Solid pharmaceutical composition with clopidogrel

Abstract

In order to overcome shortcomings of material sticking of a clopidogrel crude drug and hydrolysis of the crude drug in a preparation thereof in storage, the invention designs a solid pharmaceutical composition with clopidogrel and provides a prescription and a process for further preparing the solid pharmaceutical composition into a tablet. The tablet has good forming property and is capable of inhibiting hydrolysis of the crude drug in the process of existence; and unexpectedly, the tablet also inhibits mutarotation of the crude drug. The tablet of the invention is simple in preparation method and can be manufactured by conventional preparation methods without special devices, so that the tablet has the advantages of easy industrialization, high production efficiency, good stability and controllable quality. Thus the solid pharmaceutical composition has outstanding substantive features and obvious inventive steps.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a solid pharmaceutical composition containing clopidogrel, a preparation method and application thereof. Background technique [0002] Cardiovascular and cerebrovascular thrombotic disease is a common disease in my country and an important cause of death for our people. The average incidence of myocardial infarction in my country is about 42 per 100,000 people; and with the improvement of nutritional status, the incidence is increasing. my country is also an area with a high incidence of cerebral thrombosis patients. At present, the number of patients has exceeded 8 million. There are about 1.5 million new cases each year, and more than 1 million deaths each year. Among the survivors, about 25% of them lose their labor force to varying degrees. Among them, severe disability is as high as 40%. Currently, clopidogrel and aspirin are the mainstream drugs for antithromb...

AI Technical Summary

Problems solved by technology

[0028] This shows, in order to solve the problem of sticking and rushing in the process of preparing clopidogrel bisulfate tablet, and the degradation and the mutarotation problem in the preparation storage process, people have proposed a lot of solutions, but there are certain defects, such as No wet granulation, complex operation, high production cost, etc.

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