CN1824134A - Chinese medicinal preparation for treating liver disease and its preparation method - Google Patents
Chinese medicinal preparation for treating liver disease and its preparation method Download PDFInfo
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- CN1824134A CN1824134A CN 200510200815 CN200510200815A CN1824134A CN 1824134 A CN1824134 A CN 1824134A CN 200510200815 CN200510200815 CN 200510200815 CN 200510200815 A CN200510200815 A CN 200510200815A CN 1824134 A CN1824134 A CN 1824134A
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Abstract
A Chinese medicine for treating hepatism, especially the acute and chronic hepatitide is prepared from 7 Chinese-medicinal materials including giant knotweed rhizome, capejasmine fruit, phellodendron bark, red sage root, etc.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation for the treatment of hepatopathy and preparation method thereof, belong to the technical field of compound Chinese medicinal preparation.
Technical background:
Hepatopathy is a kind of commonly encountered diseases, and it is having a strong impact on the healthy of people.The people that the The World Health Organization (WHO) statistics whole world is infected by hepatitis B virus (HBV) is about 2,000,000,000, and wherein 300,000,000 is chronic carrier, and 25% is in a bad way among these patients, can finally die from liver cirrhosis and hepatocarcinoma; Chinese hepatitis B virus infection crowd account for population 10% on, about 1.2 hundred million people carry hepatitis B virus, the annual new cases that also have 50-100 ten thousand, quantity is quite surprising.The whole nation has 300,000 people to be devitalized by hepatopathy every year.This shows that hepatitis is big to human health risk, so person is arranged: " hepatitis is the killer who threatens fitness-for-all ", and existing treating the liver medicine is all based on Western medicine, in the treatment hepatopathy, can infringement be arranged to other organ of human body, to suffering from the patient of multiple disease, it is worthless taking the western medicine hepatopathy especially; Therefore, invent a kind of determined curative effect, safe ready, the little medicine that is used for the treatment of hepatopathy of side effect and seem very important.Prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; The patent application that the application number of submitting to as the applicant is 02134141.9, name is called " granule for treating hepatopathy " is developed for treating this disease, but, the extractum hygroscopicity of the product of discovery preparation is strong in the research that continues, and makes that granule storage for a long time is perishable, the quality instability of product; And the dosage form kind is abundant inadequately, is suitable for crowd's narrow range.Bioavailability, the medicine stability of conventional dosage forms are undesirable, and the problem that especially bioavailability of effective ingredient is not high is badly in need of solving; In view of such circumstances, dosage changing form has just become people's urgent problem.
Summary of the invention:
The objective of the invention is to: a kind of Chinese medicine preparation for the treatment of hepatopathy and preparation method thereof is provided, and this preparation comprises tablet, dispersible tablet, capsule, soft capsule, powder, injection, lyophilized injectable powder, pellet, drop pill or oral liquid etc.; The present invention is directed to prior art, the micropill that provides, dispersible tablet, disintegrative are good, and the bioavailability height is particularly suitable for infant, old people and swallow tablet or the inconvenient patient of capsule take; Soft capsule preparation provided by the invention forms drug blockage in soft gel coat, solved medicine and met damp and hot problem of unstable, can also cover adverse drug taste and abnormal smells from the patient, plays the effect that increases stability, improves bioavailability; Injection provided by the invention, lyophilized injectable powder are rapid-action, the bioavailability height.
The present invention constitutes like this: calculate according to composition by weight, it is with 130～370 parts of Rhizoma Polygoni Cuspidati, 100～300 parts of Fructus Gardeniaes, 100～300 parts of Cortex Phellodendris, 50～150 parts of Herba Reineckeae Carneaes, 50～150 parts of Rhizoma Belamcandaes, 200～600 parts of 100～300 parts of Radix Sophorae Flavescentiss and Radix Salviae Miltiorrhizaes, add appropriate amount of auxiliary materials again and be made into dispersible tablet, buccal tablet, chewable tablet, fuse, effervescent tablet, slow releasing tablet, controlled release tablet, enteric coatel tablets, capsule: soft capsule, slow releasing capsule, controlled release capsule, enteric coated capsule, paste, pill: drop pill, sugar pill, piller, micropill, concentrated pill, the watered pill, syrup, spray, oral solution, oral suspensions, Orally taken emulsion, powder, suppository, injection, lyophilized injectable powder, extractum, soft extract and other be the acceptable dosage form pharmaceutically.
Specifically, calculate according to composition by weight, it is with 400 parts of 250 parts of Rhizoma Polygoni Cuspidati, 200 parts of Fructus Gardeniaes, 200 parts of Cortex Phellodendris, 100 parts of Herba Reineckeae Carneaes, 100 parts of Rhizoma Belamcandaes, 200 parts of Radix Sophorae Flavescentiss and Radix Salviae Miltiorrhizaes, adds appropriate amount of auxiliary materials be made conventional tablet, dispersible tablet, hard capsule, soft capsule, powder, injection, lyophilized injectable powder, pellet, drop pill or oral liquid again.
Preparation method: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add appropriate amount of auxiliary materials then, adopt conventional method to make different preparations respectively.
Dispersible tablet prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Get 3～7% carboxymethyl starch sodium by weight, it is even to get 3/5 carboxymethyl starch sodium, starch 10～100 weight portions and above-mentioned thick paste, alcoholic solution with 3～5% polyvinylpyrrolidones is made binding agent, the wet grain of 40 order systems, granulate, add the residue 2/5 carboxymethyl starch sodium, add 0.5～1% magnesium stearate by weight, 1～5% micropowder silica gel is added in the granule that makes, mixing, tabletting, promptly.
Pellet prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Adding 10～50 weight portion starch, is 60～80% ethanol and 1.2～1.5% soybean oil system soft materials with concentration, the soft material that makes micropill mechanism ball, wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, 50～60 ℃ of drying and mouldings, cross 16～20 mesh sieves and select ball or spray drying, wet-milling granulation molding places mould to add the great achievement ball in the coating pan, medicated powder: water=1: 1.2～1.5, the coating pan rotating speed is 35～45r/min, capping selects ball, promptly.
Soft capsule prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get the PEG400 of 5～15 weight portions, the sorbitol and the above-mentioned fine powder mixing of 1～10 weight portion; Press medication amount: substrate amount=1: 1.2～1.5 add soybean oils, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100: 45: 100: 2, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 60～90 minutes, stirred 3～5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 65 ± 5 ℃ of gelatin box temperature controls, mould rotating speed 2.0～4.0 is rolled in 45 ± 5 ℃ of sprinkler body temperature controls, rubber thickness 0.7～0.8mm, 18～25 ℃ of indoor temperatures, relative humidity is less than 40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 2～5 hours of the typing of rolling, and 25 ± 5 ℃ of baking temperatures, dry relative humidity should be lower than 40%, and drying time is at 24～48 hours, promptly.
Drop pill prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get above-mentioned fine powder portion, two parts of Macrogol 4000s, polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, drip and in dimethicone, become ball, drip apart from 5cm, drip footpath 2.0mm/3.0mm mixes 80 ± 5 ℃ of ointment temperature, liquid coolant height 70 ± 5cm, promptly.
Tablet prepares like this: gets Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decocts with water 3 times, and the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the dextrin of starch, 5～20 weight portions of 10～100 weight portions, add 3～5% carboxymethyl starch sodium by weight, mixing, with 10～50% alcohol granulations, drying, granulate, add 1～3% carboxymethyl starch sodium by weight, 0.5～1% magnesium stearate, mixing, tabletting, coating, promptly.
Oral liquid prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add distilled water, add 2～5% aspartames by weight, sterilization, promptly.
Powder prepares like this: gets Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decocts with water 3 times, and the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the starch mix homogeneously of 10～50 weight portions, drying and crushing is sieved, divided dose, and packing, promptly.
Capsule prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add 10～50 weight portion starch, 5～20 weight portion calcium sulfate mix homogeneously, use alcohol granulation, filling, promptly.
Injection prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 10～50 weight portions, glucose 5～50 weight portion mix homogeneously add the injection water to 1000ml, and the adjusting liquid PH value is 2-7, filter, and embedding, sterilization, promptly.
Lyophilized injectable powder prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 5～50 weight portions, lactose 10～20 weight portions, mannitol 8～25 weight portion mix homogeneously, add the injection water to 1000ml, the adjusting liquid PH value is 2-7, filter, and embedding, lyophilization, promptly.
The applicant finds during dispersible tablet in development, and pharmacopeia regulation dispersible tablet must disintegrate fully in the 3min in 19 ℃～21 ℃ water, and suspension ability, bioavailability, dispersed homogeneous degree etc. are also had higher requirements.The diameter of micropill is less than 2.5mm, and class is in particle properties, the bioavailability height.
The applicant finds in the process of development drop pill, substrate polyethylene glycols commonly used is that esterification forms, be the surface-active water-soluble base of a kind of tool (fusing point is 46～51 ℃), dissolubility to insoluble drug is not good, we add S-40 change polyethylene glycols itself and do not have close ester structure and surface-active character, help the absorption of medicine, if but the consumption of S-40 is too high, and can cause product to draw moist enhancing.
The applicant finds in the process of development injection, because this Chinese medicine injection is a hypisotonic solution, intravenous injection can produce human body when the human body to stimulate, but also can influence the absorption of medicine, so we can also add osmotic pressure regulator when making intravenous fluid.Find after having compared glucose, sodium chloride, mannitol, sorbitol, xylitol: the drug safety that adds glucose and sodium chloride is best, but the medicine that adds sodium chloride has small amount of precipitate to produce, and its stability is poorer slightly than the medicine that adds glucose.The medicine stability that adds sorbitol, mannitol, xylitol is all better, but sorbitol and mannitol have diuresis, finds its influence that is absorbed with to medicine in the experimentation.The medicine that adds xylitol finds that in experimentation kidney is had infringement, and estimation is that xylitol changes fructose into, and fructose causes through the anerobic glycolysis metabolism.So among the present invention with glucose as saturating pressure regulator.
The applicant finds that the outward appearance after the herb liquid lyophilization of the present invention is bad in the process of development lyophilized injectable powder, so the applicant solves this problem by add excipient in medicinal liquid.By screening, the freeze-dried products color even that discovery makes as excipient with lactose and mannitol, constancy of volume, profile is better.
Compared with prior art, micropill disintegrative provided by the invention is good, the bioavailability height, and zest is little, is particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take; Medicine dispersible tablet provided by the invention, the mode of taking is more, can swallow, buccal and sucking take, it is convenient to use more than other oral solid formulation, simultaneously, this medicine is met water can rapid disintegrate form homodisperse aqueous solution in 3 minutes, solved the not high problem of effective ingredient bioavailability; Soft capsule of the present invention in soft gel coat, has solved drug blockage medicine and has met damp and hot problem of unstable, can also cover adverse drug taste and abnormal smells from the patient, plays the effect that increases stability, improves bioavailability; Tablet of the present invention, its molding is better, and disintegrative is good, the bioavailability height; Injection of the present invention and lyophilized injectable powder are rapid-action, the bioavailability height.
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 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 is high.
1. adjuvant screening
| Prescription | Carboxymethyl starch sodium | The alcoholic solution of polyvinylpyrrolidone (%) | Disintegration time/s | |
| Add | In add | |||
| 1 2 3 4 5 6 | 1/5 2/5 3/5 4/5 5/5 0 | 2/5 3/5 2/5 1/5 0 5/5 | 1 3 4 5 8 10 | 5.8 2.1 2.4 2.7 3.4 5.9 |
2. check disintegration
Adopting changes the basket method, and lift disintegration tester, tablet are got 6, observes the situation by screen cloth.Percent of pass height then disintegrative is good, more pleasant bulk absorption.
Disintegration (s)
| Group | 1 | 2 | 3 | 4 | 5 | 6 |
| 3 batches in 2 batches of tablets of the present invention of 1 batch of tablet of the present invention of tablet of the present invention | 12 14 11 | 13 12 9 | 13 13 10 | 11 10 11 | 11 12 13 | 13 12 14 |
The result shows, in add 3/5 carboxymethyl starch sodium and mixed powder mix homogeneously, the alcoholic solution of 3～5% polyvinylpyrrolidones is made binding agent, 40 order system material, granulate, remain 2/5 carboxymethyl starch sodium and be added in the particle that makes, tabletting, the dispersible tablet product that obtains is easy to disintegrate.
(2) pill moulding process
Research micropill diameter is less than 2.5mm, and class is in particle properties, the bioavailability height, and the applicant is when development product micropill of the present invention, and the micropill manufacturing technology and the adjuvant that adopt the applicant's screening to obtain make product be easy to disintegrate, and the bioavailability height is well-behaved.
1, extrudes-the spheronization pill
The system soft material: get mixed powder and starch, soybean oil and ethanol and make soft material with wet granulation process in right amount, make it to reach and hold agglomeratingly, that pinches can loose, standby.Research emphasis is the influence to pill of concentration of alcohol and soybean oil consumption, and experimental result sees Table.
| Concentration of alcohol is investigated | ||
| Tested number | Concentration of alcohol (%) | System soft material situation |
| 1 | 20～50 | Soft material easily bonds |
| 2 | 60～80 | Soft material is moderate |
| 3 | 85～95 | Soft material viscosity is not enough |
| The soybean oil consumption is investigated | ||
| Tested number | The soybean oil consumption | The pill situation |
| 1 | 60～80% ethanol, 0.5～1.0% soybean oil | Soft material viscosity is not enough, can't pill |
| 2 | 60～80% ethanol, 1.2～1.5% soybean oils | Soft material is moderate, suitable pill |
| 3 | 60～80% ethanol, 1.6～2.5% soybean oils | Soft material easily bonds, the pill difficulty |
The result as seen, it is more satisfactory to adopt 60～80% ethanol, 1.2～1.5% soybean oils to be that adhesive is granulated, otherwise is difficult to molding.
The soft material that makes is with micropill mechanism ball, and wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, and 50～60 ℃ of drying and mouldings are crossed 16～20 mesh sieves and selected ball.
2, general method for making pill
Because the extruding that the humidification of water and coating pan rotate makes medicated powder be bonded into ball.General when making ball, water spray is fast and to add medicated powder speed slow, causes that it is bonding closely the time that then prolongs into ball, makes dry back hard, is unfavorable for the infiltration of moisture and influences molten loosing and the absorbing of medicine.
| Numbering | Coating pan rotating speed (r/min) | The molten diffusing time (min) | Mouldability |
| 1 | 20～30 | 6.93 | Relatively poor |
| 2 | 35～45 | 7.12 | Better |
| 3 | 50～65 | 12.35 | Harder |
| 4 | 70～85 | 14.38 | Hard |
| 5 | 90～100 | 15.49 | Hard |
The result shows that it is optimum that the coating pan rotating speed is selected 35～45r/min for use.
(3) soft capsule Study on Forming
Soft capsule disintegrate in gastrointestinal tract is fast, and after softgel shell broke, medicine disperseed rapidly, so the drug release stripping is fast, produce effects is rapid, the bioavailability height; Semi-transparent soft capsule can protect medicine not to be subjected to the effect of oxygen, light in dampness and the air with packaging material preferably, thereby improves the stability of labile element: so capsular stability and moulding process are very crucial technology.
A. supplementary product kind and consumption are selected:
1. disperse medium (or claiming substrate) is selected fill material and substrate energy mix homogeneously, and under the prerequisite of unobstructed defeated material of energy and pelleting, reduces substrates quantity as far as possible.By test of many times, determine medication amount (g): be advisable in substrate amount (g)=1: 1.2～1.5, experimental result sees Table.
| Substrates quantity is investigated | |||
| Medication amount (g): substrate amount (g) quality of liquid medicine | 1: 0.5～1 viscosity is big, mobile poor | 1: 1.2～1.5 viscosity, flowability are all good | 1: 1.6～2.5 differences in viscosity are mobile big |
2. capsule shells prescription screening according to the form below ratio is prepared burden, put into the 500ml bottle,suction, 65 ± 5 ℃ of water-baths are dissolved, automatic stirringization glue, the while evacuation, about vacuum 0.04～0.095Mpa, insulation was placed 1～2 hour after 2～4 hours, filtered glue, get a part of glue and measure viscosity and other performance, part glue evenly is paved into skim (smear below earlier one deck liquid paraffin) on iron plate, be positioned over to observe the rubber performance next day and judge again, with the investigation result of each pointer by good to poorly using " +++" successively, " ++ ", "+",, " " expression the results are shown in Table.
| Rubber batching The selection result | ||||||
| Prescription | Viscosity flexibility (mpas) | Flexibility | Elasticity | Toughness | Characteristics | Overall merit |
| 1.∶∶ （ 100g∶35g∶100g ） 2.∶∶ （ 100g∶45g∶100g ） 3.∶∶ （ 100g∶55g∶100g ） 4.∶∶ （ 100g∶45g∶80g ） 5.∶∶ （ 100g∶45g∶120g ） 6.∶∶∶ （ 100g∶35g∶5g∶100g ） 7.∶∶∶ （ 100g∶33g∶10g∶100g ） 8.∶∶∶ （ 100g∶45g∶5g∶100g ） 9.∶∶∶ （ 100g∶45g∶10g∶100g ） 10.∶∶∶ （ 100g∶25g∶10g∶100g ） 11.∶∶∶ （ 100g∶35g∶20g∶100g ）。 | 3.62 3.32 3.59 3.73 3.11 3.43 3.46 3.52 3.47 3.62 3.57 | - + + ++ +++ - + ++ ++ + + | - ++ ++ ++ + + + + ++ + ++ | + +++ + + - ++ + + - ++ + | Crisp; Firmly tough, film forming good springiness good springiness, viscosity is big too softly toughly to be pierced through performance good tough soft tough to pierce through performance good | The fine general fine difference of difference is better fine better general better fine |
| 12.∶∶∶3.36 ( 100g∶55g∶5g∶90g ) 13.∶∶∶ ( 84g∶28g∶28g∶20g ) 14.∶∶∶3.57 ( 100g∶25g∶35g∶100g ) 15.∶∶∶3.51 ( 85g∶15g∶45g∶100g ) 16.∶∶∶∶3.39 ( 85g∶15g∶60g∶10g∶60g ) 17.∶∶∶∶3.63 ( 50g∶150g∶10g∶60g∶55g ) 18.∶∶∶∶3.52 ( 85g∶15g∶45g∶10g∶110g ) 19.∶∶∶∶3.38 ( 85g∶15g∶60g∶10g∶90g ) 20.∶∶∶∶3.35 ( 100g∶25g∶45g∶5g∶100g ) | ++ glue is too thick ,--+++++ | ++ can't change glue-++-++- | + + + ++ - + + + | 0.5mm following rubber is easily broken partially ash of the big following rubber poor flexibility of the partially grey 0.85mm of the crisp color color of the partially grey crisp 0.2～0.8mm rubber tearing strength of color | General than the fine difference of good job difference |
Through above screening, overall merit is considered the characteristics of fill material, and selecting prescription 2 is gelatin 100: glycerol 45: water 100.
3. opacifier is selected
The transparent adhesive tape softgel shell easily causes instability, so need to add a certain amount of opacifier.Select titanium dioxide (titanium dioxide) to make opacifier through investigation and can reach effective shaded effect, and steady quality, not with rubber cement and fill material generation chemical change.Its consumption is through investigating with gelatin: glycerol: water: titanium dioxide=100: 45: 100: 2 are advisable, and little to the rubber quality influence, the results are shown in Table.
| The opacifier consumption is selected | |||
| Usage ratio | The rubber transparency | Rubber cement viscosity (MpaS) | Overall merit |
| Gelatin: glycerine: water: titanium dioxide (100g: 45g: 100g: 0.5g) gelatin: glycerine: water: titanium dioxide (100g: 45g: 100g: 1g) gelatin: glycerine: water: titanium dioxide (100g: 45g: 100g: 2g) gelatin: glycerine: water: titanium dioxide (100g: 45g: 100g: 3g) | Translucent translucent opaque | 3.12 3.19 3.36 3.52 | The good inadequately viscosity of the not enough consumption of consumption is bigger |
Quality is more stable after adding opacifier in the capsule shells prescription.
B. molding technological condition is investigated
1. the particle degree is investigated
Mixed powder is pulverized, crossed 60 orders, 80 orders, 100 orders, 120 mesh sieves respectively, press mixed powder: substrate=1: 1.2 is even through the colloid mill mill, and observation mixing situation the results are shown in Table.
| The particle degree is investigated | ||||
| Granularity mixing situation | 60 orders can not mixing, high speed centrifugation (10000/min) 30min layering | 80 orders energy mixing, 30min is not stratified for high speed centrifugation (10000/min) | 100 orders energy mixing, 30min is not stratified for high speed centrifugation (10000/min) | 120 orders energy mixing, 30min is not stratified for high speed centrifugation (10000/min) |
As seen from the above table, pulverized 80 orders, it is 80 orders that just energy mixing, so selection is pulverized the order number.
2. fill material combined experiments chamber is got mixed powder and pulverized 80 mesh sieves, presses extractum: substrate=1: 1.2～1.5 add soybean oil, use the colloid mill mixing, and evacuation removes bubble, and is standby.
3. changing the glue investigation is gelatin by aforementioned preferred prescription: glycerol: water: titanium dioxide=100: 45: 100: 2 weigh batchings with different temperatures glue, the results are shown in Table.
| Changing the glue temperature investigates | ||
| Temperature (℃) | Change the glue time (H) | The rubber quality |
| 40～50 50～60 60～70 70～80 80～90 | 1～1.5 1.5～2 2～3 3～4 4～5 | General better harder carefully |
By the table prompting, it is the most suitable with 60～70 ℃ to change the glue temperature.So batchingization adhesive tape part is: weigh batching, in the inputizations glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 60～90 minutes, stirs 3～5 hours also the while evacuation except that bubble, treat sizing material even after blowing, incapsulate after the filtration in the sizing material bucket of machine.
4. pelleting: the sizing material bucket and the spice bucket of room temperature of insulation are delivered to the capsule machine top, be connected, debug pellet press with machine, 65 ± 5 ℃ of gelatin box temperature controls, mould rotating speed 2.0～4.0 is rolled in 45 ± 5 ℃ of sprinkler body temperature controls, rubber thickness 0.7 ± 0.8mm, 18～25 ℃ of indoor temperatures, relative humidity is less than 40%.Treat that it is 300 ± 25mg/ grain that ball content loading amount is regulated in pellet press debugging back.Survey loading amount once every half an hour in the pelleting process.
5. dry: the dry soft capsule through pellet press extrusions of typing is in conveyer belt is delivered to rotating cage, and rotating cage is blown a cold wind over while rotating, rotates about 2～5 hours of the drying of finalizing the design.Tray dried: the soft gelatin capsule of cold air drying is contained in clean rustless steel charging tray splendid attire in rotating cage, move to about 25 ± 5 ℃ of temperature, airing is 24～48 hours in the hothouse of relative humidity below 40%, and constantly stirs, and surveys capsule moisture and is being dry suiting below 10%.The drying lime light: the dry typing drying of rolling that adopts combined with two steps of tray dried, and the typing of rolling is dry is advisable with two hours through investigation, and overlong time is then rough; Baking temperature is advisable about investigating with 25 ± 5 ℃, and it is long that it's low drying time is past temperature, though increase in temperature can shorten drying time, easily produces Testudinis to capsule surface and splits; Dry relative humidity should be lower than 40% through investigating, otherwise is difficult for dry; Got final product below 10% with control moisture drying time about 24～48 hours.
(4) drop pill moulding process
1. the screening of substrate
| The fusion situation of substrate and principal agent relatively | ||||||
| The prescription number | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 |
| Medicine (g) Macrogol 4000 (g) polyethylene glycol 6000 (g) S-40 | 10 30 - - | 10 20 - - | 10 20 - 10 | 10 20 20 10 | 10 10 30 - | 10 10 5 - |
| The fusion situation of principal agent and substrate | Principal agent can merge with substrate but system does not have flowability | Principal agent can merge the system good fluidity with substrate | Medicine can to merge the system flowability fine with substrate | Principal agent and substrate merge relatively poor but system does not have flowability | Principal agent can to merge the system flowability relatively poor with substrate | |
| The drop pill outward appearance | - | Roundness is poor | Smooth | Smooth | - | Roundness is poor |
| Drop pill hardness | - - | Hangover hardness is little | The good hardness of roundness is better | It is whole that to have spent hardness better | Hangover hardness is better | |
| The different dissolve scattered time limit of the ball method of double differences (min) | - - | 20％ 7～8 | 8.0％ 4～5 | 12.5％ 9～10 | - - | 20％ 6～8 |
The result shows, the drop pill stripping that composite interstitial substance makes is very fast, because the esterification of polyethylene glycols substrate forms, it is a kind of surface-active water-soluble base (fusing point is 46～51 ℃) that has, S-40 has changed polyethylene glycols itself and has not had close ester structure and surface-active character, improve the dissolubility of insoluble drug, help the absorption of medicine.
2. drip distance, drip selection fast, temperature
The interior external diameter of drip is fixed as 2.0mm～3.0mm.Estimate pointer: the heavy qualification rate of ball is by mass discrepancy requirement of Pharmacopoeia of the People's Republic of China version in 2005: meet ± 15% within.
| Group | Temperature/℃ | Drip distance/cm | Liquid coolant height/cm | Heavy qualification rate/the % of ball |
| 1 2 3 4 5 6 7 | 90 90 90 85 80 80 75 | 3 5 8 4 5 8 4 | 50 60 65 60 70 50 70 | 78.3 89.4 82.1 90.7 95.2 90.0 91.7 |
| 8 9 | 70 85 | 5 6 | 50 65 | 89.1 92.2 |
The result shows, the optimum condition of preparation drop pill of the present invention: drip to become ball in dimethicone, drip apart from 5cm, drip footpath 2.0mm/3.0mm mixes 80 ± 5 ℃ of ointment temperature, liquid coolant height 70 ± 5cm.
(5) lyophilized injectable powder moulding process
The selection of excipient
Excipient title products appearance
Glucose ten glycine have foaming and volumetric expansion
The sucrose volume-diminished
The lactose volume-diminished
The mannitol volume-diminished
The inositol irregular colour is even
The trehalose irregular colour is even
Lactose+mannitol color even, constancy of volume, external form is better
The result shows the freeze-dried products color even that makes as excipient with lactose and mannitol, constancy of volume, and profile is better.
Experimental example 2: pharmacological experiment study
Preparation of the present invention is to the influence of the acute and chronic hepatic injury of animal
1, the present invention is to CCL
4The induced mice acute liver damage
[1]Influence.
50 of Kunming mouses are divided into 5 groups at random; Be respectively matched group, model group, bifendate 0.3g/kg group, 3g/kg of the present invention and 1g/kg group.Each administration group according to dosage every day gastric infusion once, matched group and model group wait the normal saline of capacity simultaneously, continuous 6 days, after the administration in the morning on the 5th 1 hour, model group and each administration group mouse subcutaneous injection 0.5%CCL
40.1ml/kg (10ml/kg) capacity normal saline such as matched group subcutaneous injection, afternoon on the same day, reinforcement was administered once, behind the fasting 12h, 1h after administration in the morning on the 6th, broken end is got blood, centrifugal (10,000g * 5min), measure SGPT and SGOT unit of activity in the serum with reitman-frankel method.
The present invention is to CCL
4Due to acute liver damage mice serum transaminase's influence (X ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | Serum transaminase unit of activity (u/100ml serum) | |
| SGPT | SGOT | |||
| Matched group | - | 10 | 85.30±5.44** | 128.9±47.23*** |
| Model group | 0.5％CCL 410ml/kg | 10 | 178.86±76.66 | 243.16±45.68 |
| The present invention 1 | 3+CCL 4 | 10 | 97.9±17.46** | 185.32±49.15* |
| The present invention 2 | 1+CCL 4 | 10 | 103.3±27.19* | 144.75±22.97*** |
| Bifendate | 0.3+CCL 4 | 10 | 107.09±20.84** | 173.2±73.55* |
*, * * and * * * compare P＜0.05, P＜0.01 and P＜0.001 with model group
The result shows, mouse subcutaneous injection CCL
4Back 24h, serum SGPT and SGOT vigor are apparently higher than matched group.Bifendate group and 3g/kg of the present invention and 1g/kg group mice serum SGTP and SGOT vigor all significantly are lower than model group, (P＜0.05, P＜0.01 and P＜0.001).There is not marked difference (P＞0.05) between the present invention and the bifendate group.
2, the present invention is to CCL
4Due to the influence of rat chronic hepatic injury
Get 106 of male rats, body weight 130～140g is divided into 5 groups at random, matched group (20), model group (22), bifendate group 150mg/kg (20).
Each administration group according to dosage every day gastric infusion once, continuous three months.In administration the 5th day subcutaneous injection CCL weekly
40.2ml/100g, CCL
4Concentration is followed successively by 5%, 10%, 20% and 30%, and per three weeks increase progressively a concentration.Last injection CCL
4Behind the 48h (fasting 12h), each organizes 8 rats of sacrificed by decapitation, gets liver and weighs, and calculates liver index (hepatic tissue weight/body weight * 100%).The residue rat adopts the eye socket rear vein beard to get blood.All blood sample are centrifugal, and (10,000g * 5min) measures serum SGPT and SGOT vigor with reitman-frankel method; Measure The Total albumen content with biuret method; Measure serum albumin levels with the bromocresol green method; Measure the content of THP in the serum with alkali hydrolysis method.Then remain rat and continue in accordance with regulations once (each group CCL that all stops using of dosage gastric infusion every day
4), totally 14 days, fasting was after 12 hours, and broken end is got blood and is got liver.Measure the content of SGPT, SGOT in the serum by above-mentioned same procedure
[3]
The present invention is to CCL
2Due to the influence of chronic hepatic injury rats death rate
| Group | Dosage (g/kg) | Number of animals (only) | Death toll (only) | Mortality rate (only) |
| Matched group | - | 20 | 1 | 5 + |
| Model group | CCL 4 | 22 | 6 | 27.3 |
| The present invention 1 | 1+CCL 4 | 22 | 3 | 13.6 |
| The present invention 2 | 0.3+CCL 4 | 22 | 1 | 4.5 + |
| Bifendate | 0.15+CCL 4 | 20 | 3 | 15 |
* compare P＜0.05 (X with model group
2Check)
The result shows that rat is injected CCL continuously
4During three months; the part animal dead; the model group disability rate is 27.3%; with normal group significant difference (P＜0.05) is arranged relatively; the mortality rate of 1g/kg of the present invention, 0.3g/kg and bifendate 0.15g/kg group is respectively 13.6%, 4.5% and 20%; the result shows that each administration group can make the animal dead rate descend, and wherein the 0.3g/kg group has remarkable protective effect (P＜0.05).
The present invention contrasts CCL
4Due to chronic hepatic injury rat blood serum transaminase's influence
| Group | Dosage (g/kg) | Serum transaminase unit of activity (μ/100ml serum) CCL that stops using 4Continue treatment time X ± SD | |||
| 2d | 14d | ||||
| SGPT | SGOT | SGTP | SGOT | ||
| Matched group | 269.6±36.7*** | 484.1±76.5(17)*** | 234.4±24.3*** | 377.9±40.0(9)*** | |
| Model group | CCL 4 | 484.7±216.5 | 635.9±161.4(17) | 309.1±44.6 | 345.9±96.7(8) |
| The present invention 1 | CCL 4 | 484.7±216.5 | 635.9±161.4(17)*** | 309.1±44.6**△△ | 345.9±96.7(8) |
| The present invention 2 | 0.3+CCL 4 | 384.2±128.0*** | 615.0±142.0(19)*** | 244.1±23.3*** | 295.2±26.5(11)** |
| Bifendate | 0.15+CCL 4 | 538.8±241.9* | 673.3±196.0(14***) | 236.5±23.5*** | 339.5±36.8(8)*** |
* and * * * and model group relatively P＜0.02, P＜0.001 △ △ and bifendate group compare P＜0.01
The result shows, rat continuous subcutaneous injection CCL
4After three months, serum SGPT and SGOT vigor significantly strengthen, and compare P＜0.001 with matched group.Each dosage group rat blood serum transaminase vigor of the present invention significantly reduces, and compares P＜0.001 and P＜0.01 with model group.There was no significant difference between each dosage group of the present invention.Bifendate group rat blood serum transfer ammonia enzyme activity also significantly is lower than model group (P＜0.05 and P＜0.001), there was no significant difference between of the present invention group and the bifendate group.Stop to inject CCL
4Continue medication after 14 days, model group rat blood serum transaminase vigor recovers to some extent, but still be significantly higher than normal control group (P＜0.001), each dosage group of the present invention and bifendate group rat blood serum transaminase vigor all significantly are lower than model group (P＜0.01 and P＜0.001), and there was no significant difference between the matched group, also there was no significant difference between the present invention and the bifendate group.
Main pharmaceutical research result shows that the present invention has the effect of prevention and the acute and chronic chronic persistent hepatitis of treatment animal, can obviously reduce CCL
4The mice serum transaminase who causes with D-CalN increases, and effect of reducing enzyme levels is similar to the 0.3g/kg bifendate, illustrates that this herbal mixture has the better protect effect to acute and chronic liver injury.
Experimental example 3: bioavailability relatively
Get 1 of Beagle Canis familiaris L., body weight 14.5kg, fasting overnight (can't help water), next day gastric infusion.Get each 2ml of blood respectively at 0,0.51,2,3,4,5,6,7,8, place behind the 10h centrifugally, precision is measured serum 0.5ml.
Set up responsive fast high performance liquid chromatography-uv detection method, adopt external standard method.
Method: with high performance liquid chromatography (HPLC), being detached dowel with Nova-pak C18 chromatographic column, is mobile phase with methanol-water (25: 75), detects at 240nm wavelength place.
Low speed centrifuge (Beijing medical apparatus factory), XW-80A vortex mixer (Instrument Factory, Shanghai Medical Science Univ.).Blood sample is put the anticoagulant heparin pipe, the centrifugal 5min of 3000r/min, and separated plasma is put-30 ℃ and is saved to analysis.High performance liquid chromatography is furnished with 600 pumps, 996 diode array detectors, 2010 data processing softwares; The U6K injector, M490 variable-wavelenght detector and 810 chromatographic data treating stations are formed (Waters, the U.S.).(46mm * 250mm), mobile phase is methanol-0.5% glacial acetic acid (80: 20) to the HypersilBDSC1 chromatographic column, and flow velocity is 1.0ml/min, and the detection wavelength is 430nm.
Dog plasma jasminoidin concentration change
(N=6) time/h blood plasma jasminoidin concentration/(mgL
-1)
| Dispersible tablet of the present invention | Drop pill of the present invention | Micropill of the present invention | Soft capsule of the present invention | The contrast granule | Capsule of the present invention | |
| 0 0.25 0.50 0.85 1.00 2.00 3.00 4.00 6.00 8.00 | - 2.41±0.23 3.65±0.31 2.31±0.46 2.68±0.77 2.35±0.24 2.07±0.36 1.87±0.38 1.41±0.28 0.24±0.25 | - 2.61±0.24 3.55±0.66 2.42±0.81 2.70±0.56 2.58±0.53 2.23±0.30 1.78±0.27 1.48±0.21 0.18±0.13 | - 2.64±0.23 3.58±1.24 2.37±0.44 2.66±0.67 2.37±0.34 2.15±0.22 1.84±0.37 1.43±0.28 1.27±0.30 | - 2.72±0.38 3.37±1.22 2.50±0.30 2.74±0.56 2.38±0.33 2.05±0.28 1.52±0.22 1.47±0.35 0.27±0.23 | - 2.68±0.23 3.62±1.14 2.23±0.45 2.67±0.57 2.32±0.35 2.18±0.33 1.85±0.30 1.33±0.27 1.26±0.24 | - 1.74±0.28 2.04±0.43 2.02±0.68 2.34±0.35 2.07±0.53 1.71±0.31 1.37±0.14 1.24±0.13 0.17±0.25 |
The result shows that the bioavailability of product of the present invention is not less than the granule of prior art for preparing, but the invention of multiple dosage form more helps the selection of patient to the use of medicine.
Concrete embodiment:
Embodiments of the invention 1: the preparation 1 of dispersible tablet
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 100g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Get 3% carboxymethyl starch sodium by weight, it is even to get 3/5 carboxymethyl starch sodium, starch 10g and above-mentioned thick paste, alcoholic solution with 3% polyvinylpyrrolidone is made binding agent, the wet grain of 40 order systems, granulate, add residue 2/5 carboxymethyl starch sodium, 0.5% magnesium stearate by weight, 1% micropowder silica gel is added in the granule that makes, mixing, tabletting, promptly.This product is oral, and 3 times on the one, each 2.
Embodiments of the invention 2: the preparation 2 of dispersible tablet
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 100g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 150g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Get 7% carboxymethyl starch sodium by weight, it is even to get 3/5 carboxymethyl starch sodium, starch 100g and above-mentioned thick paste, alcoholic solution with 5% polyvinylpyrrolidone is made binding agent, the wet grain of 40 order systems, granulate, add residue 2/5 carboxymethyl starch sodium, 1% magnesium stearate by weight, 5% micropowder silica gel is added in the granule that makes, mixing, tabletting, promptly.
Embodiments of the invention 3: the preparation 3 of dispersible tablet
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 100g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Get 5% carboxymethyl starch sodium by weight, it is even to get 3/5 carboxymethyl starch sodium, starch 50g and above-mentioned thick paste, alcoholic solution with 4% polyvinylpyrrolidone is made binding agent, the wet grain of 40 order systems, granulate, add residue 2/5 carboxymethyl starch sodium, 0.75% magnesium stearate by weight, 3% micropowder silica gel is added in the granule that makes, mixing, tabletting, promptly.
Embodiments of the invention 4: the preparation 1 of pellet
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 200g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 150g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add 10g starch, with 60% ethanol and 1.2% soybean oil system soft material, the soft material that makes is with micropill mechanism ball, and wet feed pushed the 0.8mm sieve aperture, and the wet grain cut-out of strip is round as a ball, 50～60 ℃ of drying and mouldings, 16 mesh sieves select ball, promptly.
Embodiments of the invention 5: the preparation 2 of pellet
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 300g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add 50g starch, with 80% ethanol and 1.5% soybean oil system soft material, the soft material that makes is with micropill mechanism ball, and wet feed pushed the 0.8mm sieve aperture, and the wet grain cut-out of strip is round as a ball, 50～60 ℃ of drying and mouldings, 20 mesh sieves select ball, promptly.
Embodiments of the invention 6: the preparation 3 of pellet
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 300g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add 30g starch, with 70% ethanol and 1.3% soybean oil system soft material, the soft material that makes is with micropill mechanism ball, and wet feed pushed the 0.8mm sieve aperture, and the wet grain cut-out of strip is round as a ball, 50～60 ℃ of drying and mouldings, 18 mesh sieves select ball, promptly.
Embodiments of the invention 7: the preparation 1 of soft capsule
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 200g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get sorbitol and the above-mentioned fine powder of PEG400, the 1g of 5g, mixing; Press medication amount: substrate amount=1: 1.2 adding soybean oil, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100: 45: 100: 2, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 65 ℃ gradually after 60 minutes, stirred 3 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 45 ℃ of sprinkler body temperature controls, rubber thickness 0.7mm, 18～25 ℃ of indoor temperatures, relative humidity is less than 40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 2 hours of the typing of rolling, and 25 ℃ of baking temperatures, dry relative humidity should be lower than 40%, 24 hours drying times, promptly.This product is oral, and 3 times on the one, each 2.
Embodiments of the invention 8; The preparation 2 of soft capsule
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 200g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get sorbitol and the above-mentioned fine powder of PEG400, the 10g of 15g, mixing; Press medication amount: substrate amount=1: 1.5 adding soybean oil, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100: 45: 100: 2, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 70 ℃ gradually after 90 minutes, stirred 5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 70 ℃ of gelatin box temperature controls, mould rotating speed 4.0 is rolled in 50 ℃ of sprinkler body temperature controls, rubber thickness 0.8mm, 18～25 ℃ of indoor temperatures, relative humidity is less than 40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 5 hours of the typing of rolling, and 30 ℃ of baking temperatures, dry relative humidity should be lower than 40%, 48 hours drying times, promptly.
Embodiments of the invention 9: the preparation 3 of soft capsule
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 100g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get sorbitol and the above-mentioned fine powder of PEG400, the 5g of 10g, mixing; Press medication amount: substrate amount=1: 1.4 adding soybean oil, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100: 45: 100: 2, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 60 ℃ gradually after 75 minutes, stirred 4 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 60 ℃ of gelatin box temperature controls, mould rotating speed 3.0 is rolled in 40 ℃ of sprinkler body temperature controls, rubber thickness 0.75mm, 18～25 ℃ of indoor temperatures, relative humidity is less than 40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 3 hours of the typing of rolling, and 20 ℃ of baking temperatures, dry relative humidity should be lower than 40%, 36 hours drying times, promptly.
Embodiments of the invention 10: the preparation 1 of drop pill
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 300g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get above-mentioned fine powder portion, two parts of Macrogol 4000s, polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, drip and in dimethicone, become ball, drip apart from 5cm, drip footpath 2.0mm/3.0mm mixes 80 ℃ of ointment temperature, liquid coolant height 70cm, promptly.This product is oral, and 3 times on the one, each 2.
Embodiments of the invention 11: the preparation 2 of drop pill
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 100g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get above-mentioned fine powder portion, two parts of Macrogol 4000s, polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, drip and in dimethicone, become ball, drip apart from 5cm, drip footpath 2..0mm/3.0mm mixes 85 ℃ of ointment temperature, liquid coolant height 75cm, promptly.
Embodiments of the invention 12: the preparation 3 of drop pill
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 100g, Cortex Phellodendri 200g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get above-mentioned fine powder portion, two parts of Macrogol 4000s, polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, drip and in dimethicone, become ball, drip apart from 5cm, drip footpath 2.0mm/3.0mm mixes 75 ℃ of ointment temperature, liquid coolant height 65cm, promptly.
Embodiments of the invention 13: the preparation 1 of tablet
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 300g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 150g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the dextrin of starch, the 5g of 10g, add 3% carboxymethyl starch sodium by weight, mixing is used 10% alcohol granulation, drying, and granulate adds 1% carboxymethyl starch sodium by weight, 0.5% magnesium stearate, mixing, tabletting, coating, promptly.
Embodiments of the invention 14: the preparation 2 of tablet
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 100g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the dextrin of starch, the 20g of 100g, add 5% carboxymethyl starch sodium by weight, mixing is used 50% alcohol granulation, drying, and granulate adds 3% carboxymethyl starch sodium by weight, 1% magnesium stearate, mixing, tabletting, coating, promptly.
Embodiments of the invention 15: the preparation 3 of tablet
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 200g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the dextrin of starch, the 10g of 50g, add 4% carboxymethyl starch sodium by weight, mixing is used 30% alcohol granulation, drying, and granulate adds 2% carboxymethyl starch sodium by weight, 0.75% magnesium stearate, mixing, tabletting, coating, promptly.
Embodiments of the invention 16: the preparation 1 of oral liquid
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 100g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add distilled water, add 2% aspartame by weight, sterilization, promptly.
Embodiments of the invention 17: the preparation 2 of oral liquid
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 100g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add distilled water, add 5% aspartame by weight, sterilization, promptly.
Embodiments of the invention 18: the preparation 3 of oral liquid
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 300g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 150g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add distilled water, add 3% aspartame by weight, sterilization, promptly.
Embodiments of the invention 19: the preparation 1 of powder
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 100g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The starch that adds 10g, mixing, drying and crushing is sieved, divided dose, packing, promptly.
Embodiments of the invention 20: the preparation 2 of powder
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 300g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 400g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The starch that adds 50g, mixing, drying and crushing is sieved, divided dose, packing, promptly.
Embodiments of the invention 21: the preparation 3 of powder
Get Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 100g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 400g seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃: the starch that adds 30g, mixing, drying and crushing is sieved, divided dose, packing, promptly.
Embodiments of the invention 22: the preparation 1 of capsule
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 100g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the starch of 10g, the calcium sulfate mix homogeneously of 5g, use alcohol granulation, filling, promptly.
Embodiments of the invention 23: the preparation 2 of capsule
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 300g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the starch of 50g, the calcium sulfate mix homogeneously of 20g, use alcohol granulation, filling, promptly.
Embodiments of the invention 24: the preparation 3 of capsule
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 200g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the starch of 30g, the calcium sulfate mix homogeneously of 10g, use alcohol granulation, filling, promptly.
Embodiments of the invention 25: the preparation 1 of injection
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 100g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 100g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 10g, glucose 5g mix homogeneously adds the injection water to 1000ml, and the adjusting liquid PH value is 2-7, filter, and embedding, sterilization, promptly.
Embodiments of the invention 26: the preparation 2 of injection
Getting Rhizoma Polygoni Cuspidati 250g, Fructus Gardeniae 200g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 100g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 200g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 50g, glucose 50g mix homogeneously adds the injection water to 1000ml, and the adjusting liquid PH value is 2-7, filter, and embedding, sterilization, promptly.
Embodiments of the invention 27: the preparation 3 of injection
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 300g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 200g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 30g, glucose 25g mix homogeneously adds the injection water to 1000ml, and the adjusting liquid PH value is 2-7, filter, and embedding, sterilization, promptly.
Embodiments of the invention 28: the preparation 1 of lyophilized injectable powder
Getting Rhizoma Polygoni Cuspidati 130g, Fructus Gardeniae 100g, Cortex Phellodendri 100g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 100g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 5g, lactose 10g, mannitol 8g mix homogeneously, add the injection water to 1000ml, the adjusting liquid PH value is 2-7, filter, and embedding, lyophilization, promptly.
Embodiments of the invention 29: the preparation 2 of lyophilized injectable powder
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 100g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 50g, Rhizoma Belamcandae 50g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 50g, lactose 20g, mannitol 25g mix homogeneously, add the injection water to 1000ml, the adjusting liquid PH value is 2-7, filter, and embedding, lyophilization, promptly.
Embodiments of the invention 30: the preparation 3 of lyophilized injectable powder
Getting Rhizoma Polygoni Cuspidati 370g, Fructus Gardeniae 300g, Cortex Phellodendri 300g, Herba Reineckeae Carneae 150g, Rhizoma Belamcandae 150g, Radix Sophorae Flavescentis 300g and Radix Salviae Miltiorrhizae 600g seven flavor medicine decocts with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 25g, lactose 15g, mannitol 16g mix homogeneously, add the injection water to 1000ml, the adjusting liquid PH value is 2-7, filter, and embedding, lyophilization, promptly.
Claims (13)
1. Chinese medicine preparation for the treatment of hepatopathy, it is characterized in that: calculate according to composition by weight, it is with 130～370 parts of Rhizoma Polygoni Cuspidati, 100～300 parts of Fructus Gardeniaes, 100～300 parts of Cortex Phellodendris, 50～150 parts of Herba Reineckeae Carneaes, 50～150 parts of Rhizoma Belamcandaes, 200～600 parts of 100～300 parts of Radix Sophorae Flavescentiss and Radix Salviae Miltiorrhizaes, add appropriate amount of auxiliary materials again and be made into dispersible tablet, buccal tablet, chewable tablet, fuse, effervescent tablet, slow releasing tablet, controlled release tablet, enteric coatel tablets, capsule: soft capsule, slow releasing capsule, controlled release capsule, enteric coated capsule, paste, pill: drop pill, sugar pill, piller, micropill, concentrated pill, the watered pill, syrup, spray, oral solution, oral suspensions, Orally taken emulsion, powder, suppository, injection, lyophilized injectable powder, extractum, soft extract and other be the acceptable dosage form pharmaceutically.
2. according to the Chinese medicine preparation of the described treatment hepatopathy of claim 1, it is characterized in that: calculate according to composition by weight, it is with 400 parts of 250 parts of Rhizoma Polygoni Cuspidati, 200 parts of Fructus Gardeniaes, 200 parts of Cortex Phellodendris, 100 parts of Herba Reineckeae Carneaes, 100 parts of Rhizoma Belamcandaes, 200 parts of Radix Sophorae Flavescentiss and Radix Salviae Miltiorrhizaes, adds appropriate amount of auxiliary materials be made conventional tablet, dispersible tablet, hard capsule, soft capsule, powder, injection, lyophilized injectable powder, pellet, drop pill or oral liquid again.
3. the preparation method of the Chinese medicine preparation of treatment hepatopathy as claimed in claim 1 or 2, it is characterized in that: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add appropriate amount of auxiliary materials then, adopt conventional method to make different preparations respectively.
4. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the dispersible tablet in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Get 3～7% carboxymethyl starch sodium by weight, it is even to get 3/5 carboxymethyl starch sodium, starch 10～100 weight portions and above-mentioned thick paste, alcoholic solution with 3～5% polyvinylpyrrolidones is made binding agent, the wet grain of 40 order systems, granulate, add the residue 2/5 carboxymethyl starch sodium, add 0.5～1% magnesium stearate by weight, 1～5% micropowder silica gel is added in the granule that makes, mixing, tabletting, promptly.
5. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the pellet in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Adding 10～50 weight portion starch, is 60～80% ethanol and 1.2～1.5% soybean oil system soft materials with concentration, the soft material that makes micropill mechanism ball, wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, 50～60 ℃ of drying and mouldings, cross 16～20 mesh sieves and select ball or spray drying, wet-milling granulation molding places mould to add the great achievement ball in the coating pan, medicated powder: water=1: 1.2～1.5, the coating pan rotating speed is 35～45r/min, capping selects ball, promptly.
6. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the soft capsule in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get the PEG400 of 5～15 weight portions, the sorbitol and the above-mentioned fine powder mixing of 1～10 weight portion; Press medication amount: substrate amount=1: 1.2～1.5 add soybean oils, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100: 45: 100: 2, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 60～90 minutes, stirred 3～5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 65 ± 5 ℃ of gelatin box temperature controls, mould rotating speed 2.0～4.0 is rolled in 45 ± 5 ℃ of sprinkler body temperature controls, rubber thickness 0.7～0.8mm, 18～25 ℃ of indoor temperatures, relative humidity is less than 40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 2～5 hours of the typing of rolling, and 25 ± 5 ℃ of baking temperatures, dry relative humidity should be lower than 40%, and drying time is at 24～48 hours, promptly.
7. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the drop pill in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; The thick paste crushed after being dried is become fine powder, get above-mentioned fine powder portion, two parts of Macrogol 4000s, polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, drip and in dimethicone, become ball, drip apart from 5cm, drip footpath 2.0mm/3.0mm mixes 80 ± 5 ℃ of ointment temperature, liquid coolant height 70 ± 5cm, promptly.
8. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the tablet in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the dextrin of starch, 5～20 weight portions of 10～100 weight portions, add 3～5% carboxymethyl starch sodium by weight, mixing, with 10～50% alcohol granulations, drying, granulate, add 1～3% carboxymethyl starch sodium by weight, 0.5～1% magnesium stearate, mixing, tabletting, coating, promptly.
9. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the oral liquid in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add distilled water, add 2～5% aspartames by weight, sterilization, promptly.
10. according to the preparation method of the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the powder in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add the starch mix homogeneously of 10～50 weight portions, drying and crushing is sieved, divided dose, and packing, promptly.
11. preparation method according to the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the capsule in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add 10～50 weight portion starch, 5～20 weight portion calcium sulfate mix homogeneously, use alcohol granulation, filling, promptly.
12. preparation method according to the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the injection in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 10～50 weight portions, glucose 5～50 weight portion mix homogeneously add the injection water to 1000ml, and the adjusting liquid PH value is 2-7, filter, and embedding, sterilization, promptly.
13. preparation method according to the Chinese medicine preparation of the described treatment hepatopathy of claim 3, it is characterized in that: the lyophilized injectable powder in the described preparation prepares like this: get Rhizoma Polygoni Cuspidati, Fructus Gardeniae, Cortex Phellodendri, Herba Reineckeae Carneae, Rhizoma Belamcandae, Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae seven flavor medicine and decoct with water 3 times, the 1st time 1.5 hours, the 2nd time 1 hour, the 3rd time 1 hour, merge 3 times decoction liquor, filter, the survey relative density was 1.22～1.25 thick paste when filtrate was concentrated into 25 ℃; Add glycerol 5～50 weight portions, lactose 10～20 weight portions, mannitol 8～25 weight portion mix homogeneously, add the injection water to 1000ml, the adjusting liquid PH value is 2-7, filter, and embedding, lyophilization, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510200815 CN1824134A (en) | 2005-12-16 | 2005-12-16 | Chinese medicinal preparation for treating liver disease and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200510200815 CN1824134A (en) | 2005-12-16 | 2005-12-16 | Chinese medicinal preparation for treating liver disease and its preparation method |
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| CN1824134A true CN1824134A (en) | 2006-08-30 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108697750A (en) * | 2015-10-01 | 2018-10-23 | 光动力公司 | Novel Gentrin Knotweed P.E and their purposes as light power inactivator |
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2005
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108697750A (en) * | 2015-10-01 | 2018-10-23 | 光动力公司 | Novel Gentrin Knotweed P.E and their purposes as light power inactivator |
| US11660323B2 (en) | 2015-10-01 | 2023-05-30 | PhotoDynamic Inc. | Use of Polygonum cuspidatum extracts as photodynamic antimicrobial agents |
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