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Clopidogrel hydrogen sulphate tablets and preparation method thereof

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate, which is applied in the fields of pharmaceutical formula, drug delivery, blood diseases, etc., and can solve the problems of poor solubility, difficulty in disintegration and dissolution of clopidogrel bisulfate, etc. Achieve the effects of high dissolution, high production efficiency and high product yield

Inactive Publication Date: 2015-12-02
HAINAN KIRGEN BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the prior art, clopyrrole hydrogen sulfate has poor solubility and is difficult to disintegrate and dissolve

Method used

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  • Clopidogrel hydrogen sulphate tablets and preparation method thereof
  • Clopidogrel hydrogen sulphate tablets and preparation method thereof
  • Clopidogrel hydrogen sulphate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The preparation specification of embodiment 1 clopidogrel bisulfate tablet is 75 mg (calculated by clopidogrel)

[0020] Table 1 is calculated per 1000 pieces

[0021]

[0022]

[0023] Preparation process: Pass clopidogrel hydrogen sulfate, hydroxypropyl cellulose, hydrogenated castor oil, and silicon dioxide through a 80-mesh sieve and disperse microcrystalline cellulose through a 60-mesh sieve, respectively weigh the above-mentioned raw and auxiliary materials according to the prescription amount, and set aside. First mix clopidogrel bisulfate, hydroxypropyl cellulose, silicon dioxide and microcrystalline cellulose in advance, then add hydrogenated castor oil and mix evenly, the powder is directly compressed into tablets to obtain plain tablets, and Opadry is formulated into 16% Aqueous solution, the weight of the coating is increased to 1%, and the product is obtained.

[0024] Measure the clopidogrel bisulfate agent prepared by the embodiment of the inventio...

Embodiment 2

[0027] The preparation specification of embodiment 2 clopidogrel bisulfate tablet is 75mg (according to clopidogrel)

[0028] Table 3 is calculated per 1000 pieces

[0029]

[0030] Preparation process: Pass clopidogrel hydrogen sulfate, hydroxypropyl cellulose, hydrogenated castor oil, and silicon dioxide through a 80-mesh sieve and disperse microcrystalline cellulose through a 60-mesh sieve, respectively weigh the above-mentioned raw and auxiliary materials according to the prescription amount, and set aside. First mix clopidogrel bisulfate, hydroxypropyl cellulose, silicon dioxide and microcrystalline cellulose in advance, then add hydrogenated castor oil and mix evenly, the powder is directly compressed into tablets to obtain plain tablets, and Opadry is formulated into 16% Aqueous solution, the weight of the coating is increased to 1%, and the product is obtained.

[0031] Measure the clopidogrel bisulfate prepared by the embodiment of the invention 2 according to the...

Embodiment 3

[0034] Example 3 Preparation of Clopidogrel Hydrogen Sulfate Tablet Specifications 75mg (calculated as clopidogrel)

[0035] Table 5 is calculated per 1000 pieces

[0036]

[0037] Preparation process: Pass clopidogrel hydrogen sulfate, hydroxypropyl cellulose, hydrogenated castor oil, and silicon dioxide through a 80-mesh sieve and disperse microcrystalline cellulose through a 60-mesh sieve, respectively weigh the above-mentioned raw and auxiliary materials according to the prescription amount, and set aside. First mix clopidogrel bisulfate, hydroxypropyl cellulose, silicon dioxide and microcrystalline cellulose in advance, then add hydrogenated castor oil and mix evenly, the powder is directly compressed into tablets to obtain plain tablets, and Opadry is formulated into 16% Aqueous solution, the weight of the coating is increased to 1%, and the product is obtained.

[0038] Measure the clopidogrel bisulfate prepared by the embodiment of the invention 3 according to the ...

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PUM

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Abstract

The invention relates to clopidogrel hydrogen sulphate tablets. The clopidogrel hydrogen sulphate tablets are prepared from the following raw materials in percentage by weight: 30-43% of clopidogrel hydrogen sulfate, 15-45% of diluents, 5-30% of disintegrant, 0.1-8% of lubricant, 0.1-2% of glidants and 1-4% of powder for coating. The tablets are dissolved rapidly and released uniformly. The invention also relates to a preparation method of the clopidogrel hydrogen sulphate tablets. The preparation method comprises the following steps of mixing, tabletting and coating. The preparation method is simple and practicable; and the quality of prepared finished products is stable.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a tablet and a preparation method thereof. Background technique [0002] Population growth and aging will increase the incidence of cardiovascular disease in China by more than 50% in the next 20 years, and current risk factors such as high blood pressure, total cholesterol, diabetes and obesity will accelerate the upward trend of cardiovascular disease . Thromboembolic disease is a common and frequently-occurring disease in humans, which endangers human health. Cardiovascular intima injury, slowed blood flow, increased blood coagulation can lead to thrombosis. Clopidogrel is a platelet aggregation inhibitor that selectively inhibits the binding of adenosine diphosphatase (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb / IIIa complex. Can inhibit platelet aggregation. At present, aspirin is the most commonly used in the clini...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4365A61P7/02
Inventor 朱一明张琼海谢建新姚一飞
Owner HAINAN KIRGEN BIOPHARM CO LTD
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