CN1853660A - Erigeron breviscapus preparation and making method thereof - Google Patents
Erigeron breviscapus preparation and making method thereof Download PDFInfo
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Abstract
A Chinese medicine in different multiple forms for treating cardiovascular and cerebrovascular diseases, hepatitis, hepatocirrhosis, senile dementia, pneumocardial disease, vertebral or basilar artery ischemia, acute pancreatitis, gastric ulcer, etc is prepared from shortscape fleabane herb through grinding, refluxing in alcohol, filtering, recovering alcohol and shaping.
Description
Technical field: the present invention is a kind of fleabane preparation for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, belongs to Chinese medicine
Technical field.
Technical background: according to modern pharmacological research, Herba Erigerontis blood circulation promoting and blood stasis dispelling, dredge the meridian passage; Function with vasodilator, microcirculation improvement, raising cardiac and cerebral blood-supply flow; The scalable blood fat suppresses platelet and erythrocyte aggregation, and blood viscosity lowering promotes fibrinolytic, improves hemorheological property; But also formation or the release that can remove oxygen-derived free radicals, inhibition histamine medium.A large amount of research has been done to it by many inventors and medicine enterprise, and the product of some treatments also is provided; As the herba asari capsule that has gone on the market, erigeron breviscapus granule, Flebane oral liquid, dosage form falls behind, and product quality is not ideal enough, and the dosage form kind is abundant inadequately, is suitable for crowd's narrow range, and product bioavailability, medicine stability are undesirable; Herba Erigerontis injection, safety, ease of use are relatively poor; And number of patent application to be " 03102405 ", name be called the patent application of " Herba Erigerontis oral cavity quickly disintegrating tablet and preparation method thereof ", the preparation technology of this dosage form is immature, the cost height, many, the consuming time length of step, also needing of having with an organic solvent waited, and produces a series of labor protection and problem of environmental pollution thus; About Breviscapine, breviscapine can not be equal to the drug effect of Herba Erigerontis as the extract of Herba Erigerontis; In view of such circumstances, seek a kind of therapeutic effect ideal, the thing that effective medicine preparation stable and controllable for quality has just become people to be badly in need of solving.
Summary of the invention: the objective of the invention is to: a kind of fleabane preparation for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof is provided; The present invention is directed to prior art, the micropill that provides, dispersible tablet, disintegrative are good, have solved poorly soluble composition bioavailability problem, are particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, adopt packaging technique, helped stable components; Soft capsule provided by the invention, drop pill can be covered poor taste, the abnormal smells from the patient of medicine, and play the effect that increases stability, improves bioavailability; And technical maturity is stable, is beneficial to penetration and promotion.
The present invention constitutes like this: it is the injection of being made by Herba Erigerontis 500～5000g, comprising: all acceptable dosage forms on injection, powder pin, freeze-dried powder, gel, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and the membrane pharmaceutics.Say accurately: described preparation is dispersible tablet, soft capsule, micropill, drop pill, effervescent tablet, gel.Get the Herba Erigerontis medical material, chopping, water or ethanol extraction, extracting solution filters, and the filtrate decolouring is condensed into thick paste, adds the preparation that suitable adjuvant is made needs again.Soft capsule in the described preparation prepares like this: get the Herba Erigerontis medical material, chopping is with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, add an amount of active carbon, boil, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, measure general flavone content according to the method under the assay item and make every to contain total flavones be 45mg, adjust content with starch after, drying under reduced pressure gets extract, extract is pulverized, sieve, add suitable adjuvant, use the colloid mill mix homogeneously, select suitable softgel shell prescription and pressing conditions for use, the compacting soft capsule, dryness finalization, promptly.In w/v, the consumption of active carbon is 2% of a medicinal liquid total amount, and the time that adds the active carbon boiling decoloring is 15 minutes; The order number of Herba Erigerontis extract grinding and sieving is 100 orders.Selected pharmaceutical adjunct is PEG400 and glycerol.The ratio of pharmaceutical adjunct and medical material is: Herba Erigerontis medical material: PEG400: glycerol=2000: 338.4: 26.3.Soft capsule shell prescription ratio is defined as: gelatin 100g, purified water 100g, glycerol 35g, PEG400 5g, Brown Ferric Oxide 0.2g, ethyl hydroxybenzoate 0.2g, propyl hydroxybenzoate 0.2g.Sprinkler body temperature in the soft capsule pressing process should be controlled at 42～46 ℃.The dryness finalization time after the soft capsule compacting is finished is 10 minutes.
Dispersible tablet in the described preparation prepares like this: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, add the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, by medicine: adjuvant is 2: 1 a low-substituted hydroxypropyl cellulose, by medicine: adjuvant is 2: 1 a microcrystalline Cellulose, and mix homogeneously is crossed sieve No. 5, make wetting agent system soft material with the 8%PVP alcoholic solution, cross the sieve series grain No. 2,60 ℃ of oven dry, No. 2 sieve granulate, simultaneously by medicine: adjuvant is a tabletting behind 0.5: 1 the low-substituted hydroxypropyl cellulose mixing, place in the miniature bottom spraying type boiling granule coating machine and carry out coating, coating solution is 5% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 125Lmin
-1, atomization gas pressure 0.25Mpa, coating solution flow 0.5mLmin
-1, 20 ℃ of coating temperature, promptly.
Pellet in the described preparation prepares like this: get Herba Erigerontis; chopping; with 80% alcohol heating reflux 2 times; each 1 hour; alcohol adding amount is respectively 8; 6 times of amounts; filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%; boiled 15 minutes; filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, and by medicine: adjuvant is 5: 3 a microcrystalline Cellulose; press medicine: adjuvant adds 1: 3 lactose; cross the abundant mixing of 60 mesh sieves; adding concentration and be 50% ethanol is that wetting agent is made soft material, adopts and extrudes-round as a ball comminutor, extrudes rotating speed 35rmin
-1,, round as a ball 6min, round as a ball rotating speed 650rmin
-1,, make micropill, in 50 ℃ of bakings 12 hours, take out, place in the miniature bottom spraying type boiling granule coating machine and carry out coating, coating solution is 6% HPMC alcoholic solution, the coating parameter is as follows: air blast flux 120Lmin
-1, atomization gas pressure 0.22Mpa, coating solution flow 0.8mLmin
-1, 30 ℃ of coating temperature, promptly.
Drop pill in the described preparation prepares like this: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts, filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, adds PEG4000: PEG4000=2: in 1 the mixed-matrix, the proportioning of medicine and substrate is 1: 2, splash in the coolant methyl-silicone oil 100, a system condition is as follows: 65 ℃ of melt temperatures, drip 75 ℃ of system temperature, 1～5 ℃ of chilling temperature, drip apart from 10cm, cooling column length 23cm, promptly.
Effervescent tablet in the described preparation prepares like this: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts, filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, dry below 80 ℃, pulverize, get extract powder, add 10% sodium bicarbonate, 10% citric acid, 1.5% aspartame pulverize separately is with the medicated powder mix homogeneously, granulate, drying, tabletting, coating, coating material: internal layer uses PVP to add titanium dioxide, the outer acrylic resin II that uses, during 40 ℃ of sheet bed tempertaures, jet velocity 6.0ml/kgmin, promptly.
Gel in the described preparation prepares like this: get Herba Erigerontis, chopping is with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boils 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, and 1.2% carrageenan is put into cold water, make it to disperse, soak 20～30min, make the abundant water absorption and swelling of substrate, add 10% sucrose, heating adds sodium bicarbonate, transfers pH7.0, agitation and filtration then, filter the back and add the medicine clear paste under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying, promptly.
Compared with prior art, the present invention is directed to prior art, the micropill that provides, dispersible tablet, disintegrative are good, solved poorly soluble composition bioavailability problem, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, adopted packaging technique, help stable components; Soft capsule provided by the invention, drop pill can be covered poor taste, the abnormal smells from the patient of medicine, and play the effect that increases stability, improves bioavailability.The applicant finds in research process, adjuvant, moulding process are most important for the quality of product, the adjuvant of dispersible tablet particularly, coating solution flow in round as a ball time in the pill making craft of micropill, round as a ball rotating speed, the art for coating, coating temperature, the consumption of soft capsule matrix, capsule material etc., drop pill drip in the system process melt temperature molten, drip system temperature etc.; So by a series of experiments, with the supplementary product kind of the preparation technology that selects pharmaceutical preparation provided by the invention, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.Preparation of the present invention can also be treated hepatitis, liver cirrhosis, senile dementia, pulmonary heart disease, vertebro-basilar arterial ischemia, hepatitis, liver cirrhosis, acute pancreatitis, gastric ulcer etc.
Experimental example 1: technical study
(1) dispersible tablet Study on Forming
Dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, it is poor to have solved former dosage form disintegrative, stripping is shortcoming slowly, and the dispersible tablet that the applicant makes is disintegrate fully in the 3min in 19 ℃～21 ℃ water, and suspension ability is good, bioavailability is high, dispersed homogeneous degree.The mensuration of dispersing uniformity: with reference to Chinese Pharmacopoeia version appendix in 2000 IA, get 6 of dispersible tablets, place the jolting of 100ml water, in (20 ± 1) ℃ water, the whole disintegrates of 3min planted agent are also passed through sieve No. 2.
1. adjuvant screening
| Group | Add (medicine: adjuvant) in the low-substituted hydroxypropyl cellulose | Low-substituted hydroxypropyl cellulose adds (medicine: adjuvant) | Microcrystalline Cellulose (medicine: adjuvant) | PVP alcoholic solution concentration % | Dispersing uniformity |
| 1 | 1.5∶1 | 1∶1 | 3∶1 | ?5 | Grain is thicker |
| 2 | 1.5∶1 | - | 3∶1 | ?5 | Grain becomes sticking group |
| 3 | 1.5∶1 | 1∶1 | - | ?5 | Grain is thicker |
| 4 | 2∶1 | 0.5∶1 | 2∶1 | ?8 | Qualified |
| 5 | 2∶1 | - | 2∶1 | ?8 | Grain becomes sticking group |
| 6 | 2∶1 | 0.5∶1 | - | ?8 | Grain is thicker |
The result shows, optimum process condition is by medicine: adjuvant is to add low-substituted hydroxypropyl cellulose, 2: 1 microcrystalline Cellulose at 2: 1, mix homogeneously, cross sieve No. 5, make wetting agent system soft material with the 8%PVP alcoholic solution, cross No. 2 sieve series grains, 60 ℃ of oven dry, No. 2 sieve granulate, simultaneously by medicine: adjuvant is a tabletting behind 0.5: 1 the low-substituted hydroxypropyl cellulose mixing.
2. art for coating
Outward appearance
| Group | 0 month | June | December |
| Plain sheet | Color and luster is inhomogeneous | Color and luster is inhomogeneous | The tide knot, color and luster is inhomogeneous |
| Dispersible tablet of the present invention (Film coated tablets) | Rounding is bright and clean, color and luster is even | Rounding is bright and clean, color and luster is even | Rounding is bright and clean, color and luster is even |
The result shows that product character of the present invention is good.
(2) pellet Study on Forming
Pill making craft: take by weighing the 40g micropill, pour into lightly in the graduated cylinder of 100mL, fall repeatedly from the 5cm eminence then, no longer change up to volume, the recording volume number calculates bulk density.Roundness: the plane critical angle [3] of this measuring micropill, be about to a certain amount of micropill and put on the flat board, a dull and stereotyped side is lifted, to measure at micropill begin the to roll angle (φ) of top rake plane and horizontal plane, this angle is more little, and the roundness of micropill is good more.
| Group | Concentration of alcohol % | Round as a ball time min | Round as a ball rotating speed rmin -1 | Bulk density gmL -1 | Roundness φ |
| 1 | 30 | ?6 | 650 | 0.75 | 14.5 |
| 2 | 30 | ?8 | 700 | 0.72 | 15.0 |
| 3 | 40 | ?6 | 650 | 0.71 | 14.9 |
| 4 | 40 | ?8 | 700 | 0.74 | 15.1 |
| 5 | 50 | ?6 | 650 | 0.80 | 13.4 |
| 6 | 50 | ?8 | 700 | 0.70 | 14.2 |
The result shows, the technology that the present invention prepares micropill is that 50% ethanol is that wetting agent is made soft material for adding concentration, adopts and extrudes-round as a ball comminutor round as a ball 6min, round as a ball rotating speed 650rmin
-1
2. art for coating
Table 1 coating solution flow/mLmin
-1Atomizing effect
0.5 general, a small amount of big droplet is arranged
0.8 good, there is not big droplet
1.2 general, a small amount of big droplet is arranged
1.5 poor, more big droplet is arranged
Table 2 coating temperature/℃ coating effect
20 is general, and many glutinous companies are arranged
25 is better, and micropill has seldom to be measured glutinous the company
30 is good, not glutinous company the between the micropill
35 is better, and micropill has seldom to be measured glutinous the company
Table 3 outward appearance
| Group | 0 month | June | December |
| Coated micropill not | Rounding, even, bright and clean | Rounding, even, bright and clean | Rounding, even, a little damp knot |
| Micropill of the present invention | Rounding, even, bright and clean | Rounding, even, bright and clean | Rounding, even, bright and clean |
The result shows that art for coating is coating solution flow 0.8mLmin
-1, 30 ℃ of product stabilities that make of coating temperature strengthen.
(3) soft capsule technical study
(1) activated carbon dosage is investigated and to be got Herba Erigerontis 100g, chopping, and with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was 8,6 times of amounts, filter, filtrate merges, and gets medicinal liquid, respectively taking liquid 100ml, press table 5 and add active carbon, boiled 15 minutes, filter, filtrate is concentrated into dried.Investigate the medicinal liquid color, measure scutellarin content in the dried cream.
Activated carbon dosage is investigated
| Sample number | Activated carbon dosage (%) | The medicinal liquid color | Scutellarin content (mg/g crude drug) |
| 1 | 0 | ++++ | 2.20 |
| 2 | 1 | +++ | 2.16 |
| 3 | 2 | ++ | 2.14 |
| 4 | 3 | ++ | 2.08 |
Annotate: "+" expression medicinal liquid shade degree, "+" is many more, and the medicinal liquid color is dark more.
Above-mentioned test shows that activated carbon dosage is good with 2%, and this moment, the medicinal liquid color was more shallow, and scutellarin content descends less.
(2) moulding process
1. the diluent that the selection soft capsule of diluent is commonly used has soybean oil and PEG400 etc., and Herba Erigerontis extractum dissolubility in PEG400 is better among the we, does not dissolve in vegetable oil, and layering is separated out easily.So select PEG400 as diluent.
2. the consumption of the selection diluent of diluent consumption directly has influence on the loading amount and the content uniformity of soft capsule.Because this product content of dispersion is less, diluent ratio is low excessively, and then medicinal liquid is mobile bad, and is also high to the production equipment requirement, can cause fill difficulty, content uniformity bigger.Diluent ratio is excessive, then can cause production cost to increase, and causes the patient to take too much adjuvant.Therefore screen the diluent of different proportion, thereby determined the optimal proportion scope.Get Herba Erigerontis extractum 50g, add not commensurability PEG400 respectively, fully mix, observe the medicinal liquid flowability after colloid mill ground 10 minutes, and the compacting soft capsule, investigate compacting pouring process and the capsular content uniformity of gained, the results are shown in following table.
The selection result of the test of diluent ratio
| Medical material: diluent | The medicinal liquid flowability | Pressing process | Loading amount (g) | Content uniformity |
| 2000∶330 | The medicinal liquid thickness, mobile poor | The compacting difficulty, sprinkler body easily stops up | ?0.451 | ---- |
| 2000∶335 | Medicinal liquid is than thickness, and is mobile relatively poor | Compacting is difficulty slightly, and sprinkler body easily stops up | ?0.489 | 7.2％ |
| 2000∶338.4 | The medicinal liquid denseness is suitable, and is better mobile | Compacting is smooth, no sprinkler body clogging | ?0.526 | 4.9％ |
| 2000∶340 | Medicinal liquid is rarer, good fluidity | Compacting is smooth, no sprinkler body clogging | ?0.564 | 5.2％ |
By result in the table as can be known, when the ratio of medicated powder and diluent is 2000: 338.4 and 2000: 340.0, the medicinal liquid denseness is suitable, better mobile, fill is smooth, and the soft capsule content uniformity is little, but both do not have notable difference, and the former supplementary product consumption is less, is 2000: 338.4 so select the ratio of medical material and diluent.
3. the glycerol consumption is selected because PEG400 has induration to softgel shell, according to bibliographical information, adds an amount of glycerol to reduce hardness, improves the water sorption of Polyethylene Glycol to the glue shell, and the consumption of glycerol is investigated.Get Herba Erigerontis medical material 2000g respectively, adding PEG400 338.4g and glycerol are an amount of, fully mix after colloid mill ground 10 minutes the compacting soft capsule.Get the gained soft capsule,, placed 20 days in the calorstat of relative humidity 75% (putting in the container of saturated aqueous sodium chloride), investigate hardness, the disintegrate situation of the soft capsule of different glycerol consumptions 37 ℃～40 ℃ of temperature.The results are shown in following table
The glycerol consumption is selected
| Time | Glycerol consumption (%) | Disintegration time (minute) | Softgel shell hardness |
| 0 day | 0 | 9.1 | + |
| 26.3 | 9.3 | + | |
| 30 | 9.0 | + | |
| 5 days | 0 | 12.0 | ++ |
| 5 | 9.9 | + | |
| 10 | 9.6 | + | |
| 10 days | 0 | 15.8 | ++ |
| 263 | 10.9 | + | |
| 30 | 10.5 | + | |
| 20 days | 0 | 20.7 | +++ |
| 26.3 | 11.6 | + | |
| 30 | 11.8 | + |
Annotate: "+" multilist more shows that softgel shell is hard more.Glycerol percentage consumption is that radix calculates with the consumption of Herba Erigerontis extractum and PEG400, and is as follows.
Last table result shows, the soft capsule of glycerol adding not, and in above-mentioned condition, along with the prolongation of storage time, the product disintegration time obviously prolongs, and softgel shell hardness strengthens; After adding glycerol, the stability of product obviously strengthens, but not obviously difference of consumption 26.3g and consumption 30g is 26.3g so select the glycerol addition.
4. soft capsule shell prescription proportioning screening
Softgel shell basis prescription selects softgel shell basis prescription to adopt soft capsule gelatin, purified water prescription commonly used, and both usage ratio are gelatin: water=100: 100
The purpose of plasticizer selection adding plasticizer is to increase the plasticity of soft capsule, guarantees the good stretchability of soft capsule goods; Long-term its hardness that keeps makes it not yielding.Document shows that glycerol does not almost have influence as plasticizer to dissolution rate.And can form a stable thermal reversibility gel network, thereby be suitable for use as the plasticizer of soft capsule most.The usage ratio of glycerol and gelatin is selected commonly used 0.35: 1, and the too little then softgel shell of consumption is hard, crisp, poor plasticity, and too greatly then softgel shell is softer for consumption, than being easier to the moisture absorption and extrusion, and the soft capsule drying time of can extending.
Disintegrating agent selects studies show that the PEG400 of adding gelatin amount 5% can shorten disintegration time effectively as auxiliary disintegrating agent in the softgel shell prescription, so be chosen in the auxiliary disintegrating agent of PEG400 conduct that adds gelatin amount 5% in the softgel shell prescription.
0.2% the Brown Ferric Oxide that screening agent select to add the gelatin amount is a screening agent, makes cyst membrane opaque, to reduce the soft capsule shell transmittance, increases stability of drug; And make soft capsule more attractive in appearance.
Antiseptic is selected because gelatin is come by the animal bone preparation, when soft capsule leaves in the bigger environment of excess moisture or humidity, can cause putrid and deteriorated, so adding ethyl hydroxybenzoate and propyl hydroxybenzoate as antiseptic, consumption is respectively 0.2% of gelatin amount.
This consists of the soft capsule of softgel shell, and at duration of storage, content is stable, and the product disintegrate is good.In sum, soft capsule shell prescription ratio is defined as:
Gelatin 100g purified water 100g glycerol 35g PEG400 5g
Brown Ferric Oxide 0.2g ethyl hydroxybenzoate 0.2g propyl hydroxybenzoate 0.2g
5. preparation process condition research
Medicine degree of grinding investigation medicine degree of grinding too Xiao Yi causes the obstruction of equipment sprinkler body, soft capsule oil impregnate etc., and degree of grinding is excessive then has relatively high expectations to disintegrating apparatus, and energy consumption increases, and production efficiency reduces, and production cost is increased.For this reason, it is an amount of to get Herba Erigerontis extractum respectively, and pulverize separately becomes varigrained fine powder, by method for making, is pressed into capsule, investigates the influence of medicine degree of grinding to production process and finished product, the results are shown in Table.
The medicine degree of grinding is investigated
| The medicine degree of grinding | The medicinal liquid situation | Production process and finished product situation |
| 60 orders | The medicinal liquid Chinese medicine is than free settling | The equipment sprinkler body easily stops up, and finished product has the seepage phenomenon |
| 80 orders | The medicinal liquid Chinese medicine is than free settling | Idol has sprinkler body to stop up generation, and finished product is the seepage phenomenon slightly |
| 100 orders | The medicinal liquid Chinese medicine is more stable, does not find medicine sedimentation situation | Produce smoothly, do not see the sprinkler body clogging, finished product is not seen seepage |
| 120 orders | The medicinal liquid Chinese medicine is more stable, does not find medicine sedimentation situation | Produce smoothly, do not see the sprinkler body clogging, do not see the finished product seepage |
Above-mentioned result of the test shows, medicine pulverizing medicinal liquid Chinese medicine between 100～120 orders is more stable, do not find medicine sedimentation situation, produce smoothly, do not see the sprinkler body clogging, finished product is not seen oil impregnate, because the medicine degree of grinding is 100 mesh sieves and the not obviously difference of 120 mesh sieves, in order to improve screening efficiency, so select medicine is crossed 100 mesh sieves.
The colloid mill incorporation time selection to get Herba Erigerontis extractum an amount of, add each adjuvant by method for making, make medicinal liquid, put and mix 5,10,15 minutes in the colloid mill, colloid mill mill spacing 5um, is the control temperature 50 during grinding? below, compare gained medicinal liquid situation.By the result as can be known, mixed 15 minutes and 10 minutes medicinal liquid situation zero differences, but all be better than mixing 5 minutes.So determine to mix 10 minutes with colloid mill.
Incorporation time selection
| Incorporation time | The medicinal liquid situation |
| 5 minutes | Medicinal liquid has granular sensation, mixes inhomogeneous |
| 10 minutes | Medicinal liquid is even, the feel exquisiteness |
| 15 minutes | Medicinal liquid is even, the feel exquisiteness |
In the pressing process that is chosen in soft capsule of sprinkler body temperature, the sprinkler body temperature is the key factor that influences soft capsule content uniformity and yield rate, and the sprinkler body temperature is low excessively, and the capsule pressing is bad, leakage easily; The sprinkler body temperature is too high, can influence the outward appearance of soft capsule.Investigate the pressing situation of soft capsule under the different temperatures for this reason, the results are shown in following table.
The selection result of the test of sprinkler body temperature
| The sprinkler body temperature | Soft capsule pressing and forming situation |
| 38～42℃ | Pressing is bad, leakage easily |
| 42～46℃ | Good moldability, the yield rate height, content uniformity is little |
| 46～48℃ | The soft capsule appearance poor, the out-of-flatness of pressing position |
As seen from the experiment, the sprinkler body temperature should be controlled at 42～46 ℃ and is advisable.
Select to get soft capsule drying time, routinely, 2～3 hours (24～28 ℃ of the temperature of finalizing the design, relative humidity 40～60%) after, use the rotating cage seasoning, dry different time (24～28 ℃ of temperature, relative humidity 20～40%) is investigated product softgel shell water content and dry back finished product situation (disintegrate, outward appearance) respectively.Investigation is the result show, this product drying time can not be too short, otherwise finished product is softer, and easy to leak in storage period can not be oversize, otherwise finished product is harder, and softgel shell is more crisp, easily splits, to be advisable 10 hours drying times.See the following form:
Select drying time
| Drying time (h) | Softgel shell water content (%) | The finished product outward appearance | Disintegration time (branch) |
| ?6 | 19.5 | Finished product is softer, easy to leak in storage period | 9.2 |
| ?10 | 12.9 | Finished product is attractive in appearance, and hardness is suitable, steady quality | 8.5 |
| ?12 | 7.6 | Finished product is harder, and softgel shell is more crisp, easily splits | 12.2 |
(4) drop pill Study on Forming:
Melt temperature: press medicine and substrate composition, medicine and substrate are put in the water-bath of different temperatures and heat, fusion,, pour drop pill in the drop pill machine into.With the whole degree of pill shaped circle, oozing difficulty or ease is index, will investigate the result by good to poorly using " +++" successively, " ++ ", "+", "-" represents.
| Melt temperature/℃ | Roundness | Ooze state |
| 60 | - | Can not drip |
| 65 | +++ | Easily ooze |
| 70 | + | Slower |
| 75 | + | Slower |
2. drip the system temperature: press medicine and substrate composition, medicine and substrate are put in 70 ℃ the water-bath and heat, fusion is poured in the drop pill machine, different temperatures insulation, drop pill.With the whole degree of pill shaped circle, oozing difficulty or ease is index, with the investigation result of each index by good to poorly using " +++" successively, " ++ ", "+", "-" expression.
| Drip the system temperature/℃ | Roundness | Ooze state |
| 70 | - | Can not drip |
| 75 | +++ | Easily ooze |
| 80 | + | Slower |
| 85 | + | Too fast |
The result shows that optimised process is 65 ℃ of melt temperatures, drips 75 ℃ of system temperature.
(5) effervescent tablet
1. the selection of coating material
Coating material
| Group | Internal layer | Outer |
| 1 | - | - |
| 2 | Add titanium dioxide acrylic resin II number | Acrylic resin II number |
| 3 | Radix Acaciae senegalis adds titanium dioxide | Acrylic resin IV number |
| 4 | PVP adds titanium dioxide | Acrylic resin II number |
| 5 | Add titanium dioxide acrylic resin IV number | Acrylic resin IV number |
Screening experiment
| Group | Disintegration time min | Outward appearance (0 month) | Outward appearance (June) |
| 1 | 8.15 | Smooth | The moisture absorption |
| 2 | 10.23 | Smooth | Smooth |
| 3 | 8.24 | Smooth | Film-coat damaged portion label exposes the moisture absorption |
| 4 | 5.54 | Smooth | Smooth |
| 5 | 9.11 | Smooth | Film-coat damaged portion label exposes the moisture absorption |
Experimental result as can be known because effervescent tablet is made up of two components of soda acid, there are meta-acid or alkali phenomenon partially in the part, can make acrylic resin be subjected to the influence of soda acid and destroys, institute's internal layer has added PVP and has added titanium dioxide, makes the isolation of acrylic resin and label, acid and alkali alkali destruction.
2. the screening of art for coating.
The art for coating uniform designs table
| The experiment number | The sheet bed tempertaure (℃) | Jet velocity ml/kgmin (s) | Outward appearance |
| 1 | - | - | - |
| 2 | 40 | 6.0 | Well |
| 3 | 50 | 6.5 | Bonding die, pitted skin |
| 4 | 50 | 6.5 | Mottle is arranged |
| 5 | 60 | 6.0 | Fineness is relatively poor |
| 6 | 60 | 6.5 | Pericarpium Citri Reticulatae, unfilled corner |
Experimental result as can be known, coating material: internal layer uses PVP to add titanium dioxide, the outer acrylic resin II that uses, during 40 ℃ of sheet bed tempertaures, jet velocity 6.0ml/kgmin promptly gets effervescent tablet.
(6) gel
The influence of total flavones retention rate when 1. sucrose adds heating
Temperature (80 ℃) heating 30min
| Sucrose | Sucrose 8% | Sucrose 10% | Sucrose 15% | |
| General flavone content % | 92.17 | 96.56 | 99.88 | 96.21 |
The result shows that during with sucrose, behind 80 ℃ of heating 30min, resolution ratio is about 8%; And after the interpolation sucrose, resolution ratio is less than 5%.
2. sucrose is to the influence of substrate:
| Carrageenan % | Sucrose % | The carrageenan solution temperature (℃) |
| 0.9 | - | 80 |
| 0.9 | 8 | 83 |
| 0.9 | 10 | 91 |
| 0.9 | 15 | 90 |
The result shows that the sucrose consumption is excessive, can increase the content of solidity thing in the gel solution, improves the dissolving of selected substrate carrageenan, agglomerative temperature, is unfavorable for the stable of flavone, so select 0.9% carrageenan, 10% sucrose as substrate.
Experimental example 2: contrast experiment
(1) check disintegration: adopting changes the basket method, and the lift disintegration tester is got 6, observes the situation by screen cloth, and percent of pass height then disintegrative is good, more pleasant bulk absorption
| Group | Disintegration time |
| Herba asari capsule | 25min |
| Micropill of the present invention | 2.25min |
| Dispersible tablet of the present invention | 35sec |
(2) release experiment: simulated gastric fluid-95% ethanol (3: 2) is solvent, 37 ± 0.5 ℃ 100 rev/mins.Get Herba Erigerontis sheet, soft capsule of the present invention, drop pill of the present invention, put and get the 6ml solvent when changeing in the basket respectively at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 90min, put immediately in the centrifuge tube with 4,000 rev/mins of centrifugal 5min, get supernatant 5ml, thin up is to 10ml, content with high-efficient liquid phase technique mensuration silibinin lamp-dish flower acetic calculates the cumulative percentage rate that discharges.
Discharge cumulative percentage rate %
| The Herba Erigerontis sheet | Drop pill of the present invention | Soft capsule of the present invention | |
| 5min | 9.50 | 84.15 | 83.40 |
| 10min | 40.23 | 93.28 | 95.53 |
| 20min | 65.57 | 95.60 | 96.78 |
| 30min | 68.70 | 96.68 | 97.16 |
| 40min | 78.54 | 98.79 | 98.25 |
| 50min | 87.68 | 100.00 | 99.76 |
| 60min | 89.79 | 100.10 | 100.00 |
| 90min | 95.62 | 101.10 | 100.10 |
The result shows that preparation release of the present invention is significantly better than tablet.
(3) stability experiment
1. soft capsule of the present invention
2. Herba Erigerontis oral liquid
Experimental example 3: pharmacodynamic experiment
(1) to the influence of stasis syndrome rat blood rheological characteristic
60 of rats, male and female half and half, body weight 270 ± 25g.Successive administration 12 days, 1h after the last administration, all the other respectively organize equal ivsc injection epinephrine 0.8mg/kg, totally twice, two minor tick 4h except that the normal control group.(front and back each 2 hours at interval) immerse 5min in the frozen water, fasting with rat between twice.Femoral artery blood sampling in morning next day, each index of hemorheology is measured in the heparin sodium anticoagulant.
| Group | Dosage (g/kg) | Whole blood viscosity | ||
| Height is cut | In cut | Low cutting | ||
| Normal control | - | 5.22±1.01 | 7.85±1.35 | 14.57±1.52 |
| The model contrast | - | 6.81±1.53 | 8.60±1.76 | 16.33±2.43 |
| The Herba Erigerontis tablet group | 6.0 | 6.02±0.24 | 8.02±1.52 | 16.10±4.75 |
| Herba Erigerontis capsule | 6.0 | 5.63±1.53 | 7.90±2.14 | 14.74±3.24 |
| Dispersible tablet group of the present invention | 6.0 | 5.60±0.02 | 7.81±1.61 | 14.65±2.40 |
The result shows that Breviscapine is different with the fleabane preparation curative effect, preparation good effect of the present invention.
(2) platelet aggregation mensuration
Get 50 of SD kind rats, male and female half and half, body weight 200～250g is divided into 5 groups at random, and 10 every group, gastric infusion, 1 time/day, continuous 7 days.30min after the last administration, left side internal carotid artery injection blood clot diameter is less than the thrombosis suspension 0.4ml modeling of 0.1mm, the dyeing of common carotid artery injection Gentian Violet, put to death animal, open cranium and take out cerebral tissue, claim full brain heavy, downcut undyed cerebral tissue (being the ischemic region cerebral tissue) then and weigh, obtain the percentage rate that it accounts for full brain weight, the results are shown in following table.
The effect of injection use compound Semen Ginkgo minimizing rat cerebral ischemia percentage rate (X ± SD)
| Group | Dosage (g/kg) | Mus number (only) | Full brain weight (g) | Ischemic region weight (g) | Rat cerebral ischemia percentage rate (%) |
| Model group | -- | 10 | 1.73±0.22 | 0.78±0.11 | 45.16±7.54 |
| The SHUXUENING ZHUSHEYE group | 2.0 | 10 | 1.68±0.17 | 0.53±0.11 | 31.33±10.09 |
| The capsule group | 2.0 | 10 | 1.67±0.24 | 0.62±0.09 | 37.04±7.14 |
| The oral liquid group | 2.0 | 10 | 1.68±0.21 | 0.67±0.12 | 40.16±6.13 |
| The granule group | 2.0 | 10 | 1.73±0.17 | 0.72±0.14 | 41.71±8.52 |
| Dispersible tablet group of the present invention | 2.0 | 10 | 1.69±0.12 | 0.54±0.20 | 32.02±8.12 |
| Soft capsule group of the present invention | 2.0 | 10 | 1.64±0.24 | 0.62±0.11 | 36.94±7.08 |
| Drop pill group of the present invention | 2.0 | 10 | 1.62±0.13 | 0.71±0.13 | 42.86±5.19 |
| Micropill group of the present invention | 2.0 | 10 | 1.71±0.22 | 0.73±0.10 | 42.01±7.75 |
The result of table shows that each preparation group of the present invention can obviously reduce focal cerebral ischemia rat ischemia district's weight and cerebral ischemia percentage ratio, and effect and granule, oral liquid and capsule are suitable.
Concrete embodiment:
Embodiments of the invention 1: get Herba Erigerontis medical material 500g, chopping is with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts filter, and filtrate merges, add an amount of active carbon, boil, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, measuring general flavone content according to the method under the assay item makes every to contain total flavones is 45mg, behind starch adjustment content, drying under reduced pressure gets extract, and extract is pulverized, sieve, add suitable adjuvant, use the colloid mill mix homogeneously, select suitable softgel shell prescription and pressing conditions for use, the compacting soft capsule, dryness finalization promptly gets soft capsule, three times on the one, one time 3, oral.
Embodiments of the invention 2: get the Herba Erigerontis medical material, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts filter, and filtrate merges, add active carbon, the consumption of active carbon is 2% of a medicinal liquid total amount, boils 15 minutes, filters, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, measure general flavone content according to the method under the assay item and make every to contain total flavones be 45mg, adjust content with starch after, drying under reduced pressure gets extract, extract is pulverized, cross 100 mesh sieves, press the Herba Erigerontis medical material: PEG400: glycerol=add adjuvant at 2000: 338.4: 26.3, use the colloid mill mix homogeneously, select suitable softgel shell prescription and pressing conditions for use, soft capsule shell prescription ratio is defined as: gelatin 100g, purified water 100g, glycerol 35g, the 5g PEG400, Brown Ferric Oxide 0.2g, ethyl hydroxybenzoate 0.2g, propyl hydroxybenzoate 0.2g, the compacting soft capsule, the sprinkler body temperature should be controlled at 42～46 ℃, dryness finalization 10 minutes, promptly.
Embodiments of the invention 3: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, add the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, by medicine: adjuvant is to add low-substituted hydroxypropyl cellulose at 2: 1, press medicine: adjuvant adds 2: 1 microcrystalline Cellulose, and mix homogeneously is crossed sieve No. 5, make wetting agent system soft material with the 8%PVP alcoholic solution, cross the sieve series grain No. 2,60 ℃ of oven dry, No. 2 sieve granulate, simultaneously by medicine: adjuvant is a tabletting behind 0.5: 1 the low-substituted hydroxypropyl cellulose mixing, place in the miniature bottom spraying type boiling granule coating machine and carry out coating, coating solution is 5% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 125Lmin
-1, atomization gas pressure 0.25Mpa, coating solution flow 0.5mLmin
-1, 20 ℃ of coating temperature promptly get dispersible tablet.
Embodiments of the invention 4: get Herba Erigerontis; chopping; with 80% alcohol heating reflux 2 times; each 1 hour; alcohol adding amount is respectively 8,6 times of amounts; filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%; boiled 15 minutes; filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, and by medicine: adjuvant is to add microcrystalline Cellulose, adding at 5: 3 in medicine: the adjuvant ratio is 1: 3 a lactose; cross the abundant mixing of 60 mesh sieves; adding concentration and be 50% ethanol is that wetting agent is made soft material, adopts and extrudes-round as a ball comminutor, extrudes rotating speed 35rmin
-1,, round as a ball 6min, round as a ball rotating speed 650rmin
-1,, make micropill, in 50 ℃ of bakings 12 hours, take out, place in the miniature bottom spraying type boiling granule coating machine and carry out coating, coating solution is 6% HPMC alcoholic solution, the coating parameter is as follows: air blast flux 120Lmin
-1, atomization gas pressure 0.22Mpa, coating solution flow 0.8mLmin
-1, 30 ℃ of coating temperature promptly get pellet.
Embodiments of the invention 5: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts, filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, adds PEG4000: PEG4000=2: in 1 the mixed-matrix, the proportioning of medicine and substrate is 1: 2, splash in the coolant methyl-silicone oil 100, a system condition is as follows: 65 ℃ of melt temperatures, drip 75 ℃ of system temperature, 1～5 ℃ of chilling temperature, drip apart from 10cm, cooling column length 23cm promptly gets drop pill.
Embodiments of the invention 6: get Herba Erigerontis, chopping is with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boils 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, dry below 80 ℃, pulverize, get extract powder, add 10% sodium bicarbonate, 10% citric acid, 1.5% aspartame pulverize separately is with the medicated powder mix homogeneously, granulate, drying, tabletting, coating, coating material: internal layer uses PVP to add titanium dioxide, the outer acrylic resin II that uses, during 40 ℃ of sheet bed tempertaures, jet velocity 6.0ml/kgmin promptly gets effervescent tablet.
Embodiments of the invention 7: get Herba Erigerontis, chopping is with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boils 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, and 1.2% carrageenan is put into cold water, make it to disperse, soak 20～30min, make the abundant water absorption and swelling of substrate, add 10% sucrose, heating adds sodium bicarbonate, transfers pH7.0, agitation and filtration then, filter the back and add the medicine clear paste under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying promptly gets gel.
Claims (17)
1. fleabane preparation, it is characterized in that: it is made by Herba Erigerontis 500～5000g; Comprise: all acceptable dosage forms on injection, powder pin, freeze-dried powder, gel, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and the membrane pharmaceutics.
2. according to the described fleabane preparation of claim 1, it is characterized in that: described preparation is dispersible tablet, soft capsule, micropill, drop pill, effervescent tablet or gel.
3. the preparation method of fleabane preparation as claimed in claim 1 or 2 is characterized in that: get the Herba Erigerontis medical material, and chopping, water or ethanol extraction, extracting solution filters, and the filtrate decolouring is condensed into thick paste, adds the preparation that suitable adjuvant is made needs again.
4. according to the preparation method of the described fleabane preparation of claim 3, it is characterized in that: the soft capsule in the described preparation prepares like this: get the Herba Erigerontis medical material, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts, filter, filtrate merges, and adds an amount of active carbon, boil, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, and making every according to assay item method mensuration general flavone content down, to contain total flavones be 45mg, behind starch adjustment content, drying under reduced pressure gets extract, and extract is pulverized, and sieves, add suitable adjuvant, use the colloid mill mix homogeneously, select suitable softgel shell prescription and pressing conditions for use, the compacting soft capsule, dryness finalization, promptly.
5. according to the preparation method of the described fleabane preparation of claim 4, it is characterized in that: in w/v, the consumption of active carbon is 2% of a medicinal liquid total amount.
6. according to the preparation method of the described fleabane preparation of claim 4, it is characterized in that: the time that adds the active carbon boiling decoloring is 15 minutes.
7. according to the preparation method of the described fleabane preparation of claim 4, it is characterized in that: the order number of Herba Erigerontis extract grinding and sieving is 100 orders.
8. according to the preparation method of the described fleabane preparation of claim 4, it is characterized in that: selected pharmaceutical adjunct is PEG400 and glycerol.
9. according to the preparation method of the described fleabane preparation of claim 4, it is characterized in that: the ratio of pharmaceutical adjunct and medical material is: Herba Erigerontis medical material: PEG400: glycerol=2000: 338.4: 26.3.
10. according to the preparation method of the described fleabane preparation of claim 4, it is characterized in that: soft capsule shell prescription ratio is: gelatin 100g, purified water 100g, glycerol 35g, PEG400 5g, Brown Ferric Oxide 0.2g, ethyl hydroxybenzoate 0.2g, propyl hydroxybenzoate 0.2g.
11. the preparation method according to the described fleabane preparation of claim 4 is characterized in that: the sprinkler body temperature in the soft capsule pressing process should be controlled at 42～46 ℃.
12. the preparation method according to the described fleabane preparation of claim 4 is characterized in that: the dryness finalization time after the soft capsule compacting is finished is 10 minutes.
13. the preparation method according to the described fleabane preparation of claim 3 is characterized in that:
Dispersible tablet in the described preparation prepares like this: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, add the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, by medicine: adjuvant is to add low-substituted hydroxypropyl cellulose at 2: 1, by medicine: adjuvant is 2: 1 a microcrystalline Cellulose, and mix homogeneously is crossed sieve No. 5, make wetting agent system soft material with the 8%PVP alcoholic solution, cross the sieve series grain No. 2,60 ℃ of oven dry, No. 2 sieve granulate, simultaneously by medicine: adjuvant is a tabletting behind 0.5: 1 the low-substituted hydroxypropyl cellulose mixing, place in the miniature bottom spraying type boiling granule coating machine and carry out coating, coating solution is 5% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 125Lmin-1, atomization gas pressure 0.25Mpa, coating solution flow 0.5mLmin-1,20 ℃ of coating temperature, promptly.
14. the preparation method according to the described fleabane preparation of claim 3 is characterized in that:
Pellet in the described preparation prepares like this: get Herba Erigerontis, chopping is with 80% alcohol heating reflux 2 times; each 1 hour, alcohol adding amount was respectively 8; 6 times of amounts filter; filtrate merges; add the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter; it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities; by medicine: adjuvant is to add microcrystalline Cellulose at 5: 3; by medicine: adjuvant is 1: 3 a lactose, crosses the abundant mixing of 60 mesh sieves, and adding concentration and be 50% ethanol is that wetting agent is made soft material; employing is extruded-round as a ball comminutor; extrude rotating speed 35rmin-1,, round as a ball 6min; round as a ball rotating speed 650rmin-1;, make micropill, in 50 ℃ of bakings 12 hours; take out; place in the miniature bottom spraying type boiling granule coating machine and carry out coating, coating solution is 6% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 120Lmin-1; atomization gas pressure 0.22Mpa; coating solution flow 0.8mLmin-1,30 ℃ of coating temperature, promptly.
15. the preparation method according to the described fleabane preparation of claim 3 is characterized in that:
Drop pill in the described preparation prepares like this: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts, filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, adds PEG4000: PEG4000=2: in 1 the mixed-matrix, the proportioning of medicine and substrate is 1: 2, splash in the coolant methyl-silicone oil 100, a system condition is as follows: 65 ℃ of melt temperatures, drip 75 ℃ of system temperature, 1～5 ℃ of chilling temperature, drip apart from 10cm, cooling column length 23cm, promptly.
16. the preparation method according to the described fleabane preparation of claim 3 is characterized in that:
Effervescent tablet in the described preparation prepares like this: get Herba Erigerontis, chopping, with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount is respectively 8,6 times of amounts, filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boiled 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, dry below 80 ℃, pulverize, get extract powder, add 10% sodium bicarbonate, 10% citric acid, 1.5% aspartame pulverize separately is with the medicated powder mix homogeneously, granulate, drying, tabletting, coating, coating material: internal layer uses PVP to add titanium dioxide, the outer acrylic resin II that uses, during 40 ℃ of sheet bed tempertaures, jet velocity 6.0ml/kgmin, promptly.
17. the preparation method according to the described fleabane preparation of claim 3 is characterized in that:
Gel in the described preparation prepares like this: get Herba Erigerontis, chopping is with 80% alcohol heating reflux 2 times, each 1 hour, alcohol adding amount was respectively 8,6 times of amounts filter, filtrate merges, and adds the active carbon of amount of liquid medicine 2%, boils 15 minutes, filter, it is 1.30～1.35 thick paste that filtrate decompression is condensed into 50 ℃ of relative densities, and 1.2% carrageenan is put into cold water, make it to disperse, soak 20～30min, make the abundant water absorption and swelling of substrate, add 10% sucrose, heating adds sodium bicarbonate, transfers pH7.0, agitation and filtration then, filter the back and add the medicine clear paste under condition of stirring, mix homogeneously joins rapidly in the disinfecting container, seal, sterilization is cooled to about 30 ℃ condensation rapidly, drying, promptly.
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|---|---|---|---|
| CNA2005102004667A CN1853660A (en) | 2004-08-13 | 2005-08-12 | Erigeron breviscapus preparation and making method thereof |
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|---|---|---|---|
| CN200410040462.2 | 2004-08-13 | ||
| CN 200410040462 CN1626208A (en) | 2004-08-13 | 2004-08-13 | Preparation of fleabane and preparation method |
| CNA2005102004667A CN1853660A (en) | 2004-08-13 | 2005-08-12 | Erigeron breviscapus preparation and making method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101632723B (en) * | 2008-07-25 | 2011-10-26 | 贵州益佰制药股份有限公司 | Application of compound polygonum orientale preparation in preventing and treating climacteric diseases and delaying senility |
| CN102614240A (en) * | 2012-04-26 | 2012-08-01 | 王祥红 | Extract containing breviscapine and preparation method thereof |
| CN104906160A (en) * | 2015-05-25 | 2015-09-16 | 昆明理工大学 | Enteric preparation of erigeron breviscapus extractive |
| CN105412045A (en) * | 2015-12-15 | 2016-03-23 | 广西大海阳光药业有限公司 | Method for preparing Yimaikang micro-capsule |
| CN114557976A (en) * | 2022-04-02 | 2022-05-31 | 复旦大学 | Scutellarin sustained-release tablet and preparation method thereof |
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2005
- 2005-08-12 CN CNA2005102004667A patent/CN1853660A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101632723B (en) * | 2008-07-25 | 2011-10-26 | 贵州益佰制药股份有限公司 | Application of compound polygonum orientale preparation in preventing and treating climacteric diseases and delaying senility |
| CN102614240A (en) * | 2012-04-26 | 2012-08-01 | 王祥红 | Extract containing breviscapine and preparation method thereof |
| CN102614240B (en) * | 2012-04-26 | 2013-07-31 | 王祥红 | Extract containing breviscapine and preparation method thereof |
| CN104906160A (en) * | 2015-05-25 | 2015-09-16 | 昆明理工大学 | Enteric preparation of erigeron breviscapus extractive |
| CN104906160B (en) * | 2015-05-25 | 2018-07-24 | 昆明理工大学 | A kind of enteric coated preparations of erigeron breviscapus extract |
| CN105412045A (en) * | 2015-12-15 | 2016-03-23 | 广西大海阳光药业有限公司 | Method for preparing Yimaikang micro-capsule |
| CN105412045B (en) * | 2015-12-15 | 2018-08-24 | 广西大海阳光药业有限公司 | A kind of preparation method of benefit arteries and veins health micro-capsule |
| CN114557976A (en) * | 2022-04-02 | 2022-05-31 | 复旦大学 | Scutellarin sustained-release tablet and preparation method thereof |
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