Clopidogrel sulfate solid preparation, and its preparing method

A technology of clopidogrel sulfate and solid preparations, which is applied in the field of solid preparations of medicines and its preparation, and can solve problems such as clopidogrel levorotary substances that have not been solved, and achieve the effect of improving clinical safety and stability

Active Publication Date: 2008-07-09
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the problem of controlling the content of clopidogrel levorotate has not been resolved

Method used

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  • Clopidogrel sulfate solid preparation, and its preparing method
  • Clopidogrel sulfate solid preparation, and its preparing method
  • Clopidogrel sulfate solid preparation, and its preparing method

Examples

Experimental program
Comparison scheme
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Embodiment Construction

[0034] 1. Tablet prescription with a unit tablet weight of 0.175g and a clopidogrel content of 25mg / tablet and the preparation process of the grinding equivalent incremental method

[0035] composition

Content (g)

Clopidogrel Bisulfate

32.6

anhydrous lactose

64.78

pregelatinized starch

41.0

Polyglyceryl Stearate

56.17

Sodium carboxymethyl starch

19.27

Micropowder silica gel

10.91

Glyceryl Palmitate Stearate

2.75

[0036] 1) Mix 32.6 g of clopidogrel hydrogen sulfate and 56.17 g of polyglyceryl stearate evenly, press into tablets, crush the obtained tablets and pass through a 60-mesh sieve.

[0037] 2) Fully mix the granules obtained in operation 1) with 64.78 g of anhydrous lactose, 41.0 g of pregelatinized starch and 10.91 g of micropowdered silica gel, and press the tablets into tablets, crush the obtained tablets and pass through a 40-60 mesh sieve.

[0038] 3), th...

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Abstract

The present invention relates to a solid preparation of clopidogrel hydrochloride and its preparation method. It is characterized by that in said sold preparation the palmitoleostearin and micropowder silica gel are added, and its preparation method adopts a grinding equivalent progressively-increasing method so as to raise the stability and safety of said solid preparation.

Description

[technical field] [0001] The invention relates to a solid preparation of medicine and a preparation method thereof, in particular to a solid preparation of clopidogrel sulfate and a method for preparing the solid preparation by a grinding equivalent increment method. [Background technique] [0002] Clopidogrel is an inducible platelet aggregation inhibitor that acts by inhibiting the binding of adenosine monophosphate to its receptors. Clopidogrel is an inactive prodrug that is metabolized by hepatic cytochrome P450 into an active metabolite to exert its drug effect. Patents FR2215948 and FR2530247 disclose that clopidogrel has significant anti-platelet aggregation and antithrombotic effects. Clopidogrel reduces the chance of arterial blockage by inhibiting platelet aggregation, achieves the effect of preventing stroke and heart attack, and can effectively treat and prevent atherosclerosis. [0003] Clopidogrel is usually given in its sulfate form. Its structure is as fol...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/00A61K31/4365A61K47/06A61J3/10A61P7/02
Inventor 叶澄海
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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