CN1650881A - Erigeron breviscapus medicinal preparation and its preparation method - Google Patents
Erigeron breviscapus medicinal preparation and its preparation method Download PDFInfo
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Abstract
A breviscapine in the form of micropill, dispersing tablet, or soft capsule for preventing and treating cardiovascular and cerebrovascular diseases and ischemic and hemorrhagic cerebrovascula squelae and its preparing process are disclosed.
Description
Technical field: the present invention is a kind of erigeron breviscapus medicinal preparation and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: calcium overload in the neurocyte, extracellular excitatory amino acid (EAA) is piled up, free radical production increases, it is the 4 big factors that the generally acknowledged ischemia of domestic and international Most scholars causes brain injury or neuronal apoptosis that the transition activation of protein kinase C (PKC) or displacement activate, therefore, can prevent thrombosis, thrombus, improve hemorheology, suppress platelet aggregation, accelerate cerebral blood flow, improve brain microcirculation, suppressing PKC transition activation or displacement activates, suppress the EAA amino acid extracellular and pile up and intracellular calcium overload, prevent that oxygen-derived free radicals from generating the medicine that increases and can both prevent the impaired and neuronal apoptosis of ischemic cranial nerve function.The present just more comprehensive medicine of above-mentioned functions of breviscapine, thereby become the choice drug of preventing and treating ischemic and bleeding type cerebrovascular sequelae.The effective ingredient that extracts in the Herba Erigerontis prime system Chinese medicine Herba Erigerontis (the short booth Herba Erigerontis aceris of feverfew), the mixture for oil lamp cycle of sixty years element and second element mainly contains lamp-dish flower acetic, and its chemical formal name used at school is: 4,5,6-trihydroxyflavone-7 glucuronide.Breviscapine is since last century, succeeded in developing the seventies, and 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: Herba Erigerontis tablet that has gone on the market and injection, but the dosage form of tablet falls behind, and product quality is not ideal enough, and the dosage form kind is abundant inadequately, is suitable for crowd's narrow range, takes often, and bioavailability is low, medicine stability is undesirable; The injection service condition is limited, and poor stability is not suitable for long term administration, so existing preparation is difficult to reach ideal curative effect; Because breviscapine indissoluble in water, though easily dissolving but character is extremely unstable in aqueous alkali, so pharmacy worker attempts to solve the problem of Breviscapine bioavailability difference, and the applicant is being " 981065996 " to the disclosed number of patent application of Chinese patent gazette, name is called " erigeron breviscopus element soft capsule and production method thereof ", number of patent application is " 02153445.4 ", name is called " prescription of breviscapine drop pills and preparation method ", number of patent application is " 01133515.7 ", name is called " breviscapine dispersible tablet and preparation method thereof ", number of patent application is " 02128082.7 ", name is called the patent application of " herba florigen oral drip-ball and production method thereof " and carries out finding in the research process, though the drop pill of common process preparation, soft capsule is higher slightly than the bioavailability of ordinary tablet, but still has certain problem: mainly be that breviscapine still is not very desirable in absorption by human body; Easy deliquescing, bonding if drop pill use routine techniques, the product that makes make moist; It is sticking that the granule of dispersible tablet is met waterishlogging, little with the gastrointestinal contact surface, influenced the disintegrate and the dissolution rate of medicine; The cyst membrane of soft capsule is many with compositions such as a certain proportion of gelatin, G ﹠ Ws, the character of its main component gelatin all seems very important to formability, the dissolubility of softgel shell, with the gelatin is the soft capsule of glue shell Main Ingredients and Appearance, because gelatin self is with the passing of time aging, in storage period disintegration defective, influence the bioavailability of product.In view of such circumstances, need to seek a kind of therapeutic effect ideal, technology advanced person, the erigeron breviscapus medicinal preparation that bioavailability is high.
Summary of the invention: the objective of the invention is to: a kind of erigeron breviscapus medicinal preparation and preparation method thereof is provided; This pharmaceutical preparation is to be prepared into breviscapine to disperse sheet, soft capsule or dropping pill formulation; Dispersible tablet provided by the invention adopts the micropill granulation technique, and the product disintegrative is good, has improved the bioavailability of effective ingredient, is particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take; Soft capsule provided by the invention can be covered poor taste, the abnormal smells from the patient of medicine, has strengthened stability, and the capsule material is difficult for softeningly, has solved the problem of prolonged disintegration; Drop pill provided by the invention adopts the drop pill packaging technique, improves drug bioavailability, increases medicine dissolution, moisture resistance; And technical maturity is stable, is beneficial to penetration and promotion.
The present invention constitutes like this: calculate according to composition by weight: it is to be made into the preparation that allows on the pharmaceuticss such as injection, powder pin, freeze-dried powder, gel, 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 membrane with adjuvant by 10～50 parts of breviscapines.Specifically: it be by breviscapine 10～50g and adjuvant be made into 1000 or dispersible tablet, soft capsule or dropping pill formulation.Dispersible tablet in the preparation of the present invention prepares like this: get breviscapine; add by medicine: the adjuvant ratio is 3: 2 a microcrystalline Cellulose, crosses the abundant mixing of 60 mesh sieves, and adding concentration is that 50% ethanol is that wetting agent is made soft material; employing is extruded-round as a ball comminutor, extrudes rotating speed 30rmin
-1, round as a ball 5min, round as a ball rotating speed 650rmin
-1, make micropill, in 50 ℃ of bakings 12 hours, take out, add by medicine: the adjuvant ratio is 2: 1 low-substituted hydroxypropyl cellulose, by medicine: the adjuvant ratio is 2: 1 a carboxymethyl starch sodium, mix homogeneously, and mistake is sieved for No. 5, make wetting agent system soft material with the 5%PVP alcoholic solution, cross the sieve series grain No. 2,60 ℃ of oven dry, No. 2 sieve granulate, add simultaneously in medicine: the adjuvant ratio is a tabletting behind 1: 2 the low-substituted hydroxypropyl cellulose mixing, promptly.
Soft capsule in the preparation of the present invention prepares like this: get breviscapine, press medicine: substrate=1: 1.3, and the mixed-matrix of adding soybean oil, edible vegetable oil, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: PFG400: water=1: 0.2: 0.05: 0.6, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70～80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 1～2 hour, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying, promptly.
Drop pill in the preparation of the present invention prepares like this: get breviscapine, with the polyoxyethylene monostearate is substrate, the proportioning of medicine and substrate is 1: 2, mixing, splash in the coolant methyl-silicone oil, it is as follows to drip the system condition: 70 ℃ of melt temperatures, system is dripped in insulation, 1～5 ℃ of chilling temperature, drip apart from 10cm, cool off column length 20cm, the drop pill that makes is placed in the miniature bottom spraying type boiling granule coating machine carry out coating, coating solution is 4% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 125Lmin
-1, atomization gas pressure 0.20MPa, coating solution flow 0.5mLmin
-1, 25 ℃ of coating temperature, promptly.
Compared with prior art, micropill provided by the invention, dispersible tablet, soft capsule, disintegrative is good, and dissolution is good, has solved poorly soluble breviscapine bioavailability problem; 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.Dispersible tablet provided by the invention; adopt the micropill granulation technique, add in medicine: the adjuvant ratio is 3: 2 a microcrystalline Cellulose, crosses the abundant mixing of 60 mesh sieves; add concentration and be 50% ethanol and be wetting agent and make soft material and adopt and extrude-round as a ball comminutor, extrude rotating speed 30rmin
-1, round as a ball 5min, round as a ball rotating speed 650rmin
-1, make tabletting behind the micropill, make medicine increase at the area on gastrointestinal tract surface, solve granule and met the sticking problem that influences disintegrate of waterishlogging, improved bioavailability of medicament, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take; Soft capsule provided by the invention, can cover poor taste, the abnormal smells from the patient of medicine, strengthen stability, and in the capsule material, add the auxiliary disintegrating agent of PEG400 conduct of gelatin amount 5%, improve the aging prolonged disintegration problem that causes of gelatin, effectively shortened disintegration time; It is coating solution that drop pill adopts the 4%HPMC alcoholic solution, and air blast flux 125Lmin
-1, atomization gas pressure 0.20MPa, coating solution flow 0.5mLmin
-1, the process conditions that the coating temperature is 25 ℃, the drop pill moisture-resisting that makes is strong, good stability, drug dissolution height; 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.Can effectively prevent and treat ischemic and bleeding type cerebrovascular sequelae; Except the treatment cardiovascular and cerebrovascular disease, preparation of the present invention can also be treated hepatitis, liver cirrhosis, senile dementia, pulmonary heart disease, vertebra-basilar artery ischemia, hepatitis, liver cirrhosis, acute pancreatitis, gastric ulcer etc., effect is also more satisfactory, has reached the purpose of invention.
Experimental example 1: Study on Forming
(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. micropill granulating process research
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.
The round as a ball rotating speed rmin of the round as a ball time min of group concentration of alcohol %
-1Bulk density gmL
-1
1 30 5 650 0.70
2 30 8 700 0.72
3 40 5 650 0.73
4 40 8 700 0.75
5 50 5 650 0.81
6 50 8 700 0.72
The result shows, the optimum process 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 5min, round as a ball rotating speed 650rmin
-1
2. tablet forming technique research
Group low-substituted hydroxypropyl cellulose low-substituted hydroxypropyl cellulose carboxymethyl starch sodium PVP alcoholic solution dispersing uniformity
In add (medicine: adjuvant) add (medicine: (medicine: concentration % adjuvant) adjuvant)
1 1.5: 11: 13: 16 become sticking group
2 1.5: 1-3: 16 thicker
3 1.5: 11: 1-5 thicker
42: 11: 22: 15 is qualified
52: 1-2: 14 become sticking group
62: 11: 2-4 thicker
The result shows, optimum process condition is for adding in medicine: the adjuvant ratio is 2: 1 low-substituted hydroxypropyl cellulose, in medicine: the adjuvant ratio is 2: 1 a carboxymethyl starch sodium, mix homogeneously, cross sieve No. 5, make wetting agent system soft material with the 5%PVP alcoholic solution, cross No. 2 sieve series grains, 60 ℃ of oven dry, No. 2 sieve granulate add simultaneously in medicine: the adjuvant ratio is a tabletting behind 1: 2 the low-substituted hydroxypropyl cellulose mixing.
3. 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.
The group disintegration time
Herba Erigerontis tablet 25.4min
The dispersible tablet 4.2min that granulates of micropill not
Dispersible tablet 55sec of the present invention
The result shows that micropill makes dispersible tablet after granulating, and makes medicine increase at the area on gastrointestinal tract surface, has solved granule and has met the sticking problem that influences disintegrate of waterishlogging, has improved the bioavailability of breviscapine.
(2) drop pill Study on Forming
1. drip the system technical study
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 oozes state
65-can not drip
70 +++easily ooze
75 ++ slower
80+slower
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, and different temperatures is incubated, 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 system temperature/℃ roundness and ooze state
65-can not drip
70 +++easily ooze
75 ++ very fast
80+too is fast
The result shows that optimised process is 70 ℃ of melt temperatures, drips 70 ℃ of system temperature.
2. art for coating research
Table 1 coating solution flow/mLmin
-1Atomizing effect
0.4 general, a small amount of big droplet is arranged
0.5 good, there is not big droplet
0.8 general, a small amount of big droplet is arranged
1.0 poor, more big droplet is arranged
Table 2 coating temperature/℃ coating effect
20 is general, and many glutinous companies are arranged
25 is good, not glutinous company the between the micropill
30 is better, and micropill has seldom to be measured glutinous the company
35 is better, and micropill has seldom to be measured glutinous the company
Table 3 study on the stability
Outward appearance
0 month 12 months June of group
Not coated drop pill rounding, even, bright and clean rounding, evenly, a little bonding distortion, tide knot
Drop pill rounding of the present invention, 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 0.5mLmin
-1, 25 ℃ of product moisture resistances that make of coating temperature are strong, and product stability is good.
(3) soft capsule Study on Forming
1. pill making craft research
The adsorbing base rate is investigated
Medicated powder: substrate suspension situation
1: 1.2 inhomogeneous suspension
1: 1.3 even suspension
1: 1.4 even suspension
Adjuvant is to the influence of composition:
Group breviscapine (mg/ grain)
Medicated powder 19.20
Add after the substrate 19.15
The result shows that optimum process condition is for pressing medicated powder: substrate=1: 1.2, breviscapine content did not have significant change after medicated powder added substrate.
2. capsule material screening
Disintegration time (min)
Gelatin (part) glycerol (part) water (part) PEG400 (part) December in 0 month 6 months March
1 0.2 0.6 20.5 24.8 25.9 27.2
1 0.2 0.6 0.02 20.1 23.6 24.2 25.5
1 0.2 0.6 0.05 20.3 20.8 20.9 21.2
1 0.2 0.6 0.08 20.2 23.1 24.7 25.8
The result shows that the auxiliary disintegrating agent of PEG400 conduct can shorten the disintegration time of soft capsule, but the PEG400 consumption is few, its DeGrain; Consumption is big, then because it has induration to gelatin, influences dissolubility, so with gelatin: glycerol: PFG400: water=1: 0.2: 0.05: 0.6 is the optimum formula of this product capsule material.
Experimental example 2: 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 sc 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 hits to hang down and cuts
Normal control-5.39 ± 1.25 7.79 ± 0.46 14.55 ± 1.34
Model contrast-6.77 ± 1.36 8.56 ± 1.79 16.36 ± 1.42
Herba Erigerontis tablet group 6.0 6.01 ± 0.37 8.03 ± 2.52 16.12 ± 3.46
Dispersible tablet group 6.0 5.72 of the present invention ± 0.01 7.92 ± 1.64 15.04 ± 2.51
The result shows that preparation of the present invention is better than conventional tablet to the curative effect of stasis syndrome rat blood rheological characteristic.
(2) platelet aggregation mensuration
Healthy rabbits, male and female are usefulness all, body weight 2～3kg, clear-headed certainly rabbit carotid artery is got blood, is collected in the centrifuge tube of silication with 3.8% sodium citrate anticoagulant, and blood and anticoagulant volume ratio are 9: 1.Respectively through 1000 and the centrifugal 10min of 3000rpm get platelet rich plasma (PRP) and platelet poor plasma (PPP).Press the BornShi turbidimetry, with BS-631 type autobalance platelet aggregation instrument, PRP is hatched 15min with the medicinal liquid of variable concentrations earlier, adds derivants such as ADP, AA or PAF again, and the waveform of record platelet aggregation also calculates maximum agglutination rate.Platelet aggregation inhibition rate is calculated as follows: assemble suppression ratio (%)=(1-delivery tube aggregation rate/control tube aggregation rate) * 100
The dense ADP AA of medicine PAF
Medicineρ(g/L) ρ(3μmol/L) ρ(0.35mmol/L) ρ(7.2nmol/L)
Contrast 55.0 ± 1.9 66.5 ± 2.3 55.7 ± 1.8
Tablet group 2.0 29.3 ± 4.3 28.2 ± 1.5 46.3 ± 2.6
Dispersible tablet group 2.0 29.2 of the present invention ± 3.5 22.8 ± 3.1 38.1 ± 1.7
Soft capsule group 2.0 28.3 of the present invention ± 2.0 22.5 ± 6.3 39.2 ± 1.9
Drop pill group 2.0 27.5 of the present invention ± 1.8 22.7 ± 4.8 38.8 ± 2.4
The result shows that the effect of anticoagulant of the present invention is better than conventional tablet.
(3) to the effect of rat chronic hepatic injury
Healthy Wistar rat, body weight 120～160g is divided into 5 groups: normal control group, CCl at random
4Model group, dispersible tablet group, soft capsule group, drop pill group.Adopt CCl
4Preparation rat liver fibrosis model, colchicine group, compatibility group are gastric infusion, compatibility extract 3.38g/kg, normal control group, CCl in beginning administration in the 1st day of modeling
4Model group gives the 0.9%NaCl solution of equivalent.Each treated animal is sacrificed by decapitation behind modeling 10w.Get blood system from the determination of serum liver function.
Each organizes rats'liver changes of function (x ± s)
Group n ALT (IU/L) Glb (ρ B/g/L) Alb (ρ B/g/L)
Normal group 10 38.09 ± 4.27 24.80 ± 2.41 35.93 ± 0.64
Model group 9 104.38 ± 22.34 31.62 ± 3.55 26.47 ± 2.96
Dispersible tablet group 11 60.04 ± 15.32 25.51 ± 2.73 33.25 ± 3.68
Soft capsule group 11 58.80 ± 11.10 25.19 ± 1.44 34.02 ± 1.21
Drop pill group 10 58.75 ± 5.24 25.24 ± 1.12 35.43 ± 4.38
The result shows that hepatic injury has the good curing effect to preparation of the present invention to rat chronic.
Concrete embodiment:
Embodiments of the invention 1: get breviscapine 10g, add by medicine: the adjuvant ratio is 3: 2 a microcrystalline Cellulose, crosses the abundant mixing of 60 mesh sieves, and adding concentration and be 50% ethanol is that wetting agent is made soft material, and employing is extruded-round as a ball comminutor, extrudes rotating speed 30rmin
-1, round as a ball 5min, round as a ball rotating speed 650rmin
-1, make micropill, in 50 ℃ of bakings 12 hours, take out, add in medicine: the adjuvant ratio is 2: 1 low-substituted hydroxypropyl cellulose, in medicine: the adjuvant ratio is 2: 1 a carboxymethyl starch sodium, mix homogeneously, cross sieve No. 5, make wetting agent system soft material with the 5%PVP alcoholic solution, cross No. 2 sieve series grains, 60 ℃ of oven dry, No. 2 sieve granulate, add simultaneously in medicine: the adjuvant ratio is a tabletting behind 1: 2 the low-substituted hydroxypropyl cellulose mixing, promptly gets dispersible tablet, this product oral, three times on the one, each 2.
Embodiments of the invention 2: get breviscapine 50g, press medicine: substrate=1: 1.3, the mixed-matrix of adding soybean oil, edible vegetable oil, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: PFG400: water=1: 0.2: 0.05: 0.6, getting gelatin adds an amount of distilled water and makes its imbibition, in addition the water of glycerol and remainder is put and be heated to 70～80 ℃ in the glue pot, mix homogeneously, adding expansible gelatin stirs, make it to dissolve into uniform glue,, leave standstill in 70 ℃ of insulations 1～2 hour, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying promptly gets soft capsule.
Embodiments of the invention 4: getting breviscapine 20g, is substrate with the polyoxyethylene monostearate, and the proportioning of medicine and substrate is 1: 2, mixing, splash in the coolant methyl-silicone oil, a system condition is as follows: 70 ℃ of melt temperatures, and system is dripped in insulation, 1～5 ℃ of chilling temperature, drip apart from 10cm, cool off column length 20cm, the drop pill that makes is placed in the miniature bottom spraying type boiling granule coating machine carry out coating, coating solution is 4% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 125Lmin
-1, atomization gas pressure 0.20MPa, coating solution flow 0.5mLmin
-1, 25 ℃ of coating temperature promptly get drop pill.
Embodiments of the invention 5: get breviscapine 20g, add water for injection, syrup, make 1000 bottles, promptly get oral liquid.
Embodiments of the invention 6: get breviscapine 20g, add carbomer solution, stir evenly, make 1000 bottles, promptly get gel.
Claims (5)
1, a kind of erigeron breviscapus medicinal preparation is characterized in that: calculate according to composition by weight: it is to be made into injection, powder pin, freeze-dried powder, gel, 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 membrane by 10～50 parts of breviscapines and adjuvant.
2, according to the described erigeron breviscapus medicinal preparation of claim 1, it is characterized in that: it be by breviscapine 10～50g and adjuvant be made into 1000 or dispersible tablet, soft capsule or dropping pill formulation.
3, the preparation method of erigeron breviscapus medicinal preparation as claimed in claim 1 or 2; it is characterized in that: the dispersible tablet in the described preparation prepares like this: get breviscapine; add in medicine: the adjuvant ratio is 3: 2 a microcrystalline Cellulose; cross the abundant mixing of 60 mesh sieves; adding concentration and be 50% ethanol is that wetting agent is made soft material; employing is extruded-round as a ball comminutor, extrudes rotating speed 30rmin
-1,, round as a ball 5min, round as a ball rotating speed 650rmin
-1, make micropill, in 50 ℃ of bakings 12 hours, take out, add by medicine: the adjuvant ratio is 2: 1 low-substituted hydroxypropyl cellulose, by medicine: the adjuvant ratio is 2: 1 a carboxymethyl starch sodium, mix homogeneously, and mistake is sieved for No. 5, make wetting agent system soft material with the 5%PVP alcoholic solution, cross the sieve series grain No. 2,60 ℃ of oven dry, No. 2 sieve granulate, add simultaneously in medicine: the adjuvant ratio is a tabletting behind 1: 2 the low-substituted hydroxypropyl cellulose mixing, promptly.
4, the preparation method of erigeron breviscapus medicinal preparation as claimed in claim 1 or 2, it is characterized in that: the soft capsule in the described preparation prepares like this: get breviscapine, in medicine: the ratio of substrate=1: 1.3, the mixed-matrix that adds soybean oil, edible vegetable oil, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: PFG400: water=1: 0.2: 0.05: 0.6, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70～80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 1～2 hour, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying, promptly.
5, the preparation method of erigeron breviscapus medicinal preparation as claimed in claim 1 or 2, it is characterized in that: the drop pill in the described preparation prepares like this: get breviscapine, with the polyoxyethylene monostearate is substrate, the proportioning of medicine and substrate is 1: 2, mixing, splash in the coolant methyl-silicone oil, it is as follows to drip the system condition: 70 ℃ of melt temperatures, system is dripped in insulation, and 1～5 ℃ of chilling temperature drips apart from 10cm, cooling column length 20cm, the drop pill that makes placed in the miniature bottom spraying type boiling granule coating machine carry out coating, coating solution is 4% HPMC alcoholic solution, and the coating parameter is as follows: air blast flux 125Lmin
-1, atomization gas pressure 0.20MPa, coating solution flow 0.5mLmin
-1, 25 ℃ of coating temperature, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410081323 CN1650881A (en) | 2004-11-19 | 2004-11-19 | Erigeron breviscapus medicinal preparation and its preparation method |
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| CN 200410081323 CN1650881A (en) | 2004-11-19 | 2004-11-19 | Erigeron breviscapus medicinal preparation and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1965848B (en) * | 2005-11-14 | 2010-04-21 | 王锦 | Lyophilized powder injection of breviscapinum and preparation process thereof |
| CN101757015B (en) * | 2010-01-15 | 2011-10-19 | 新乡医学院 | Composite of breviscapinum and panax notoginseng saponins Rg1 for treating pulmonary fibrosis and application thereof |
-
2004
- 2004-11-19 CN CN 200410081323 patent/CN1650881A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1965848B (en) * | 2005-11-14 | 2010-04-21 | 王锦 | Lyophilized powder injection of breviscapinum and preparation process thereof |
| CN101757015B (en) * | 2010-01-15 | 2011-10-19 | 新乡医学院 | Composite of breviscapinum and panax notoginseng saponins Rg1 for treating pulmonary fibrosis and application thereof |
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