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A kind of tablet containing amlodipine besylate L-body or racemate and preparation method thereof

A technology of amlodipine besylate and tablets, which is applied to medical preparations containing active ingredients, medical preparations without active ingredients, pill delivery, etc., can solve problems such as complex preparation processes, and achieve uniform drug content, The particle size requirement is not harsh and the preparation method is simple

Active Publication Date: 2017-10-24
浙江得恩德制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method improves stability, the preparation process is complicated

Method used

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  • A kind of tablet containing amlodipine besylate L-body or racemate and preparation method thereof
  • A kind of tablet containing amlodipine besylate L-body or racemate and preparation method thereof
  • A kind of tablet containing amlodipine besylate L-body or racemate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027]

[0028] Preparation:

[0029] Mix the prescribed amount of amlodipine besylate and copovidone S630 evenly, heat under stirring at 60°C until the copovidone S630 melts, cool to 25°C, and solidify for 10 hours to obtain a drug-containing mixture; After a 60-mesh sieve, it is evenly mixed with lactose, microcrystalline cellulose, crospovidone and magnesium stearate in the prescribed amount, and then compressed into tablets.

Embodiment 2

[0031]

[0032] Preparation:

[0033] Mix the prescribed amount of amlodipine besylate and copovidone S630 evenly, heat under stirring at 63°C until the copovidone S630 melts, cool to 20°C, and solidify for 9 hours to obtain a drug-containing mixture; After the 50-mesh sieve, it is evenly mixed with the prescribed amount of microcrystalline cellulose, crospovidone and magnesium stearate, and then compressed into tablets.

Embodiment 3

[0035]

[0036] Preparation:

[0037] Mix the prescribed amount of amlodipine besylate and copovidone S630 evenly, heat under stirring at 62°C until the copovidone S630 melts, cool to 25°C, and solidify for 10 hours to obtain a drug-containing mixture; After a 60-mesh sieve, mix evenly with the prescribed amount of microcrystalline cellulose, crospovidone, and magnesium stearate, and compress into tablets.

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PUM

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Abstract

The invention discloses an amlodipine besylate tablet, wherein the amlodipine besylate is a levorotatory form or a racemic form, and the tablet is prepared by mixing a drug-containing mixture with other pharmaceutically acceptable auxiliary materials. It is directly compressed into tablets after uniformity, and the drug-containing mixture is obtained by mixing amlodipine besylate and copovidone S630, heating until the copovidone S630 melts, and then cooling and solidifying. Compared with the prior art, the preparation of the invention has rapid drug dissolution, uniform content, stable quality, simple preparation process, no complicated preparation equipment, and easy industrialized mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid oral preparation, in particular to a tablet containing amlodipine besylate L-isomer or racemate and a preparation method thereof. Background technique [0002] Calcium antagonists (CAS) are recognized as effective antihypertensive drugs and arterial dilators, which prevent Ca by blocking specific L-type calcium channels on myocardial and vascular smooth muscle cells. 2+ Into the cells, thereby relaxing vascular smooth muscle, expanding peripheral arterioles, reducing peripheral resistance, and lowering blood pressure. In addition, calcium antagonists can also help improve myocardial ischemia and relieve angina by reducing cardiac afterload and increasing coronary blood flow. [0003] Amlodipine besylate is the third-generation 1,4-dihydropyridine calcium ion antagonist successfully developed by Pfizer Pharmaceuticals Co., Ltd. in the mid-1...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/32A61P9/12A61P9/10
Inventor 刘法千金春晖鲍立曾潘六富
Owner 浙江得恩德制药股份有限公司
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