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Clopidogrel hydrochloride tablet

A technology of clopidogrel hydrochloride and polyvinylpyrrolidone, applied in the field of clopidogrel hydrochloride tablets and its preparation, can solve the problems of poor stability of clopidogrel and easy sticking in the production process, etc.

Active Publication Date: 2013-10-09
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a pharmaceutical composition with clopidogrel hydrochloride salt as an active ingredient, which effectively solves the problems of poor stability of clopidogrel and easy sticking during production.

Method used

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  • Clopidogrel hydrochloride tablet
  • Clopidogrel hydrochloride tablet
  • Clopidogrel hydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1: tablet

[0058]

[0059]

[0060] Preparation:

[0061] Clopidogrel hydrochloride was crushed through a 100-mesh sieve, polyethylene glycol 6000 and silicon dioxide were respectively passed through a 100-mesh sieve, polyvinylpyrrolidone, mannitol, and low-substituted hydroxypropyl cellulose were respectively passed through a 80-mesh sieve, and hydrogenated castor oil was passed through a 100-mesh sieve Sieve; after mixing 60% silicon dioxide and clopidogrel hydrochloride, add polyethylene glycol 6000, polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose and mannitol and mix evenly in equal amounts; granulate, and calculate the dryness Granule yield, add hydrogenated castor oil and the remaining 40% of silicon dioxide, mix for 15-20 minutes, compress into tablets, and coat.

Embodiment 2

[0062] Embodiment 2: tablet

[0063]

[0064] Preparation:

[0065] Clopidogrel hydrochloride was crushed through a 100-mesh sieve, polyethylene glycol 6000 and silicon dioxide were respectively passed through a 100-mesh sieve, polyvinylpyrrolidone, mannitol, and low-substituted hydroxypropyl cellulose were respectively passed through a 80-mesh sieve, and hydrogenated castor oil was passed through a 100-mesh sieve Sieve; after mixing 60% silicon dioxide and clopidogrel hydrochloride, add polyethylene glycol 6000, low-substituted hydroxypropyl cellulose, polyvinylpyrrolidone and mannitol and mix in equal increments; granulate, Calculate the yield of dry granules, add hydrogenated castor oil and the remaining 40% of silicon dioxide, mix for 15 minutes, compress into tablets, and coat.

Embodiment 3

[0066] Embodiment 3: tablet

[0067]

[0068]

[0069] Preparation:

[0070]Clopidogrel hydrochloride was crushed through a 100-mesh sieve, polyethylene glycol 6000 and silicon dioxide were respectively passed through a 100-mesh sieve, polyvinylpyrrolidone, mannitol, and low-substituted hydroxypropyl cellulose were respectively passed through a 80-mesh sieve, and hydrogenated castor oil was passed through a 100-mesh sieve Sieve; after mixing 60% silicon dioxide and clopidogrel hydrochloride, add polyethylene glycol 6000, low-substituted hydroxypropyl cellulose, polyvinylpyrrolidone and mannitol and mix in equal increments; granulate, Calculate the yield of dry granules, add hydrogenated castor oil and the remaining 40% of silicon dioxide, mix for 5 minutes, compress into tablets, and coat.

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Abstract

The invention relates to a clopidogrel hydrochloride tablet which comprises clopidogrel hydrochloride or salts thereof and pharmaceutically acceptable excipients. The clopidogrel hydrochloride tablet is stable and controllable in quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a clopidogrel hydrochloride tablet and a preparation method thereof. Background technique [0002] Clopidogrel [2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5-yl)methyl acetate hydrochloride] is an ADP receptor inhibitor It can bind to the ADP receptor on the surface of the platelet membrane, so that fibrinogen cannot bind to the glycoprotein GPⅡb / Ⅲa receptor, thereby inhibiting the mutual aggregation of platelets. [0003] This product is the hydrochloride of clopidogrel, which has been marketed as the bisulfate of clopidogrel, and its active ingredients are the same. Regardless of preclinical effectiveness and safety, or clinical trial effectiveness and safety, they are similar to the marketed product Plavix. [0004] Clopidogrel has been widely used in the treatment of acute cerebral infarction, unstable angina, acute ischemic stroke, acute myocardial infa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4365A61K47/44A61K9/28A61P7/02
Inventor 董凯何晓娟王瑞卿李宝齐
Owner TIANJIN CHASE SUN PHARM CO LTD
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