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Method for preparing enalapril maleate tablets

A kind of technology of enalapril maleate and Pulee tablets, which is applied in the field of preparation of enalapril maleate tablets, can solve problems such as unreasonable and difficult industrial production, and achieve simple preparation process and ensure storage The effect of stability

Inactive Publication Date: 2019-02-19
SHANDONG POLYTECHNIC COLLEGE +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent (201710208383.5) discloses a method for preparing enalapril maleate tablets, which is produced by drying under reduced pressure, which is difficult for industrial production
Chinese patent (201510655667) uses L-arginine as a stabilizer, and uses a solid mixing method to stabilize enalapril maleate. L-arginine as an active ingredient should be fully clinically tested, simply as It is unreasonable to add excipients to enalapril maleate tablets
[0007] The purpose of this invention is to provide a kind of preparation method of enalapril maleate tablet, solve its stability problem, improve the effectiveness and safety of product

Method used

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  • Method for preparing enalapril maleate tablets

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Comparison scheme
Effect test

Embodiment

[0018] Specification: 5mg

[0019] prescription:

[0020] Material name

[0021] Preparation Process:

[0022] ① Make a solution of 1g of sodium bicarbonate with 30ml of water.

[0023] ②Dissolve 5.0g of raw materials in sodium bicarbonate solution, and stir until the solution is clear and transparent.

[0024] ③ Add 30.0g of pre-crossed starch and 82.5g of lactose monohydrate into the wet granulator and mix at 70rpm for 10 minutes, and mix well.

[0025] ④Add the solution in step ② as a binder to the solution in step ③, stir at 70rpm, and mix evenly with a cutter at 1500rpm.

[0026] ⑤ Granulate the material in step ④ with 16 mesh, put it into a fluidized bed for drying, control the inlet air temperature at 55°C, set the fan frequency at 20HZ, and dry to a moisture content of 2.5%.

[0027] ⑥Add 1.5g of magnesium stearate to the dried material, mix well, and press into tablets.

[0028] Stability test results:

[0029]

[0030] The enalapril maleate ...

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Abstract

The invention relates to a method for preparing enalapril maleate tablets, and belongs to the field of pharmaceutical preparations. The method for preparing the stable enalapril maleate tablets is discovered pertinently for the problems of increase of related substances in enalapril maleate tablet long-term storage procedures and instable quality of products. The method for preparing the enalaprilmaleate tablets has the advantages that the method is simple, industrial production can be facilitated, and the quality of products can be guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of enalapril maleate tablets. Background technique [0002] Enalapril maleate chemical name: n-[(s)-1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-L-proline (Z)-2- Butenedioate, molecular formula: C 24 h 32 N 2 o 9 , molecular weight: 492.52, structural formula: [0003] [0004] Pharmacological action: This product is an angiotensin-converting enzyme inhibitor, which is hydrolyzed into Enalaprilat in the body after oral administration. The latter inhibits angiotensin-converting enzyme, reduces the content of angiotensin II, causes systemic vasodilation, and lowers blood pressure. [0005] Enalapril maleate tablets are unstable during long-term storage, and related substances increase, and the degradation reaction is divided into two types of reactions. In the amide reaction, the carboxyl group on the pyrrole ring and the imine on the chain a...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K9/20A61K47/36A61K47/26A61K47/02A61K47/12A61P9/12
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2059A61K38/05A61P9/12
Inventor 刘登宋新鲁王猛
Owner SHANDONG POLYTECHNIC COLLEGE
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