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Tablet containing clopidogrel hydrogen sulfate and preparation method thereof

A technology of clopidogrel bisulfate and clopidogrel bisulfate pellets, which is applied in the directions of pill delivery, blood diseases, extracellular fluid diseases, etc., can solve the problem of stability of clopidogrel bisulfate tablets, which cannot be solved at the same time. problems, etc., to achieve good stability

Active Publication Date: 2013-03-20
ZHEJIANG ANGLIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the fact that prior art cannot simultaneously solve the stability problem of clopidogrel bisulfate tablet and the sticking problem in the production process, the object of the present invention is to provide a kind of tablet containing clopidogrel bisulfate and preparation method thereof, with Overcome the shortcomings of the existing technology

Method used

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  • Tablet containing clopidogrel hydrogen sulfate and preparation method thereof
  • Tablet containing clopidogrel hydrogen sulfate and preparation method thereof
  • Tablet containing clopidogrel hydrogen sulfate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Clopidogrel Bisulfate Tablet Formulation:

[0038]

[0039] Preparation Process:

[0040] ① Add clopidogrel bisulfate, microcrystalline cellulose and mannitol to 10% hydroxypropyl cellulose in absolute ethanol solution to make soft material, wet granules after sieving with 20 meshes;

[0041] ②Put the wet particles in the shot blasting machine, adjust the rotation speed of the turntable at the bottom of the shot blasting machine to 800rpm, and the blower frequency at 10HZ, and the particles are fluidized and rounded in the fluidized bed for about 5 minutes, and the material is discharged, and after fluidized drying, hydrochloric acid hydrogen sulfate is obtained. Pidogrel pellets;

[0042] ③Using hydroxypropyl methylcellulose as the coating material to prepare a coating liquid, and to coat the clopidogrel bisulfate pellets;

[0043] ④ The coated clopidogrel bisulfate pellets were mixed with magnesium stearate and pressed into tablets, and no sticking phenomenon occ...

Embodiment 2

[0045] Clopidogrel Bisulfate Tablet Formulation:

[0046]

[0047] Preparation Process:

[0048] ① Add clopidogrel bisulfate, microcrystalline cellulose and mannitol to 10% hydroxypropyl cellulose in absolute ethanol solution to make soft material, wet granules after sieving with 20 meshes;

[0049] ②Put the wet particles in the shot blasting machine, adjust the rotation speed of the turntable at the bottom of the shot blasting machine to 900rpm, and the blower frequency at 15HZ. The particles are fluidized and rounded in the fluidized bed for about 6 minutes, and the material is discharged, and after fluidized drying, hydrochloric acid hydrogen sulfate is obtained. Pidogrel pellets;

[0050] ③Using hydroxypropyl methylcellulose as the coating material to prepare a coating liquid, and to coat the clopidogrel bisulfate pellets;

[0051] ④ The coated clopidogrel bisulfate pellets were mixed with magnesium stearate and pressed into tablets, and no sticking phenomenon occurred....

Embodiment 3

[0053] Clopidogrel Bisulfate Tablet Formulation:

[0054]

[0055]

[0056] Preparation Process:

[0057] ① Add clopidogrel bisulfate, microcrystalline cellulose and mannitol to 8% hydroxypropyl cellulose in absolute ethanol solution to make soft material, wet granules after sieving with 20 meshes;

[0058] ②Put the wet particles in the shot blasting machine, adjust the rotation speed of the turntable at the bottom of the shot blasting machine to 800rpm, and the blower frequency at 15HZ, and the particles are fluidized and rounded in the fluidized bed for about 8 minutes, and the material is discharged, and after fluidized drying, hydrochloric acid hydrogen sulfate is obtained. Pidogrel pellets;

[0059] ③Using hydroxypropyl methylcellulose as the coating material to prepare a coating liquid, and to coat the clopidogrel bisulfate pellets;

[0060] ④ The coated clopidogrel bisulfate pellets were mixed with magnesium stearate and pressed into tablets, and no sticking phe...

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Abstract

The invention discloses a tablet containing clopidogrel hydrogen sulfate. The tablet comprises clopidogrel hydrogen sulfate micropills which are prepared into tablets through coating; the micropills are prepared by clopidogrel hydrogen sulfate, a diluent and an adhesion agent; the diluent is mannitol or / and microcrystalline cellulose; the adhesion agent is an anhydrous ethanol solution of hydroxypropylcellulose or povidone; and an lubricating agent is one or more of magnesium stearate, zinc stearate, talc, polyethylene glycol 6000, stearic acid, sodium stearyl fumarate, sodium lauryl sulfate and hydrogenated vegetable oil.

Description

technical field [0001] The invention relates to an oral solid preparation containing anti-platelet aggregation drugs, in particular to a tablet containing clopidogrel bisulfate and a preparation method thereof. Background technique [0002] Cardiovascular and cerebrovascular thrombotic disease is a common disease in my country and an important cause of death in China. 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 antithrombotic thera...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4365A61K47/38A61P7/02A61P9/10A61P9/14
Inventor 方南平杨国栋徐成苗严立勇周军
Owner ZHEJIANG ANGLIKANG PHARMA
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