CN102218092A - Dispersion tablets of traditional Chinese medicine composition - Google Patents
Dispersion tablets of traditional Chinese medicine composition Download PDFInfo
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- CN102218092A CN102218092A CN2010101484649A CN201010148464A CN102218092A CN 102218092 A CN102218092 A CN 102218092A CN 2010101484649 A CN2010101484649 A CN 2010101484649A CN 201010148464 A CN201010148464 A CN 201010148464A CN 102218092 A CN102218092 A CN 102218092A
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Abstract
The invention discloses dispersion tablets of a traditional Chinese medicine composition, Chinese thorowax root, virgate wormwood herb, indigowoad root and mung bean (pulverized) are decocted with water twice with 2 hours for every time, thereby obtaining clear paste A; and Chinese magnoliavine fruit is pulverized into coarse powder, and extraction with 90% ethanol is performed on the coarse powder and porcine gall powder to obtain extract B. The clear paste A and the extract B are uniformly mixed, dried at the temperature of 70 DEG C and pulverized into fine powder, thus obtaining the fine powder of the extract of the traditional Chinese medicine composition; the fine powder is further uniformly mixed with sodium carboxymethyl starch, crosslinked polyethylene pyrrolidone, crosslinked sodium carboxymethyl cellulose, microcrystalline cellulose, low substituted hydroxypropy cellulose, lactose and other auxiliary materials; and granulation is performed through the dry pressing process, 16-mesh size granulation is performed, magnesium stearate is added, and uniform mixing and tabletting are performed, thus obtaining the dispersion tablets.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition composition dispersible tablets, belong to formulation art.
Background technology
The M ﹠ M of viral hepatitis has accounted for the first place in the infectious disease of China's statutory report.Hepatitis virus comprises first, second, third, fourth, penta, hepatitis G virus, and virus is invaded liver, duplicates propagation in hepatocyte, and the reaction that causes inflammation takes place.Wherein hepatitis B virus (HBV) infect the most general in the crowd, hepatitis B popular because of the area different.The sickness rate height in China, Southeast Asia and Africa, the sickness rate in West Europe, North America and Australia is low.The whole world has 3.5 hundred million to be hepatitis B virus carriers approximately, and what attract people's attention is that wherein about 3/4 in the Asia.
China is the district occurred frequently that HBV infects, and according to 1992-1995 whole nation viral hepatitis seroepidemiological survey, crowd HBsAg carrying rate reaches 9.75%, about 1.2 hundred million people.About 3,000 ten thousand people of chronic hepatitis B patient wherein.At present, in China, the crowd that 50%-70% is arranged is once by hepatitis b virus infected mistake, and about 10% crowd is a hepatitis b virus carrier.About 15% hepatitis B patient can develop into liver cirrhosis and hepatocarcinoma, and the hepatocarcinoma 80%-90% of China has the background of hepatitis B virus infection.HBV infect be China's liver cirrhosis and hepatocarcinoma main diseases because of.
Also do not treat at present the specific drug of hepatitis B, the whole nation be used for the treatment of hepatitis in, western drug reach hundreds of, the liver-protecting tablet determined curative effect, steady quality, entered national essential drugs catalogue and social medical insurance medicine catalogue, but liver-protecting tablet is a coated tablet, not only disintegration time is long, absorb in the body slowly, and the sugar content height, dose is big, diabetes, hyperlipidemia can produce untoward reaction when sugar avoiding patients such as hypertension are taken.
Summary of the invention
The object of the present invention is to provide a kind of dispersible tablet of Chinese medicine composition; Another object of the present invention is to disclose a kind of preparation method of dispersible tablet of Chinese medicine composition.
The crude drug of Chinese medicine composition composition dispersible tablets of the present invention is formed and proportioning following (by weight):
Chinese medicine composition extract fine powder 30---100 weight portion
Carboxymethyl starch sodium 5---100 weight portion
Crospolyvinylpyrrolidone 5---150 weight portion
Magnesium stearate 0.3---10 weight portion
Lactose 90---200 weight portion;
Cross-linking sodium carboxymethyl cellulose 10---60 weight portion
Microcrystalline Cellulose 10---100 weight portion
Low-substituted hydroxypropyl cellulose 0---100 weight portion.
The crude drug of Chinese medicine composition composition dispersible tablets of the present invention is formed and proportion optimization following (by weight):
Chinese medicine composition extract fine powder 40---80 weight portion
Carboxymethyl starch sodium 20---50 weight portion
Crospolyvinylpyrrolidone 20---70 weight portion
Magnesium stearate 0.3---10 weight portion
Lactose 130---180 weight portion;
Cross-linking sodium carboxymethyl cellulose 10---50 weight portion
Microcrystalline Cellulose 10---70 weight portion
Low-substituted hydroxypropyl cellulose 0---50 weight portion.
Described Chinese medicine composition extract is that crude drug consists of: Radix Bupleuri 313g Herba Artemisiae Scopariae 313g Radix Isatidis 313g Fructus Schisandrae Chinensis 168g Pulvis Fellis Suis 20g Semen phaseoli radiati 128g;
The Chinese medicine composition preparation method of extract is that crude drug extracts through routine and makes dry fine powder.
The Chinese medicine composition preparation method of extract is preferably: Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, Semen phaseoli radiati (pulverizing) decoct with water secondary, and each 2 hours, filter, it is the clear paste A of 1.30 (80 ℃) that merging filtrate, concentrating under reduced pressure become relative density; Fructus Schisandrae Chinensis powder is broken into coarse powder and Pulvis Fellis Suis with 90% soak with ethanol 4 hours, reflux, extract, 1 hour, and dynamically hot reflux is 6 hours, reclaims ethanol, and being concentrated into relative density is 1.20 (80 ℃) extractum B.The mixing of clear paste A and extractum B, dry below 70 ℃, be ground into fine powder, get Chinese medicine composition extract fine powder.
The preparation method of dispersible tablet of the present invention comprises the steps:
1, with Chinese medicine composition extract fine powder and each adjuvant difference porphyrize, it is standby to cross the 80--100 mesh sieve;
2, press recipe quantity with adjuvant mix homogeneously such as Chinese medicine composition extract fine powder and carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, lactose;
3, with dry pressing granulation, 16 order granulate, add magnesium stearate, mix homogeneously, tabletting are promptly.
Liver-protecting tablet has definite curative effect in the treatment hepatopathy, but present dosage form only has tablet, does not also have dispersible tablet at present; Dispersible tablet is as a kind of new dosage form, it is with particular performances, extremely people pay close attention in recent years, and it has easy to use, absorb fast, the bioavailability advantages of higher, overcome and swallowed the trouble that the inconvenient patient of solid drugs brings,, existed in the water unstable though can avoid the liquid preparation taking convenience again, packaging volume is excessive, and patient carries and transport, stores problems such as inconvenience.Described liver-protecting tablet dispersible tablet formulation is taken after can disperseing in water, carries, taking convenience the bioavailability height.
Following experimental example further specifies the present invention.
Experimental example 1The prescription screening experiment
1, instrument and supplementary material
Tablet machine: (model: DP30);
Disintegration tester: (model: ZB6);
Balance: (model: FA1004, manufacturer: Shanghai balance equipment factory).
Table 1 supplementary material source
2 methods:
(1), disintegrating agent is selected:
Under this prescription medicated powder and the constant situation of filler, with medicated powder and the disintegrating agent mixed according to 1: 1, tabletting is to investigate index with the disintegration time, the results are shown in Table 2:
The screening of table 2 disintegrating agent kind
The result shows that crospolyvinylpyrrolidone in six kinds of disintegrating agents, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose disintegrate effect difference are little, but independent use can not meet the demands as the disintegrate adjuvant.
Employing is used in combination the method for disintegrating agent, test disintegrate effect: select crospolyvinylpyrrolidone (1), cross-linking sodium carboxymethyl cellulose (2), carboxymethyl starch sodium (3), low-substituted hydroxypropyl cellulose (4), microcrystalline Cellulose (5) screen once more.
Disintegrating agent use in conjunction screening experiment:
Under medicated powder and the constant situation of lactose, with medicated powder and the mixed of total disintegrating agent according to 1: 1, tabletting is to investigate index with the disintegration time, and the result is as follows:
The screening of table 3 disintegrating agent use in conjunction
The result of the test that does not add crospolyvinylpyrrolidone according to identical experimental technique is as follows:
The screening of table 4 disintegrating agent use in conjunction
According to above result as can be seen, after two kinds of disintegrating agent use in conjunction,, but still can not satisfy requirement as this dispersible tablet disintegrate adjuvant though disintegration time slightly reduces.
(2) part test of adjuvant such as disintegrating agent and filler combination
The experiment of table 5 combined sorting
Experimental technique:
1, slaking test: press official method under 20 ± 1 ℃ of water temperatures and measure disintegration time;
2, each 2 in different tablets of writing out a prescription are got in the dispersing uniformity test, add 20 ± 1 ℃ of water 100ml jolting respectively, whether all sieve (850 μ m) by No. 2 in 3 minutes;
3, each 1 in the tablets of different prescriptions are got in suspension ability test, add respectively in the 50ml water (20 ± 1 ℃), fully stir, and pour into immediately in the 50ml graduated cylinder, observe the height of sedimentation face and the outward appearance of suspension after leaving standstill certain hour.
Result of the test:
Have beyond thought effect by above test recipe 3, its 1 ' 34 ' is by screen cloth time spent, and be uniformly dispersed, outward appearance is good, sedimentation velocity is slow.Manufactured experimently 5 batch samples according to prescription 3, all met the requirements.Write out a prescription 3 successes solution liver-protecting tablet prepare the technical problem of dispersible tablet novel form.Through pilot plant test, verified that the prescription of determining has reached prescription fully.
The experiment of experimental example 2 bioequivalences
Dispersible tablet of the present invention and certain listing ordinary tablet have carried out human-body biological equivalence result of the test and have shown: the InC of two kinds of preparations
Max, InAUC
0 → 24Through three-factor analysis of variance, show the InC of two preparations
Max, InAUC
0 → 24Significant difference is all arranged.The on average the highest blood drug level that is subjected to test preparation is than the conventional tablet height.The T of two kinds of preparations
MaxAdopt non parametric tests, assay has significant difference, is subjected to the peak time T of test preparation
MaxSignificantly faster than conventional tablet; InC
Max, InAUC
0 → 24Show that through two one-side t checks dispersible tablet is better than conventional tablet.
Following examples can reach the effect of above-mentioned experimental example.
Embodiment 1
Liver-protecting tablet extract fine powder 60g
Carboxymethyl starch sodium 30g
Crospolyvinylpyrrolidone 45g
Cross-linking sodium carboxymethyl cellulose 20g
Microcrystalline Cellulose 40g
Low-substituted hydroxypropyl cellulose 20g
Magnesium stearate 4g
Lactose 160g
Make 1000
Preparation method:
The preparation of liver-protecting tablet extract fine powder: Radix Bupleuri 313g Herba Artemisiae Scopariae 313g Radix Isatidis 313g Fructus Schisandrae Chinensis 168g Pulvis Fellis Suis 20g Semen phaseoli radiati 128g; Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, Semen phaseoli radiati (pulverizing) decoct with water secondary, and each 2 hours, filter, it is the clear paste A of 1.30 (80 ℃) that merging filtrate, concentrating under reduced pressure become relative density; Fructus Schisandrae Chinensis powder is broken into coarse powder and Pulvis Fellis Suis with 90% soak with ethanol 4 hours, reflux, extract, 1 hour, and dynamically hot reflux is 6 hours, reclaims ethanol, and being concentrated into relative density is 1.20 (80 ℃) extractum B.The mixing of clear paste A and extractum B, dry below 70 ℃, be ground into fine powder, get Chinese medicine composition extract fine powder;
With liver-protecting tablet extract fine powder and each adjuvant difference porphyrize, it is standby to cross 80 mesh sieves; Press recipe quantity with adjuvant mix homogeneously such as principal agent and carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, lactose; Granulate with dry pressing, 16 order granulate add magnesium stearate, and mix homogeneously, tabletting are promptly.
Embodiment 2
Liver-protecting tablet extract fine powder 60g
Carboxymethyl starch sodium 15g
Crospolyvinylpyrrolidone 30g
Cross-linking sodium carboxymethyl cellulose 15g
Microcrystalline Cellulose 30g
Low-substituted hydroxypropyl cellulose 0g
Magnesium stearate 4g
Lactose 160g
Make 1000
Preparation method:
The preparation of liver-protecting tablet extract fine powder: Radix Bupleuri 313g Herba Artemisiae Scopariae 313g Radix Isatidis 313g Fructus Schisandrae Chinensis 168g Pulvis Fellis Suis 20g Semen phaseoli radiati 128g; Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, Semen phaseoli radiati (pulverizing) decoct with water secondary, and each 2 hours, filter, it is the clear paste A of 1.30 (80 ℃) that merging filtrate, concentrating under reduced pressure become relative density; Fructus Schisandrae Chinensis powder is broken into coarse powder and Pulvis Fellis Suis with 90% soak with ethanol 4 hours, reflux, extract, 1 hour, and dynamically hot reflux is 6 hours, reclaims ethanol, and being concentrated into relative density is 1.20 (80 ℃) extractum B.The mixing of clear paste A and extractum B, dry below 70 ℃, be ground into fine powder, get Chinese medicine composition extract fine powder;
With liver-protecting tablet extract fine powder and each adjuvant difference porphyrize, it is standby to cross 80 mesh sieves; Press recipe quantity with adjuvant mix homogeneously such as principal agent and carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, lactose; Granulate with dry pressing, 16 order granulate add magnesium stearate, and mix homogeneously, tabletting are promptly.
Claims (6)
1. Chinese medicine composition composition dispersible tablets is characterized in that this dispersible tablet mainly made by following raw material:
Chinese medicine composition extract fine powder 30---100 weight portion
Carboxymethyl starch sodium 5---100 weight portion
Crospolyvinylpyrrolidone 5---150 weight portion
Magnesium stearate 0.3---10 weight portion
Lactose 90---200 weight portion;
Cross-linking sodium carboxymethyl cellulose 10---60 weight portion
Microcrystalline Cellulose 10---100 weight portion
Low-substituted hydroxypropyl cellulose 0---100 weight portion;
The crude drug of described Chinese medicine composition extract fine powder consists of: Radix Bupleuri 313 weight portion Herba Artemisiae Scopariaes 313 weight portion Radix Isatidis 313 weight portion Fructus Schisandrae Chinensis 168 weight portion Pulvis Fellis Suiss 20 weight portion Semen phaseoli radiatis 128 weight portions; Crude drug extracts through routine and makes dry fine powder.
2. dispersible tablet as claimed in claim 1 is characterized in that this dispersible tablet mainly made by following raw material:
Chinese medicine composition extract fine powder 40---80 weight portion
Carboxymethyl starch sodium 20---50 weight portion
Crospolyvinylpyrrolidone 20---70 weight portion
Magnesium stearate 0.3---10 weight portion
Lactose 130---180 weight portion;
Cross-linking sodium carboxymethyl cellulose 10---50 weight portion
Microcrystalline Cellulose 10---70 weight portion
Low-substituted hydroxypropyl cellulose 0---50 weight portion.
3. dispersible tablet as claimed in claim 2 is characterized in that this dispersible tablet mainly made by following raw material:
Chinese medicine composition extract fine powder 60 weight portions
Carboxymethyl starch sodium 30 weight portions
Crospolyvinylpyrrolidone 45 weight portions
Cross-linking sodium carboxymethyl cellulose 20 weight portions
Microcrystalline Cellulose 40 weight portions
Low-substituted hydroxypropyl cellulose 20 weight portions
Magnesium stearate 4 weight portions
Lactose 160 weight portions.
4. dispersible tablet as claimed in claim 2 is characterized in that this dispersible tablet mainly made by following raw material:
Chinese medicine composition extract fine powder 60 weight portions
Carboxymethyl starch sodium 15 weight portions
Crospolyvinylpyrrolidone 30 weight portions
Cross-linking sodium carboxymethyl cellulose 15 weight portions
Microcrystalline Cellulose 30 weight portions
Low-substituted hydroxypropyl cellulose 0 weight portion
Magnesium stearate 4 weight portions
Lactose 160 weight portions.
5. dispersible tablet as claimed in claim 1 is characterized in that the preparation method of Chinese medicine composition extract fine powder comprises the steps:
Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, Semen phaseoli radiati (pulverizing) decoct with water secondary, and each 2 hours, filter, it is the clear paste A of 1.30 (80 ℃) that merging filtrate, concentrating under reduced pressure become relative density; Fructus Schisandrae Chinensis powder is broken into coarse powder and Pulvis Fellis Suis with 90% soak with ethanol 4 hours, reflux, extract, 1 hour, and dynamically hot reflux is 6 hours, reclaims ethanol, and being concentrated into relative density is 1.20 (80 ℃) extractum B.The mixing of clear paste A and extractum B, dry below 70 ℃, be ground into fine powder, get Chinese medicine composition extract fine powder.
6. dispersible tablet as claimed in claim 1 is characterized in that the preparation method of dispersible tablet comprises the steps:
With Chinese medicine composition extract fine powder and each adjuvant difference porphyrize, it is standby to cross the 80--100 mesh sieve;
Press recipe quantity with adjuvant mix homogeneously such as Chinese medicine composition extract fine powder and carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, lactose;
With dry pressing granulation, 16 order granulate, add magnesium stearate, mix homogeneously, tabletting are promptly.
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| CN2010101484649A CN102218092B (en) | 2010-04-14 | 2010-04-14 | Dispersion tablets of traditional Chinese medicine composition |
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| CN2010101484649A CN102218092B (en) | 2010-04-14 | 2010-04-14 | Dispersion tablets of traditional Chinese medicine composition |
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| CN102218092B CN102218092B (en) | 2012-12-05 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102397335A (en) * | 2011-11-18 | 2012-04-04 | 青岛绿曼生物工程有限公司 | Pure Chinese medicinal composition for treating poultry fatty liver haemorrhage syndrome and preparation method thereof |
| CN102512500A (en) * | 2012-01-10 | 2012-06-27 | 天圣制药集团股份有限公司 | Preparation for treating chronic hepatitis and cirrhosis and preparation method of preparation |
| CN103316056A (en) * | 2013-06-24 | 2013-09-25 | 江苏鹏鹞药业有限公司 | Radix isatidis coating dispersible tablet and preparation method thereof |
| CN107519292A (en) * | 2017-08-24 | 2017-12-29 | 黑龙江葵花药业股份有限公司 | A kind of preparation method of liver-protecting tablet with high-dissolution and products thereof and application |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1843431A (en) * | 2006-02-22 | 2006-10-11 | 山东润华药业有限公司 | Medicine for treating hepatitis and its preparing process |
-
2010
- 2010-04-14 CN CN2010101484649A patent/CN102218092B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1843431A (en) * | 2006-02-22 | 2006-10-11 | 山东润华药业有限公司 | Medicine for treating hepatitis and its preparing process |
Non-Patent Citations (1)
| Title |
|---|
| 《人参研究》 20000331 安玉明 护肝片醇提部分提取工艺的考察和优选 39－44 1－6 , 第3期 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102397335A (en) * | 2011-11-18 | 2012-04-04 | 青岛绿曼生物工程有限公司 | Pure Chinese medicinal composition for treating poultry fatty liver haemorrhage syndrome and preparation method thereof |
| CN102512500A (en) * | 2012-01-10 | 2012-06-27 | 天圣制药集团股份有限公司 | Preparation for treating chronic hepatitis and cirrhosis and preparation method of preparation |
| CN103316056A (en) * | 2013-06-24 | 2013-09-25 | 江苏鹏鹞药业有限公司 | Radix isatidis coating dispersible tablet and preparation method thereof |
| CN103316056B (en) * | 2013-06-24 | 2015-07-08 | 江苏鹏鹞药业有限公司 | Radix isatidis coating dispersible tablet and preparation method thereof |
| CN107519292A (en) * | 2017-08-24 | 2017-12-29 | 黑龙江葵花药业股份有限公司 | A kind of preparation method of liver-protecting tablet with high-dissolution and products thereof and application |
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| Publication number | Publication date |
|---|---|
| CN102218092B (en) | 2012-12-05 |
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