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Enalapril maleate tablet and preparation method thereof

A technology of enalapril maleate and maleic acid, which is applied in the direction of pill delivery, cardiovascular system diseases, and active ingredients of heterocyclic compounds, can solve the problems of complicated preparation process and increased cost, and achieve simple and economical procedures The effect of cost and excellent stability

Active Publication Date: 2012-11-07
JIANGSU PENGYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Though above-mentioned five kinds of methods have strengthened the stability of enalapril maleate tablet to a certain extent, also make preparation technology more complicated, increased cost

Method used

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  • Enalapril maleate tablet and preparation method thereof
  • Enalapril maleate tablet and preparation method thereof
  • Enalapril maleate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Mix 5 g of enalapril maleate and 50 g of microcrystalline cellulose in equal increments, pass through a 100-mesh sieve, and mix the obtained powder with 30 g of microcrystalline cellulose in equal increments, pass through a 100-mesh sieve , the obtained powder is uniformly mixed with 1 g of starch in equal increments, passed through a 100-mesh sieve, and the obtained powder is uniformly mixed with 3 g of talcum powder and 0.8 g of magnesium stearate in equal increments, dry granulated and compressed into tablets, to obtain 1000 tablets of enalapril maleate.

Embodiment 2

[0030] Mix 5 g of enalapril maleate and 40 g of microcrystalline cellulose in equal increments, pass through a 100-mesh sieve, and mix the obtained powder with 25 g of microcrystalline cellulose in equal increments, pass through a 100-mesh sieve , the obtained powder was uniformly mixed with 2 g of talcum powder and 0.5 g of magnesium stearate in equal increments, dry granulated and compressed into tablets to obtain 1000 enalapril maleate tablets.

Embodiment 3

[0032] Mix 5 g of enalapril maleate and 55 g of microcrystalline cellulose in equal increments, pass through a 100-mesh sieve, and mix the obtained powder with 10 g of microcrystalline cellulose in equal increments, pass through a 100-mesh sieve , the obtained powder is uniformly mixed with 2 g of starch in equal increments, passed through a 100-mesh sieve, and the obtained powder is uniformly mixed with 3 g of talcum powder and 0.8 g of magnesium stearate in equal increments, dry granulated and compressed into tablets, to obtain 1000 tablets of enalapril maleate.

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PUM

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Abstract

The invention discloses an enalapril maleate tablet and a preparation method thereof, belonging to the technical field of chemical pharmaceutical industry. The enalapril maleate tablet mainly contains 3 to 9 parts of enalapril maleate, 40 to 60 parts of filling agent, 0 to 35 parts of disintegrating agent, 0 to 2 parts of caking agent, 0.1 to 4 parts of lubricating agent and 0.1 to 3 parts of flow aid. Compared with the conventional merchant enalapril maleate tablet, the enalapril maleate table provided by the invention adopts auxiliary materials which have poorer compatibility with the enalapril maleate technical on the traditional conception and ensures that the enalapril maleate tablet produced by using common auxiliary materials has excellent stability by utilizing the specified proportions among raw and auxiliary materials and the specific preparation process; and after being detected, the material qualities of batches of products are all not more than 3.0 percent, the quality stability thereof is superior to the same product from other enterprises, and the cost is saved to the largest extent at the same time of improving the stability.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and in particular relates to an enalapril maleate tablet and a preparation method thereof. Background technique [0002] Enalapril maleate (Enalapril maleate), the chemical name is N-[(S)-1-(ethanocarbonyl)-3-phenylpropyl]-L-alanyl-L-proline cis-butyl Acenoate, the molecular formula is C 20 h 28 N 2 o 5 ·C 4 h 4 o 4 , molecular weight 492.52, CAS registration number 76095-16-4. In 1985, FDA approved enalapril maleate unilateral tablet to go on the market. [0003] Enalapril is a second-generation angiotensin-converting enzyme inhibitor (ACEI). Unlike captopril in the first-generation ACEI, enalapril does not contain a sulfhydryl group (-SH), which reduces the first Side effects of decaptopril, such as abnormal cough, rash, proteinuria, and neutropenia. At the same time, enalapril is a prerequisite drug, which is hydrolyzed by liver enzymes into enalaprilate in the body to play ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/40A61P9/12
Inventor 王春林吴洪君孙瑶钱耀军
Owner JIANGSU PENGYAO PHARMA
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