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Clopidogrel bisulfate medicine composition and preparation method

A technology of clopidogrel bisulfate and composition, which is applied in the field of clopidogrel bisulfate pharmaceutical composition and preparation, can solve the problems of inability to wet granulate, high production cost, complicated operation, etc., achieve cheap excipients, and solve sticky punching Problems, the effect of simple preparation process

Active Publication Date: 2012-06-27
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that, in order to solve the problem of sticking and punching in the process of preparing clopidogrel bisulfate tablets, people have proposed a lot of solutions, but there are certain defects, such as inability to wet granulation, complicated operation, high production cost, etc.

Method used

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  • Clopidogrel bisulfate medicine composition and preparation method
  • Clopidogrel bisulfate medicine composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: the preparation process of clopidogrel bisulfate tablet

[0026] Group ratio:

[0027] Name of raw material 1000 tablets dosage Clopidogrel bisulfate 97.9g microcrystalline cellulose 120g Crospovidone 7.5g Glyceryl behenate 5g talcum powder 7.5g

[0028] Preparation:

[0029] (1) Crush the clopidogrel bisulfate, pass through an 80-mesh sieve, and set aside.

[0030] (2) Pass the microcrystalline cellulose through an 80-mesh sieve, and dry at 105°C for 2 hours for later use.

[0031] (3) Mix the above clopidogrel hydrogen sulfate and microcrystalline cellulose evenly, add an appropriate amount of ethanol solution to granulate.

[0032] (4) Dry the wet granules prepared above at 50°C, and control the moisture content of the granules below 3%.

[0033] (5) Sieve the dry granules for granulation, add croscarmellose sodium, glyceryl behenate, and talcum powder at the same time, mix evenly, and select a suitable ...

Embodiment 2

[0034] Embodiment 2: the preparation process of clopidogrel bisulfate tablet

[0035] Group ratio:

[0036] Name of raw material 1000 tablets dosage Clopidogrel bisulfate 97.9g microcrystalline cellulose 250g Crospovidone 30g Glyceryl behenate 4g talcum powder 4.5g

[0037] Preparation:

[0038] (1) Crush clopidogrel hydrogen sulfate, pass through a 200-mesh sieve, and set aside.

[0039] (2) Pass the microcrystalline cellulose through an 80-mesh sieve, and dry at 105°C for 2 hours for later use.

[0040] (3) Mix the above clopidogrel hydrogen sulfate and microcrystalline cellulose evenly, add an appropriate amount of ethanol solution to granulate.

[0041] (4) Dry the wet granules prepared above at 50°C, and control the moisture content of the granules below 3%.

[0042] (5) Sieve the dry granules for granulation, add croscarmellose sodium, glyceryl behenate, and talcum powder at the same time, mix evenly, and select a suitabl...

Embodiment 3

[0043] Embodiment 3: the preparation process of clopidogrel bisulfate tablet

[0044] Group ratio:

[0045] Name of raw material 1000 tablets dosage Clopidogrel bisulfate 97.9g microcrystalline cellulose 65g Crospovidone 5g Glyceryl behenate 2g talcum powder 3g

[0046] Preparation:

[0047] (1) Crush clopidogrel hydrogen sulfate, pass through a 200-mesh sieve, and set aside.

[0048] (2) Pass Starch 1500 through an 80-mesh sieve, and dry at 105°C for 2 hours for later use.

[0049] (3) Mix the above clopidogrel hydrogen sulfate and microcrystalline cellulose evenly, add an appropriate amount of ethanol solution to granulate.

[0050] (4) Dry the wet granules prepared above at 50°C, and control the moisture content of the granules below 3%.

[0051] (5) Sieve the dry granules for granulation, add crospovidone, glyceryl behenate, and talcum powder at the same time, mix evenly, and select a suitable pressure for tableting.

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Abstract

The invention relates to a clopidogrel bisulfate medicine composition and a preparation method. The composition contains clopidogrel bisulfate, as well as proper filler, disintegrant and lubricant, wherein the content of the clopidogrel bisulfate is 25-60%, the content of the filler is 35-65%, the content of the disintegrant is 2.5-8%, and the content of the lubricant is 2-6%. Additionally, the invention further provides a preparation method for preparing tablets from the composition. Each component in the composition disclosed by the invention is good in compatibility, low in price and easy to get; and the preparation for tablets is simple in process and without the need to add new equipment, capable of efficiently solving the problem of sticking appearing during preparation process, andsuitable for industrialized production.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a clopidogrel bisulfate pharmaceutical composition and a preparation method. Background technique [0002] The chemical name of clopidogrel hydrogen sulfate is 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5-yl)acetic acid methyl ester hydrogen sulfate, which The structural formula is as follows: [0003] [0004] Clopidogrel bisulfate is a new type of high-efficiency antiplatelet drug, which is clinically used in the treatment of atherosclerotic diseases, acute coronary syndrome, and the prevention of in-stent restenosis and thrombotic complications after coronary stent implantation wait. Clopidogrel bisulfate can selectively inhibit the binding of adenosine diphosphate (ADP) to platelet receptors and the subsequent ADP-mediated activation of the glycoprotein GPlllb / llla complex, thus inhibiting platelet aggregation. In addition to ADP, clopidogrel bisulfate also inhibits ...

Claims

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Application Information

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IPC IPC(8): A61K31/4365A61K9/20A61P7/02A61P9/10
Inventor 张栋贡肖巍臧隽忻陈明强李后涛刘杰牛海岗
Owner SHANDONG QIDU PHARMA
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