CN1618426A - Medicinal composition contg. katopril, and its prepn. method - Google Patents
Medicinal composition contg. katopril, and its prepn. method Download PDFInfo
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- CN1618426A CN1618426A CN 200310108775 CN200310108775A CN1618426A CN 1618426 A CN1618426 A CN 1618426A CN 200310108775 CN200310108775 CN 200310108775 CN 200310108775 A CN200310108775 A CN 200310108775A CN 1618426 A CN1618426 A CN 1618426A
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- China
- Prior art keywords
- captopril
- starch
- weight percent
- lactose
- pvp
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
A composite medicine containing captopril is prepared from captopril, microcrystalline cellulose, lactose, starch, hydroxypropyl cellulose, pregelatinized starch, magnesium stearate and polyvidone K30 through respectively granulating and mixing.
Description
Technical field
The present invention relates to the hypertensive medicine of a kind of treatment, relate to pharmaceutical composition that contains captopril and preparation method thereof specifically.
Background technology
Captopril is a kind of vasodilator, has good antihypertensive function, and its general structure is as follows:
At present, existing numerous bibliographical information contain pharmaceutical composition of active component captopril and preparation method thereof, but be wet granulation, owing to contain sulfydryl in the structure of captopril, in wet granulation technology, contain water, make the sulfydryl hydrolysis, harmful components increase, and influence the quality of product, complex technical process, the production cost height, product content instability, disulphide content height, can not satisfy the needs of the parties concerned, therefore must make improvements, developmental research is new contains pharmaceutical composition of captopril and preparation method thereof, satisfies the needs of the parties concerned.
Summary of the invention
One of technical issues that need to address of the present invention are to disclose a kind of pharmaceutical composition that contains captopril, to overcome the complex technical process that prior art exists, production cost height, the high defective of the unstable disulphide content of product content;
Two of the technical issues that need to address of the present invention provide the preparation of drug combination method of described captopril.
Technical scheme of the present invention:
A kind of pharmaceutical composition that contains captopril, its component and weight percent content comprise:
Captopril 0.5~1.5%
Microcrystalline Cellulose 0.5~1.5%
Lactose 2~3.5%
Starch 0.1~1%
Hyprolose 0.1~1%
Pregelatinized Starch 0.1~1%
Magnesium stearate 0.01~0.1%
30 POVIDONE K 30 BP/USP 30 (PVP.k30) 91~96.69%
Preferably:
Captopril 1.0%
Microcrystalline Cellulose 1.0%
Lactose 2.7%
Starch 0.50
Hyprolose 0.40
Pregelatinized Starch 0.55%
Magnesium stearate 0.05%
30 POVIDONE K 30 BP/USP 30 (PVP.k30) 93.8%.
Preparation method of the present invention comprises the steps:
(1) with lactose, starch, pregelatinized Starch, hyprolose, stir, cross 16 mesh sieves, adopting method well known in the art to add weight percent concentration is 3~10% PVP, weight percent concentration is 45~55% alcoholic solution, wet granulation, 75~85 ℃ of dryings 2~6 hours, turned over baking in dry 1~2 hour, granule is through 16 eye mesh screen granulate;
(2) captopril, microcrystalline Cellulose stir, and cross 16 mesh sieves, and dry-pressing granulate, dry press are set roller pressure 5-5.5Mpa;
(3), add magnesium stearate, the mix homogeneously of recipe quantity with above-mentioned two kinds of granules.
The present invention changes granulating process into the part dry-pressing by whole wet granulations and granulates, the part wet granulation, and remix is even.Product content is stable, and disulphide content is lower, meets " the prescription of Chinese pharmacopoeia P131~2 regulations.
The specific embodiment
Embodiment 1
(1) with lactose 6kg, starch 1kg, pregelatinized Starch 1.5kg, hyprolose 1kg, stir, cross 16 mesh sieves, adopting method well known in the art to add weight percent concentration is 5% PVP, and weight percent concentration is 50% alcoholic solution, wherein, 30 POVIDONE K 30 BP/USP 30 (PVP.k30) 210g, wet granulation, 80 ℃ of dryings 4 hours, turned over baking in dry 2 hours, granule is through 16 eye mesh screen granulate;
(2) captopril 2.55kg, microcrystalline Cellulose 2.5kg stir, and cross 16 mesh sieves, and dry-pressing granulate, dry press are set roller pressure 5Mpa;
(3), add magnesium stearate 0.1kg mix homogeneously with above-mentioned two kinds of granules.
The granule yield: 97.58%, moisture: 1.54, particle size distribution is as follows:
Particle diameter: order | Distribute: % |
?≤20 | ?6.39 |
?20~40 | ?34.40 |
?40~60 | ?13.07 |
?60~80 | ?4.96 |
?80~100 | ?19.80 |
?≥100 | ?19.16 |
Claims (6)
1. a pharmaceutical composition that contains captopril is characterized in that, component and weight percent content comprise:
Captopril 0.5~1.5%
Microcrystalline Cellulose 0.5~1.5%
Lactose 2~3.5%
Starch 0.1~1%
Hyprolose 0.1~1%
Pregelatinized Starch 0.1~1%
Magnesium stearate 0.01~0.1%
30 POVIDONE K 30 BP/USP 30 (PVP.k30) 91~96.69%.
2. the pharmaceutical composition that contains captopril according to claim 1 is characterized in that, component and weight percent content comprise:
Captopril 1.0%
Microcrystalline Cellulose 1.0%
Lactose 2.7%
Starch 0.50
Hyprolose 0.40
Pregelatinized Starch 0.55%
Magnesium stearate 0.05%
30 POVIDONE K 30 BP/USP 30 (PVP.k30) 93.8%.
3. the preparation of drug combination method that contains captopril according to claim 1 and 2 is characterized in that comprising the steps:
(1) with lactose, starch, pregelatinized Starch, hyprolose, stirs, sieve, adopting method well known in the art to add weight percent concentration is 3~10% PVP, weight percent concentration is 45~55% alcoholic solution, and wet granulation, granule are crossed the screen cloth granulate;
(2) captopril, microcrystalline Cellulose stir, and sieve the dry-pressing granulate;
(3), add magnesium stearate, the mix homogeneously of recipe quantity with above-mentioned two kinds of granules.
4. method according to claim 3 is characterized in that, 75~85 ℃ of dryings are 2~6 hours behind the wet granulation.
5. method according to claim 4 is characterized in that, drying was turned over baking in 1~2 hour.
6. method according to claim 3 is characterized in that, dry press is set roller pressure 5-5.5Mpa.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200310108775 CN1618426A (en) | 2003-11-21 | 2003-11-21 | Medicinal composition contg. katopril, and its prepn. method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200310108775 CN1618426A (en) | 2003-11-21 | 2003-11-21 | Medicinal composition contg. katopril, and its prepn. method |
Publications (1)
Publication Number | Publication Date |
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CN1618426A true CN1618426A (en) | 2005-05-25 |
Family
ID=34758717
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN 200310108775 Pending CN1618426A (en) | 2003-11-21 | 2003-11-21 | Medicinal composition contg. katopril, and its prepn. method |
Country Status (1)
Country | Link |
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CN (1) | CN1618426A (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102512656A (en) * | 2011-12-27 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Quinapril hydrochloride medicinal composition |
CN105362233A (en) * | 2015-12-07 | 2016-03-02 | 黑龙江省智诚医药科技有限公司 | Sustained-release captopril micro-pill and method for preparing same |
CN110623932A (en) * | 2019-10-29 | 2019-12-31 | 仁和堂药业有限公司 | Captopril tablets and application thereof |
CN110638773A (en) * | 2019-10-29 | 2020-01-03 | 仁和堂药业有限公司 | Production method of captopril tablets |
-
2003
- 2003-11-21 CN CN 200310108775 patent/CN1618426A/en active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102512656A (en) * | 2011-12-27 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Quinapril hydrochloride medicinal composition |
CN105362233A (en) * | 2015-12-07 | 2016-03-02 | 黑龙江省智诚医药科技有限公司 | Sustained-release captopril micro-pill and method for preparing same |
CN110623932A (en) * | 2019-10-29 | 2019-12-31 | 仁和堂药业有限公司 | Captopril tablets and application thereof |
CN110638773A (en) * | 2019-10-29 | 2020-01-03 | 仁和堂药业有限公司 | Production method of captopril tablets |
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PB01 | Publication | ||
C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
WD01 | Invention patent application deemed withdrawn after publication |