uses methyl-silicone oil in this example;
The drop pill that the 5th step will be shunk molding by the outlet of drop pill machine takes out, and removes the condensed fluid on surface, is drying to obtain.
Three. result of the test
Example one selects different substrates to carry out the experiment of prescription
Experimental design: carry out the influence of prescription in order to observe Oleum Curcumae and different substrates, respectively with Polyethylene Glycol to product involved in the present invention 6000, Polyethylene Glycol 10000, Polyethylene Glycol 20000Be one-component substrate, again with Polyethylene Glycol 6000+ Tween 80+carboxymethyl starch sodium, Polyethylene Glycol 10000+ Tween 80+carboxymethyl starch sodium, Polyethylene Glycol 20000+ Tween 80+carboxymethyl starch sodium mixes mutually, form different component substrate more than 3 groups, other is all according to the step of stipulating in [specific embodiment], Oleum Curcumae is even with 1: 4 mixed with different substrate, adopt electrically heated mode that each group prepared materials is heated to fusion respectively, utilize homemade drop pill machine, regulate the requirement that its temperature control system makes the 3rd step of preparation technology in satisfied [specific embodiment], with the methyl-silicone oil is condensing agent, the technical process given according to [specific embodiment] is prepared, can obtain the prescription experiment of 6 Oleum Curcumae and different substrates, and obtain 6 groups of different experimental results and see attached list one.
The experiment of example two Oleum Curcumae and the different proportionings of substrate
Experimental design: carry out the influence of prescription with different many components substrate to product involved in the present invention in order to observe Oleum Curcumae, respectively with 1: 1/1: 2/1: 3/1: 4/1: 5/1: 6/1: 7/1: 8/1: 9 with Oleum Curcumae and substrate difference mix homogeneously, all according to defined terms and step in [specific embodiment], substrate is selected Tween 80, Polyethylene Glycol for use for other 20000Mix use for three kinds with carboxymethyl starch sodium, wherein: Tween 80 is 8%, and carboxymethyl starch sodium is 8.4%, Polyethylene Glycol 20000Be 83.6%.Adopt electrically heated mode that each group prepared materials is heated to fusion respectively, utilize homemade drop pill machine, regulate the requirement that its temperature control system makes the 3rd step of preparation technology in satisfied [specific embodiment], with the methyl-silicone oil is condensing agent, the technical process given according to [specific embodiment] is prepared, can obtain the prescription experiment of 9 Oleum Curcumae and different substrates, and obtain 9 groups of different experimental results and see attached list two.
Select the experiment of different water dropper temperature in example three preparation process
Experimental design: in order to observe of the influence of the different water dropper temperature of selection in the preparation process, utilize homemade drop pill machine, regulate its temperature control system to product involved in the present invention, make the water dropper temperature remain on 50 ℃ respectively, 60 ℃, 70 ℃, 80 ℃, 90 ℃, 100 ℃, temperature error＜2%, and make condensate temperature satisfy the requirement in the 3rd step of preparation technology in [specific embodiment], all according to defined terms and step in [specific embodiment], substrate is selected Tween 80, Polyethylene Glycol for use for other 20000Mix use for three kinds with carboxymethyl starch sodium, wherein: Tween 80 is 8%, and carboxymethyl starch sodium is 8.4%, Polyethylene Glycol 20000Be 83.6%.Oleum Curcumae and substrate are even with 1: 4 mixed, adopt electrically heated mode that the material that configures is heated to fusion, with the methyl-silicone oil is condensing agent, be prepared respectively according to the given technology in front [specific embodiment], can obtain 6 different experiments, and obtain 6 groups of different experimental datas and see attached list three.
Select the experiment of different condensing agents in example four preparation process
Experimental design: select of the influence of different condensing agents in the preparation process to product involved in the present invention in order to observe, respectively with liquid paraffin, methyl-silicone oil, vegetable oil as condensing agent, all according to defined terms and step in [optimum implementation], substrate is selected Tween 80, Polyethylene Glycol for use for other 20000Mix use for three kinds with carboxymethyl starch sodium, wherein: Tween 80 is 8%, and carboxymethyl starch sodium is 8.4%, Polyethylene Glycol 20000Be 83.6%.Oleum Curcumae and substrate are even with 1: 4 mixed, adopt electrically heated mode that the material that configures is heated to fusion, utilize homemade drop pill machine, regulate the requirement that its temperature control system makes the 3rd step of preparation technology in satisfied [specific embodiment], be prepared respectively according to the given technology in front [specific embodiment] again, can obtain 3 different experiments, and obtain 3 groups of different experimental datas and see attached list four.
Select the experiment of different condensing agent temperature in example five preparation process
Experimental design: select of the influence of different condensing agent temperature in the preparation process to product involved in the present invention in order to observe, regulate the refrigeration control system of drop pill machine, make the thermograde of condensing agent in the condensation column remain on 20 ℃ →-5 ℃ respectively, 30 ℃ →-10 ℃, 40 ℃ →-15 ℃, temperature error＜5%, all according to defined terms and step in [optimum implementation], substrate is selected Tween 80, Polyethylene Glycol for use for other 20000Mix use for three kinds with carboxymethyl starch sodium, wherein: Tween 80 is 8%, and carboxymethyl starch sodium is 8.4%, Polyethylene Glycol 20000Be 83.6%.Oleum Curcumae and substrate are even with 1: 4 mixed, adopt electrically heated mode that the material that configures is heated to fusion, utilize homemade drop pill machine, regulating its temperature control system and make the temperature of dropping-pill machine head satisfy the requirement in the 3rd step of preparation technology in [specific embodiment], is condensing agent with the methyl-silicone oil, is prepared respectively according to the given technology in front [specific embodiment] again, can obtain 3 different experiments, and obtain 3 groups of different experimental datas and see attached list five.
Table one atenolol and the mutually blended experiment of different substrates
The composite substrate title Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Polyethylene Glycol 6000 ????20.0 ????40 ????＜30 ????＞10 ??+
Polyethylene Glycol 10000 ????20.0 ????62 ????＜30 ????＞10 ??+
Polyethylene Glycol 20000 ????20.0 ????69 ????＜30 ????＞10 ??+
Polyethylene Glycol 6000+ Tween 80+carboxymethyl starch sodium ????20.0 ????81 ????＜30 ????＞10 ??++
Polyethylene Glycol 10000+ Tween 80+carboxymethyl starch sodium ????20.0 ????88 ????＜30 ????＜10 ??++
Polyethylene Glycol 20000+ Tween 80+carboxymethyl starch sodium ????20.0 ????96 ????＜30 ????＜10 ??+++
Result by table one can see: in an embodiment, when selecting different substrate or substrate combination, to the rounding rate, the ball method of double differences is different and index influence such as hardness is bigger, and dissolve scattered time limit institute is influenced not obvious.
The experiment of table two atenolol and the different proportionings of substrate
Oleum Curcumae: substrate Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
1∶1 ????50.0 ????51 ????＞30 ????＞10 +
1∶2 ????33.3 ????63 ????＞30 ????＞10 +
1∶3 ????25.0 ????83 ????＜30 ????＜10 +++
1∶4 ????20.0 ????95 ????＜30 ????＜10 +++
1∶5 ????16.7 ????96 ????＜30 ????＜10 +++
1∶6 ????14.3 ????96 ????＜30 ????＜10 +++
1∶7 ????12.5 ????95 ????＜30 ????＜10 +++
1∶8 ????11.1 ????97 ????＜30 ????＜10 +++
1∶9 ????10.0 ????97 ????＜30 ????＜10 +++
Result by table two can see: in an embodiment, when the mixed proportion of raw material and substrate was 1: 4, rounding rate index had reached level preferably, and other index also enters a preferable scope accordingly.
Table three is selected the experiment of different water dropper temperature
The water dropper temperature Effective ingredient (%) The rounding rate Dissolve scattered time limit The ball method of double differences is different Hardness
50℃ ????20 ????50 ????＜30 ????＞10 +
60℃ ????20 ????62 ????＜30 ????＞10 +
70℃ ????20 ????90 ????＜30 ????＜10 +++
80℃ ????20 ????92 ????＜30 ????＜10 +++
90℃ ????20 ????80 ????＜30 ????＜10 ++
100℃ ????20 ????73 ????＜30 ????＞10 +
Result by table three can see: in an embodiment, when selecting different water dropper temperature, to the rounding rate, the ball method of double differences is different and the hardness number influence is bigger, and dissolve scattered time limit is not had obvious influence.
Table four is selected the experiment of different condensing agents
Condensing agent Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
Liquid paraffin ????20 ????75 ????＜30 ????＜10 +++
Methyl-silicone oil ????20 ????96 ????＜30 ????＜10 +++
Vegetable oil ????20 ????71 ????＜30 ????＞10 ++
Result by table four can see: bigger to the influence of rounding rate index when selecting different condensing agents in an embodiment, and with hardness certain influence is arranged to the ball method of double differences is different, and dissolve scattered time limit is not had obvious influence.
Table five is selected the experiment of different condensing agent temperature
The condensing agent temperature Effective ingredient (%) Rounding rate (%) Dissolve scattered time limit (minute) The ball method of double differences different (%) Hardness
20→-5℃ ????20 ????94 ????＜30 ????＜10 +++
30→-10℃ ????20 ????93 ????＜30 ????＜10 ++
40→-15℃ ????20 ????81 ????＞30 ????＞10 ++
Result by table five can see: in an embodiment, when selecting different condensing agent temperature, rounding rate index is had certain influence, and to dissolve scattered time limit, the ball method of double differences is different and index influence such as hardness is less.
(annotate: the hardness method for expressing in the subordinate list, adopt drop pill is placed on the glass plate, press...with one's finger it, observe its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.)
The partial reference data is as follows:
Song go on foot prosperous, Ju Jianfeng. the pharmacological action of Oleum Curcumae and clinical practice. Shandong medical industry 2003,22 (4) is P.32
2. all brocade spring. the observation of curative effect of Oleum Curcumae treatment infantile respiratory disease. department of pediatrics pharmaceutical journal 2003,9 (4) is P.52-54
3. Zhang Zhiqiang. glucose Oleum Curcumae injection treatment infant viral pneumonia 146 routine .Anthology ofMedicine, February 2003, Vol.22, No.1
4. Wu builds quick. Zedoary turmeric oil glucose injection treatment acute viral encephalitis observation of curative effect. and Strait Pharmaceutical Journal 2003,15 (1) is P.49-50
5. Yu laughs at the tinkling of pieces of jade. Oleum Curcumae treatment infant viral enteritis 312 examples. and clinical medicine 2003,12 (3) is P.68
Chen Chun forever, Xu Kai, HEY JUDE is full of, Wu Wanyin, Deng Hong. Oleum Curcumae hepatic arterial infusion embolotherapy secondary liver cancer 28 routine observation of curative effect. the new traditional Chinese medical science 2003,3-35 (3) P.23-24
7. Li Zhi is brave, Deng Xiaojun. and Rhizoma Curcumae wet goods Chinese medicine is through planting the clinical observation of pump regional perfusion treatment advanced CRC. and Chinese combination of Chinese and Western medicine magazine 2003,23 (1) is P.72
8. Wu's fishing China, Fang Jianhua. Oleum Curcumae treatment viral rubella. Chinese basic unit medicine 2002,10-9 (10) is P.959
9. the king cultivates. Oleum Curcumae injection treatment Hand-Food-Mouth Disease observation of curative effect. and Zhejiang combination of Chinese and Western medicine magazine 2003,13 (7) is P.437
10. Li Wei is refined, Chen Chaojun. the clinical observation of Oleum Curcumae treatment exogenous high fever disease .113 example. and Hubei Journal of Traditional Chinese Medicine 2003,25 (6) is P.20
11. Wu's gold leaf, Wang Chengfeng, Huang Jiajun. the untoward reaction of Oleum Curcumae and control .Herald of MedicineVol.21May2002P.122
12. grandson passes flower. Oleum Curcumae causes anaphylaxis 1 example. and Jining Medical College journal 2003,9-26 (3) is P.70
13. the Chen Yin sesame, Li Min. Oleum Curcumae injection causes anaphylactic shock 1 routine .Chin J Pharmcoe pidemiol2003, Vol.12, No.3P.136

Claims (7)

1. drop pills of oil of zedoary turmeric is characterized in that: this drop pill is to be mixed mutually in certain proportion by Oleum Curcumae and selected substrate, forms through specific prepared again.
Prescription:
Oleum Curcumae---English name Zedoary Turmeric Oil, Chinese phonetic alphabet Ezhuyou;
Substrate---Polyethylene Glycol 1500～20000, in the material such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, tween, carboxymethyl starch sodium any one or a few mix mutually;
The ratio of Oleum Curcumae and substrate counts 1 by weight: (1～9).
2. drop pills of oil of zedoary turmeric according to claim 1 is characterized in that: the proportioning of Oleum Curcumae and described substrate more preferred range is 1: 2～6.
3. drop pills of oil of zedoary turmeric according to claim 1 is characterized in that: in the substrate of being addressed, and Polyethylene Glycol more preferably 6000～20000, three kinds of substrate such as tween, carboxymethyl starch sodium mix and use.
4. the preparation method that is used for the described drop pills of oil of zedoary turmeric of claim 1 is characterized in that being made of following step:
According to certain mixed, substrate can be selected Polyethylene Glycol for use to the first step with Oleum Curcumae and substrate 1500～20000, any one or several mixing wherein in the materials such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, tween, carboxymethyl starch sodium use;
Second step placed above mixture heats in the heating container while stirring until fusion;
The 3rd step was adopted special-purpose drop pill machine, and the temperature control system of adjustment drop pill machine, make the water dropper temperature of drop pill machine remain on (50～100) ℃, and the thermograde that makes condensing agent in the condensation column is (40～10) ℃ for (40～10) ℃ → (5～-15) ℃-be condensing agent upper temp, and bottom temp is (5～-15) ℃;
The 4th step treated that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and was in for the 3rd step during desired state of temperature, and fused material is splashed in the condensing agent with suitable speed by the water dropper of drop pill machine.Condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
The drop pill that the 5th step will be shunk molding by the outlet of drop pill machine takes out, and removes the condensing agent on surface, is drying to obtain.
5. according to the step 3 of the described preparation method of claim 5, it is characterized in that: the preferred scope of temperature of dripping dropping-pill machine head in the system process is (60～90) ℃.
6. according to the step 3 of the described preparation method of claim 5, it is characterized in that: the most preferred scope of temperature of dripping dropping-pill machine head in the system process is (70～80) ℃.
7. according to the step 4 of the described preparation method of claim 5, it is characterized in that: the optimum temperature gradation of dripping condensing agent in the system process is (20 →-5) ℃.
CNB2003101151689A 2003-11-25 2003-11-25 Oil of aromatic turmeric dripping pills and its preparing process Expired - Fee Related CN100364599C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CNB2003101151689A CN100364599C (en) 2003-11-25 2003-11-25 Oil of aromatic turmeric dripping pills and its preparing process

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNB2003101151689A CN100364599C (en) 2003-11-25 2003-11-25 Oil of aromatic turmeric dripping pills and its preparing process

Publications (2)

Publication Number Publication Date
CN1544055A true CN1544055A (en) 2004-11-10
CN100364599C CN100364599C (en) 2008-01-30

Family

ID=34337262

Family Applications (1)

Application Number Title Priority Date Filing Date
CNB2003101151689A Expired - Fee Related CN100364599C (en) 2003-11-25 2003-11-25 Oil of aromatic turmeric dripping pills and its preparing process

Country Status (1)

Country Link
CN (1) CN100364599C (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1872318B (en) * 2005-06-01 2010-08-25 天津天士力制药股份有限公司 Drop pills of oil of zedoary turmeric, and preparation method
CN102058573A (en) * 2010-11-30 2011-05-18 浙江省中医院 Application of curcuma wenyujin diterpene compound C in drugs for treating gastrointestinal inflammation
CN103655492A (en) * 2012-09-24 2014-03-26 天津药物研究院 Sofalcone dripping pills and preparation method and application thereof
CN107126417A (en) * 2017-05-12 2017-09-05 辽宁大学 A kind of curcuma zedoary alcohol solid dispersoid and its oral solid formulation
TWI648061B (en) * 2017-12-20 2019-01-21 大仁科技大學 Manufacture method of turmeric dripping pills and turmeric dripping pills thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1552404A (en) * 2003-06-03 2004-12-08 成都和康药业有限责任公司 Medicine against virus

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1872318B (en) * 2005-06-01 2010-08-25 天津天士力制药股份有限公司 Drop pills of oil of zedoary turmeric, and preparation method
CN102058573A (en) * 2010-11-30 2011-05-18 浙江省中医院 Application of curcuma wenyujin diterpene compound C in drugs for treating gastrointestinal inflammation
CN102058573B (en) * 2010-11-30 2012-05-30 浙江省中医院 Application of curcuma wenyujin diterpene compound C in drugs for treating gastrointestinal inflammation
CN103655492A (en) * 2012-09-24 2014-03-26 天津药物研究院 Sofalcone dripping pills and preparation method and application thereof
CN103655492B (en) * 2012-09-24 2016-02-10 天津药物研究院 A kind of sofalcone drop pill and its preparation method and application
CN107126417A (en) * 2017-05-12 2017-09-05 辽宁大学 A kind of curcuma zedoary alcohol solid dispersoid and its oral solid formulation
TWI648061B (en) * 2017-12-20 2019-01-21 大仁科技大學 Manufacture method of turmeric dripping pills and turmeric dripping pills thereof

Also Published As

Publication number Publication date
CN100364599C (en) 2008-01-30

Similar Documents

Publication Publication Date Title
CN102145062A (en) Active extracts of rosa roxburghii tratt fruit, and preparation method, detection method and application thereof
CN1256954C (en) Blumea oil dripping pills and its preparation process
CN1857678A (en) Mastoproliferation treating medicine and its preparing method
CN1544055A (en) Oil of aromatic turmeric dripping pills and its preparing process
CN1864666A (en) Lyophilized powder injection of levofloxacin mesylate and preparation method thereof
CN1634361A (en) Traditional Chinese medicine powder for treating mastitis of dairy cattle
CN1301098C (en) Hairy holly root drip pill and its preparation method
CN1899385A (en) Process for preparing Chinese medicine compound injection for treating chronic renal failure and use
CN1283246C (en) Complex rheum officinale-radix scutellariae extract injecta for treating acute pancreatitis and preparing method thereof
CN1265805C (en) Chinese medicine oral preparation for lonering blood sugar and its preparation method
CN1301100C (en) Nauclea officinalis drip pill and its preparation method
CN1895314A (en) A lyophilized powder for injection containing Notoginseng radix total saponin with good appearance and shatter resistance, and its preparation method
CN102670863A (en) Compound propolis composition for treating acariasis of domestic animal and preparation method thereof
CN1241557C (en) Ambroxol guttate pill and method for preparing the same
CN1301107C (en) Xiyanping drop pills of possessing function of clearing away heat and toxic materia and preparation method
CN1754554A (en) A kind of traditional Chinese medicine composition
CN1183949C (en) Medicine for treating thrombus disease
CN1634452A (en) Yin-nourishing lung-heat clearing drop pills
CN1895458A (en) Compound Chinese-medicinal extract for treating gynaopathy and its preparation
CN1720948A (en) Dripping pills of lllicium henryi dripping pills and method for preparing the same
CN1307984C (en) Cervix cancer drip pill and its preparation method
CN1323656C (en) Medicine for treating rheumatic arthritis and preparation technology of its spray agent
CN1660364A (en) 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method
CN1634255A (en) Compound formulation of breviscapine for treating cardiovascular and cerebrovascular diseases and its preparing process
CN1524571A (en) A medicament and its preparation process

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
C17 Cessation of patent right
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20080130

Termination date: 20091225