CN101590026A - A kind of preparation method of Tiopronin enteric-coated tablet - Google Patents
A kind of preparation method of Tiopronin enteric-coated tablet Download PDFInfo
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- CN101590026A CN101590026A CNA2008101137078A CN200810113707A CN101590026A CN 101590026 A CN101590026 A CN 101590026A CN A2008101137078 A CNA2008101137078 A CN A2008101137078A CN 200810113707 A CN200810113707 A CN 200810113707A CN 101590026 A CN101590026 A CN 101590026A
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- tiopronin
- enteric
- preparation
- coating
- plain sheet
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Abstract
The invention provides a kind of preparation method of Tiopronin enteric-coated tablet.This method comprises the plain sheet of preparation tiopronin, plain sheet bag contagion gown and step such as enteric coated.The Tiopronin enteric-coated tablet technology of producing according to the method for the invention is simple, cost is low, can effectively cover tiopronin specificity stink.
Description
Technical field
The present invention relates to the crude drug field, be specifically related to a kind of preparation method of Tiopronin enteric-coated tablet.
Background technology
Tiopronin is the glycine derivative of Japan initiative in 1963, and toxic and side effects is little, can be used for treatments such as chronic hepatitis and liver cirrhosis, uses at state approvals such as Japan, Italy in succession.
Tiopronin generates glycine in vivo by the amidase hydrolysis, and it is synthetic mainly to participate in purine class nucleic acid, so have the effect that promotes liver cell regeneration.And can activate superoxide dismutase, increase the function of detoxification of liver.Tiopronin also can promote the drainage of heavy metal and poisonous substance thereof, has important detoxifcation and hepatoprotective effect.The present clinical viral hepatitis that has been widely used in, alcoholic hepatitis, drug induced hepatitis, heavy metal poisoning hepatitis, fatty liver and liver cirrhosis early treatment; Be used to reduce the toxic and side effects of radiotherapy, chemotherapy, leukocyte increasing also quickens hepatocellular recovery, reduces the generation of bone marrow stain body aberration rate and skin ulcer, and can prevent the generation of caused by radiation secondary tumor; Early senile cataract and vitreous opacity there is remarkable therapeutical effect; Prevention and treatment urinary system cystine stone; The antiinflammatory anti-allergic effects is arranged, dermatitis, eczema, acne and urticaria are had better curative effect.
Because the tiopronin raw material has the specificity stink, and acidity is stronger, the oral drug that goes on the market at present mostly is enteric coatel tablets, stimulates with the acidity that alleviates stomach.Because its specificity stink is stronger, the commercially available prod is many at present can not effectively cover its abnormal smells from the patient, causes the patient to produce the psychology of conflicting to taking this medicine, is unfavorable for patient's medication.Adopt the mode that increases enteric coating thickness, special stink has been covered certain effect, but not obvious, cause the enteric coatel tablets stripping slow simultaneously, drug quality can't guarantee.
Address the above problem, can improve on preparation prescription and technology, the adjuvant of raw material abnormal smells from the patient can be covered and adsorb to employing, and by optimizing on the technology, make and distribute abnormal smells from the patient minimizing as far as possible.And on coating material uses, adopt compact structure, the coating material that solubility property is good is guaranteeing effectively taste masking on the dissolving out capability basis.
Summary of the invention
(1) technical problem that will solve
The preparation method that the purpose of this invention is to provide a kind of Tiopronin enteric-coated tablet.
(2) technical scheme
The invention provides a kind of preparation method of Tiopronin enteric-coated tablet, it comprises the steps:
(1) the plain sheet of preparation tiopronin: the tiopronin raw material is mixed pulverizing with adjuvants such as starch, microcrystalline Cellulose, and with the bonding granulation of starch slurry, magnesium stearate is added in the oven dry back, and tabletting is made the plain sheet of tiopronin;
(2) plain sheet bag contagion gown: with the plain sheet of tiopronin film-coat powder solution coating;
(3) enteric coated: as will to wrap contagion gown tiopronin sheet afterwards with enteric coating powder solution coating, and make Tiopronin enteric-coated tablet.
Wherein, the used material ratio of step (1) is by weight: tiopronin 10-50 part, starch 10-50 part, microcrystalline Cellulose 10-50 part, magnesium stearate 0.2-2 part, used starch slurry concentration is 5-15%.
The used film-coat powder of step (2) is a water-soluble material, and the coating weightening finish is 1-3%.
The used enteric coating powder coating weightening finish of step (3) is 6-18%.
(3) beneficial effect
Adopt method of the present invention can effectively reduce the specificity stink of tiopronin, because of the granule taste that the bonding granulation of starch slurry uses granulating process such as other binding agents and ethanol to make slighter; Simultaneously, by adopting the film-coat material, can effectively hide the raw material abnormal smells from the patient, and not influence the preparation stripping as sealing coat.This method technology is simple, cost is low.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
The preparation of embodiment 1 Tiopronin enteric-coated tablet
1, take by weighing tiopronin 100 grams, starch 100 grams, microcrystalline Cellulose 40 grams, mix and pulverize, 10% starch slurry is bonding, and 20 mesh sieves are granulated, 50 ℃ of forced air dryings 4 hours, 18 mesh sieve granulate add 2 gram magnesium stearate, mix homogeneously, tabletting, the plain sheet of preparation tiopronin;
2, water-soluble film-coat coating powder is mixed with coating powder solution, to plain sheet bag film-coat, as sealing coat, coating weightening finish 2.1%;
3, the enteric coating coating powder is mixed with enteric coating powder solution, and is enteric coated to the previous step goods, coating weightening finish 10.3%.Make Tiopronin enteric-coated tablet.Aluminium-plastic bubble plate packing gets product.
The preparation of embodiment 2 Tiopronin enteric-coated tablets
1, take by weighing tiopronin 100 gram, starch 80 grams, microcrystalline Cellulose 60 grams, mix and pulverize, 10% starch slurry is bonding, and 20 mesh sieves are granulated, 50 ℃ of forced air dryings 4 hours, and 18 mesh sieve granulate add 1 gram magnesium stearate, mix homogeneously, tabletting, the plain sheet of preparation tiopronin;
2, water-soluble film-coat coating powder is mixed with coating powder solution, to plain sheet bag film-coat, as sealing coat.Coating weightening finish 1.8%;
3, the enteric coating coating powder is mixed with enteric coating powder solution, and is enteric coated to the previous step goods, coating weightening finish 12.1%.Make Tiopronin enteric-coated tablet.Aluminium-plastic bubble plate packing gets product.
Embodiment 3 detects
Get the sample that embodiment 1 and embodiment 2 make and detect, all no longer have the specificity stink of raw material.Detect through stripping, above-mentioned sample is 2 hours equal no changes of tablet appearance in the 0.1M hydrochloric acid solution, are respectively 98.3%, 99.2% through 45 minutes dissolutions in pH 6.8 phosphate solutions.Therefore, adopt the Tiopronin enteric-coated tablet of the method for the invention preparation, can effectively cover the specificity stink of raw material, and stripping meets national related request.
Claims (4)
1, a kind of preparation method of Tiopronin enteric-coated tablet, it comprises the steps:
(1) the plain sheet of preparation tiopronin: the tiopronin raw material is mixed pulverizing with adjuvants such as starch, microcrystalline Cellulose, and with the bonding granulation of starch slurry, magnesium stearate is added in the oven dry back, and tabletting is made the plain sheet of tiopronin;
(2) plain sheet bag contagion gown: with the plain sheet of tiopronin film-coat powder solution coating;
(3) enteric coated: as will to wrap contagion gown tiopronin sheet afterwards with enteric coating powder solution coating, and make Tiopronin enteric-coated tablet.
2, method according to claim 1, it is characterized in that the used material ratio of step (1) is by weight: tiopronin 10-50 part, starch 10-50 part, microcrystalline Cellulose 10-50 part, magnesium stearate 0.2-2 part, used starch slurry concentration is 5-15%.
3, method according to claim 1 is characterized in that the used film-coat powder of step (2) is a water-soluble material, and the coating weightening finish is 1-3%.
4, method according to claim 1 is characterized in that the used enteric coating powder coating weightening finish of step (3) is 6-18%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101137078A CN101590026B (en) | 2008-05-29 | 2008-05-29 | Method for preparing Tiopronin enteric-coated tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101137078A CN101590026B (en) | 2008-05-29 | 2008-05-29 | Method for preparing Tiopronin enteric-coated tablet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101590026A true CN101590026A (en) | 2009-12-02 |
| CN101590026B CN101590026B (en) | 2011-04-13 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2008101137078A Active CN101590026B (en) | 2008-05-29 | 2008-05-29 | Method for preparing Tiopronin enteric-coated tablet |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552207A (en) * | 2011-12-15 | 2012-07-11 | 苏州二叶制药有限公司 | Tiopronin enteric capsule prescription and preparation process thereof |
| CN103705482A (en) * | 2014-01-15 | 2014-04-09 | 宜昌长江药业有限公司 | Preparation method of tiopronin tablets |
| US11458104B1 (en) | 2018-06-21 | 2022-10-04 | Mission Pharmacal Company | Enteric coated tiopronin tablet |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686100A (en) * | 2005-05-16 | 2005-10-26 | 河南省新谊药业股份有限公司 | Sodium thio pronine medicinal composition used for treating acute and chronic hepatitis |
| CN101045044A (en) * | 2006-03-27 | 2007-10-03 | 魏秀华 | Thipronin enteric-coated delayed-release agent |
-
2008
- 2008-05-29 CN CN2008101137078A patent/CN101590026B/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552207A (en) * | 2011-12-15 | 2012-07-11 | 苏州二叶制药有限公司 | Tiopronin enteric capsule prescription and preparation process thereof |
| CN103705482A (en) * | 2014-01-15 | 2014-04-09 | 宜昌长江药业有限公司 | Preparation method of tiopronin tablets |
| US11458104B1 (en) | 2018-06-21 | 2022-10-04 | Mission Pharmacal Company | Enteric coated tiopronin tablet |
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| Publication number | Publication date |
|---|---|
| CN101590026B (en) | 2011-04-13 |
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Address after: 100176, 6 Jingdong street, Beijing economic and Technological Development Zone Co-patentee after: Chengdu Beite Pharmaceutical Co., Ltd Patentee after: Beijing Kawin Biotechnology Co., Ltd. Address before: 100176, 6 Jingdong street, Beijing economic and Technological Development Zone Co-patentee before: CHENGDU BRILLIANT PHARMACEUTICAL Co.,Ltd. Patentee before: Beijing Kawin Biotechnology Co., Ltd. |
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