CN100431527C - Chinese medicine bolus preparing process - Google Patents
Chinese medicine bolus preparing process Download PDFInfo
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- CN100431527C CN100431527C CNB2006100430448A CN200610043044A CN100431527C CN 100431527 C CN100431527 C CN 100431527C CN B2006100430448 A CNB2006100430448 A CN B2006100430448A CN 200610043044 A CN200610043044 A CN 200610043044A CN 100431527 C CN100431527 C CN 100431527C
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Abstract
The Chinese medicine bolus preparing process includes the following steps: crushing the Chinese medicinal materials; mixing 10-99 % of the medicine material powder and adhesive in 0.01-60 % of medicine material weight, pelletizing the mixture, drying and making ball in spherical mold; moistening the ball with adhesive in 0.01-30 % of the ball weight, adhering the other medicine powder homogeneously onto the surface of the ball to form the bolus, and drying or coating the bolus. Thus prepared Chinese medicine bolus has high leaching degree, short dissolving time, high bioavailability, high absorption and quick acting.
Description
Technical field
The present invention relates to a kind of preparation technology of Chinese medicine preparation, particularly a kind of preparation technology of medicine pill.
Background technology
Pill is a kind of important Chinese medicine dosage form.Preparation pill traditional handicraft is that the prescription medical material is ground into 80-100 purpose fine powder; The part fine powder is added in the general ball pot, the piller that adds the certain particle diameter of the general one-tenth of water, dry back is as mould, again mould is added in the general ball pot, all the other medicated powder evenly are sprinkling upon the general gradually pill of making on the mould, adopt the oven for drying pill of hot air circulation, adopt and select the ball machine to select prescribed level, ball pill heavily.The defective of tradition pill: the mould size of 1 general ball is inhomogeneous, influences shape, the outward appearance of finished product pill, and ball is heavy can not to meet the pharmacopeia requirement; 3, production efficiency is lower, per hour is no more than 10,000; Batch production cycle is long, generally need be at 10-15 days; 4, because of the general system of pill, the pill dissolve scattered time limit instability 5 that the different process personnel produce, the microbial limit of pill are difficult for meeting the pharmacopeia requirement; 6, poor, the coatings of the fineness of finished product pill has obscission, and the ball method of double differences is different big.
Summary of the invention
The purpose of this invention is to provide a kind of crude drug composition stripping height, dissolve scattered time limit is short, bioavailability is high, good absorbing, curative effect is fast, the preparation method of medicine pill with short production cycle, that efficient is high.
Purpose of the present invention can realize by following measure:
A kind of preparation method of medicine pill, be that the medical material of will filling a prescription earlier is ground into granularity and is not more than 10 purpose medicated powder, get 10～99% medicated powder, the binding agent that adds raw medicinal material total amount 0.01～60%, be prepared into granularity and be not more than 10 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medicated powder, and is dry or with gained pill pack film-coat promptly.
A kind of preparation method of medicine pill, be that the medical material of will filling a prescription earlier is ground into granularity and is not more than 10 purpose medicated powder, get 10～99% medicated powder, the binding agent that adds raw medicinal material total amount 0.01～60%, be prepared into granularity and be not more than 10 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 0.01～30% is with the spherical mold moistening, then all the other medicated powder micronizing being become granularity is the superfine powder of 0.01～200 μ m, make the heavy pill of prescribed level, ball on the even ubiquitous spherical mold, dry or promptly with gained pill pack film-coat.
A kind of preparation method of medicine pill, be that the medical material of will filling a prescription earlier carries out micronizing to become granularity be the superfine powder of 0.01～200 μ m, get 10～99% ultramicro medicine powder, the binding agent that adds raw medicinal material total amount 0.01～60%, be prepared into granularity and be not more than 10 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material superfine powder, and is dry or with gained pill pack film-coat promptly.
A kind of preparation method of medicine pill is that the medical material of will filling a prescription earlier is ground into granularity and is not more than 10 purpose medicated powder, gets 10～99% medicated powder, adds the pharmaceutic adjuvant of medical material total amount 0～200%, adopts spherical module to be pressed into spherical mold; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medicated powder, and is dry or with gained pill pack film-coat promptly.
A kind of preparation method of medicine pill is that the medical material of will filling a prescription earlier is ground into granularity and is not more than 10 purpose medicated powder, gets 10～99% medicated powder, adds the pharmaceutic adjuvant of medical material total amount 0～200%, adopts spherical module to be pressed into spherical mold; The binding agent of reuse spherical mold total amount 0.01～30% is with the spherical mold moistening, then all the other medicated powder micronizing being become granularity is the superfine powder of 0.01～200 μ m, make the heavy pill of prescribed level, ball on the even ubiquitous spherical mold, dry or promptly with gained pill pack film-coat.
A kind of preparation method of medicine pill is that the medical material of will filling a prescription earlier carries out micronizing to become granularity be the superfine powder of 0.01～200 μ m, gets 10～99% medicated powder, adds the pharmaceutic adjuvant of medical material total amount 0～200%, adopts spherical module to be pressed into spherical mold; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material medicine superfine powder, and is dry or with gained pill pack film-coat promptly.
In the above-mentioned various preparation method, pharmaceutic adjuvant is at least a in lubricant, diluent, disintegrating agent, the binding agent.Wherein lubricant is a lubricant pharmaceutically commonly used, mainly contains magnesium stearate, Pulvis Talci, Macrogol 4000 and 6000, refining hydrogenated vegetable oil; Diluent is a diluent pharmaceutically commonly used, mainly contains starch, modified starch, dextrin, lactose, sucrose, microcrystalline cellulose, mannitol, sorbitol; Disintegrating agent is a disintegrating agent pharmaceutically commonly used, mainly contains starch, carboxylic first class Starch Sodium, starch hydroxy propionate, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, poly-rafter acid, malic acid, sodium alginate.
Binding agent in the above-mentioned various preparation method also is a binding agent pharmaceutically commonly used, and water, arabic gum, starch, ethanol, sodium carboxymethyl cellulose, 5-10% Mel, gelatin, syrup, tragcanth, crospolyvinylpyrrolidone, the low carboxy-propyl cellulose etc. that replaces are arranged.
When pill drying was carried out film coating, the film-coat material of employing had Opadry, acrylic resin, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, cellulose acetate-phthalate, ethyl cellulose, cellulose acetate etc.; The addition of film-coat is 1～5% of a raw medicinal material total amount.
The present invention compares with traditional pill making craft and has the following advantages:
1, the present invention adopts the method for granulation, compacting pill mould, general pharmacy ball, and it is irregular to have overcome traditional general pharmacy ball mould size, the shortcoming that process cycle is long.Process stabilizing.
2, the present invention adopts the method for granulation, compacting pill mould, general pharmacy ball, has overcome the unsettled shortcoming of pill dissolve scattered time limit that traditional general pharmacy ball mould different process personnel produce.
3, pill reference for modern pharmacy pressing process of the present invention, the pill mould adopts automated production, has reduced the pollution section of technical process.
4, pill mould of the present invention size evenly, particle diameter can be set by compacting tool set, and the shape of finished product pill, ball weight average meet the pharmacopeia requirement easily, and the ball method of double differences is different in ± 3%.
5, the present invention is with short production cycle, and batch production cycle is within 5 days; The production efficiency height, ten thousand/hour of 10-30.
Last general system when 6, the present invention is ground into impalpable powder or micronizing with raw medicinal material, the pill molding is easy, any surface finish.
7, pill of the present invention adopts superfine powder, makes the dissolution of crude drug effective ingredient improve 10%, and bioavailability is obviously improved, good absorbing, and curative effect is fast;
The specific embodiment
Embodiment 1, the medical material of will filling a prescription is ground into granularity 10 purpose medicated powder earlier, get 99% medicated powder, (binding agent is 10% Mel: gelatin: water=10: 1: 10) to add the binding agent of raw medicinal material total amount 60%, be prepared into granularity 10 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; 10% Mel of reuse spherical mold total amount 30% with making prescribed level, ball pill heavily on the even ubiquitous spherical mold of all the other medicated powder, is drying to obtain the spherical mold moistening then.
Embodiment 2, the medical material of will filling a prescription is ground into granularity 40 purpose medicated powder earlier, get 50% medicated powder, (binding agent is a syrup: tragcanth: the low carboxy-propyl cellulose=10: 1: 0.3 of replacing) to add the binding agent of raw medicinal material total amount 10%, be prepared into granularity 14 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; (the ethanol:, with making prescribed level, ball pill heavily on the even ubiquitous spherical mold of all the other medicated powder, be drying to obtain then of reuse spherical mold total amount 10% water=1: 10) with the spherical mold moistening.
Embodiment 3, the medical material of will filling a prescription is ground into granularity 80 purpose medicated powder earlier, gets 10% medicated powder, adds the water of raw medicinal material total amount 0.01%, is prepared into granularity 14 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The water of reuse spherical mold total amount 0.01%, with the spherical mold moistening, then will make on the even ubiquitous spherical mold of all the other medicated powder prescribed level, pill that ball is heavy, dry, with 3% Opadry bag film-coat, promptly.
Embodiment 4, the medical material of will filling a prescription is ground into granularity 60 purpose medicated powder earlier, get 80% medicated powder, (binding agent is a water: crospolyvinylpyrrolidone: the low carboxy-propyl cellulose=10: 0.01: 0.2 of replacing) to add the binding agent of raw medicinal material total amount 50%, be prepared into granularity 20 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The water of reuse spherical mold total amount 20% is with the spherical mold moistening, and then all the other medicated powder micronizing being become granularity is the superfine powder of 0.01～200 μ m, makes prescribed level, ball pill heavily on the even ubiquitous spherical mold, is drying to obtain.
Embodiment 5, the medical material of will filling a prescription is ground into granularity 80 purpose medicated powder earlier, get 60% medicated powder, (binding agent is a water: arabic gum: starch=10: 1: 1) to add the binding agent of raw medicinal material total amount 40%, be prepared into granularity 20 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; (binding agent is a water to the binding agent of reuse spherical mold total amount 10%: starch=10: 1) with the spherical mold moistening, then all the other medicated powder micronizing being become granularity is the superfine powder of 0.01～200 μ m, make prescribed level, ball pill heavily on the even ubiquitous spherical mold, dry, with 4% Opadry bag film-coat, promptly.
Embodiment 6, the medical material of will filling a prescription is ground into granularity and is not more than 10 purpose medicated powder earlier, get 49% medicated powder, (binding agent is a water: arabic gum: sodium carboxymethyl cellulose=10: 1: 0.01) to add the binding agent of raw medicinal material total amount 20%, be prepared into granularity 20 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 5% (water: arabic gum=10: 0.1) with the spherical mold moistening, then all the other medicated powder micronizing being become granularity is the micropowder of 150～180 μ m, make prescribed level, ball pill heavily on the even ubiquitous spherical mold, be drying to obtain.
Embodiment 7, be that the medical material of will filling a prescription earlier carries out micronizing to become granularity be the superfine powder of 0.01～0.1 μ m, get 10% ultramicro medicine powder, add the water of raw medicinal material total amount 0.1%, be prepared into granularity 10 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The water of reuse spherical mold total amount 10% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material superfine powder, and is dry or with the gained pill, with 5% Opadry bag film-coat, promptly.
Embodiment 8, be that the medical material of will filling a prescription earlier carries out micronizing to become granularity be the superfine powder of 10～20 μ m, get 20% ultramicro medicine powder, add 5% Mel of raw medicinal material total amount 0.5%, be prepared into granularity 14 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; 5% Mel of reuse spherical mold total amount 0.5% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material superfine powder, and is dry, wrap film-coat promptly according to a conventional method.
Embodiment 9 is that the medical material of will filling a prescription earlier carries out micronizing to become granularity be the superfine powder of 40～70 μ m, get 15% ultramicro medicine powder, add the water of raw medicinal material total amount 1%, be prepared into granularity 10 purpose granules, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The water of reuse spherical mold total amount 1% with making prescribed level, ball pill heavily on the even ubiquitous spherical mold of all the other medical material superfine powder, is drying to obtain the spherical mold moistening then.
Embodiment 10, will fill a prescription that to be ground into granularity be 10 purpose medicated powder to medical material earlier, get 10% medicated powder, and adopt spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 0.01% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medicated powder, and is dry or with gained pill pack film-coat promptly.
The preparation method of embodiment 11, a kind of medicine pill is that the medical material of will filling a prescription earlier is ground into granularity 20 purpose medicated powder, gets 30% medicated powder, adds Pulvis Talci, 10% sucrose, 10% microcrystalline cellulose of medical material total amount 10%, adopts spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 10% with making prescribed level, ball pill heavily on the even ubiquitous spherical mold of all the other medicated powder, is drying to obtain the spherical mold moistening then.
The preparation method of 12 1 kinds of medicine pills of embodiment, be that the medical material of will filling a prescription earlier is ground into granularity 10 purpose medicated powder, get 40% medicated powder, add the magnesium stearate, 10% starch of medical material total amount 20%, 10% lactose, 5% microcrystalline cellulose, 5% modified starch, adopt spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 30% with making prescribed level, ball pill heavily on the even ubiquitous spherical mold of all the other medicated powder, is drying to obtain the spherical mold moistening then.
Embodiment 13, be that the medical material of will filling a prescription earlier is ground into granularity 20 purpose medicated powder, get 50% medicated powder, add the magnesium stearate, 40% starch of medical material total amount 40%, 10% lactose, 5% microcrystalline cellulose, 5% modified starch, adopt spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 30% is with the spherical mold moistening, and then all the other medicated powder micronizing being become granularity is the superfine powder of 1～10 μ m, makes prescribed level, ball pill heavily on the even ubiquitous spherical mold, is drying to obtain.
Embodiment 14, be that the medical material of will filling a prescription earlier is ground into granularity and is not more than 10 purpose medicated powder, get 60% medicated powder, add medical material total amount 150% magnesium stearate, 20% starch, adopt spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 10%: arabic gum=10: 0.1, with the spherical mold moistening, then all the other medicated powder micronizing being become granularity is the superfine powder of 0.01～200 μ m, makes the heavy pill of prescribed level, ball on the even ubiquitous spherical mold, dry or with gained pill pack film-coat promptly.
Embodiment 15, be that the medical material of will filling a prescription earlier is ground into granularity 40 purpose medicated powder, get 99% medicated powder, add medical material total amount 100% magnesium stearate, 10% low-substituted hydroxypropyl cellulose, 60% starch,, adopt spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 30%: arabic gum=10: 0.1 is with the spherical mold moistening, then all the other medicated powder micronizing being become granularity is the superfine powder of 0.1～1 μ m, make the heavy pill of prescribed level, ball on the even ubiquitous spherical mold, dry or promptly with gained pill pack film-coat.
Embodiment 16, the medical material of will filling a prescription carries out micronizing to become granularity is the superfine powder of 0.01～0.1 μ m earlier, gets 80% medicated powder, adds medical material total amount 20% magnesium stearate, adopts spherical module to be pressed into spherical mold; 5% Mel of reuse spherical mold total amount 10% with 10% water-wet, will be made prescribed level, pill that ball is heavy with spherical mold then on the even ubiquitous spherical mold of all the other medical material medicine superfine powder, dry or with gained pill pack film-coat promptly.
Embodiment 17, the medical material of will filling a prescription carries out micronizing to become granularity is the superfine powder of 0.1～1 μ m earlier, gets 70% medicated powder, adds magnesium stearate, 10% dextrin of medical material total amount 60%, adopts spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 10% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material medicine superfine powder, and is dry or with gained pill pack film-coat promptly.
Embodiment 18, the medical material of will filling a prescription carries out micronizing to become granularity is the superfine powder of 0.1～0.5 μ m earlier, gets 80% medicated powder, adds magnesium stearate, 10% dextrin of medical material total amount 150%, adopts spherical module to be pressed into spherical mold; The water of reuse spherical mold total amount 15% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material medicine superfine powder, and is dry or with gained pill pack film-coat promptly.
Claims (15)
1, a kind of preparation method of medicine pill is that the medical material of will filling a prescription earlier is ground into medicated powder, gets 10～99% medicated powder, adds the binding agent of raw medicinal material total amount 0.01～60%, is prepared into granule, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medicated powder, and is dry or with gained pill pack film-coat promptly.
2, as the preparation method of medicine pill as described in claims 1, it is characterized in that: the granularity of described medicated powder is not more than 10 orders, and the grain graininess that is prepared into is not more than 10 orders.
3, a kind of preparation method of medicine pill is that the medical material of will filling a prescription earlier is ground into medicated powder, gets 10～99% medicated powder, adds the binding agent of raw medicinal material total amount 0.01～60%, is prepared into granule, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold after all the other medicated powder micronizing, and is dry or with gained pill pack film-coat promptly.
4, as the preparation method of medicine pill as described in the claim 3, it is characterized in that: the granularity of described medicated powder is not more than 10 orders, and the grain graininess that is prepared into is not more than 10 orders; The granularity of described superfine powder is 0.01-200 μ m.
5, a kind of preparation method of medicine pill is that the medical material of will filling a prescription earlier carries out micronizing, gets 10～99% ultramicro medicine powder, the binding agent that adds raw medicinal material total amount 0.01～60%, be prepared into granule, drying, and adopt spherical module to be pressed into spherical mold the dried particles; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material superfine powder, and is dry or with gained pill pack film-coat promptly.
6, as the preparation method of medicine pill as described in the claim 5, it is characterized in that: described particulate granularity is not more than 10 orders; The granularity of described superfine powder is 0.01-200 μ m.
7, the preparation method of medicine pill according to claim 1 is characterized in that: be that the medical material of will filling a prescription earlier is ground into medicated powder, get 10～99% medicated powder, add the pharmaceutic adjuvant of medical material total amount 0～200%, adopt spherical module to be pressed into spherical mold again; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medicated powder, and is dry or with gained pill pack film-coat promptly.
8, as the preparation method of medicine pill as described in claims 7, it is characterized in that: the granularity of described medicated powder is not more than 10 orders.
9, as the preparation method of medicine pill as described in the claim 7, it is characterized in that: described pharmaceutic adjuvant is at least a in lubricant, diluent, the disintegrating agent.
10, the preparation method of medicine pill according to claim 1 is characterized in that: be that the medical material of will filling a prescription earlier is ground into medicated powder, get 10～99% medicated powder, add the pharmaceutic adjuvant of medical material total amount 0～200%, adopt spherical module to be pressed into spherical mold; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold after all the other medicated powder micronizing, and is dry or with gained pill pack film-coat promptly.
11, as the preparation method of medicine pill as described in the claim 10, it is characterized in that: the grinding particle size of described medicated powder is not more than 10 orders; The granularity of described superfine powder is 0.01-200 μ m.
12, as the preparation method of medicine pill as described in the claim 10, it is characterized in that: described pharmaceutic adjuvant is at least a in lubricant, diluent, the disintegrating agent.
13, the preparation method of medicine pill according to claim 1 is characterized in that: be that the medical material of will filling a prescription earlier carries out micronizing, get 10～99% ultramicro medicine powder, add the pharmaceutic adjuvant of medical material total amount 0～200%, adopt spherical module to be pressed into spherical mold; The binding agent of reuse spherical mold total amount 0.01～30% is the spherical mold moistening, will make prescribed level, pill that ball is heavy then on the even ubiquitous spherical mold of all the other medical material medicine superfine powder, and is dry or with gained pill pack film-coat promptly.
14, as the preparation method of medicine pill as described in the claim 13, it is characterized in that: the granularity of described superfine powder is 0.01-200 μ m.
15, as the preparation method of medicine pill as described in the claim 11, it is characterized in that: described pharmaceutic adjuvant is at least a in lubricant, diluent, the disintegrating agent.
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| CNB2006100430448A CN100431527C (en) | 2006-06-24 | 2006-06-24 | Chinese medicine bolus preparing process |
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| CNB2006100430448A CN100431527C (en) | 2006-06-24 | 2006-06-24 | Chinese medicine bolus preparing process |
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| CN100431527C true CN100431527C (en) | 2008-11-12 |
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| CN108514551A (en) * | 2018-05-18 | 2018-09-11 | 北京同仁堂制药有限公司 | A kind of preparation method of medicine pill |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1428143A (en) * | 2002-12-28 | 2003-07-09 | 袁彦洁 | Method for preparing micropill by using Chinese patent medicine extract and its pill-making machine |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1428143A (en) * | 2002-12-28 | 2003-07-09 | 袁彦洁 | Method for preparing micropill by using Chinese patent medicine extract and its pill-making machine |
Non-Patent Citations (2)
| Title |
|---|
| 中药水丸剂制备中几个关键问题的研究. 王圣泉.现代中药研究与实践，第10卷第2期. 1996 |
| 中药水丸剂制备中几个关键问题的研究. 王圣泉.现代中药研究与实践，第10卷第2期. 1996 * |
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