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Enalapril maleate preparation and application thereof

A technology of enalapril maleate and preparations, which is applied in the field of enalapril maleate preparations, can solve the problems of the influence of drug impurities and the pH microenvironment of the preparation prescription, and achieve enhanced stability and improved bioavailability , the effect of less impurities

Active Publication Date: 2018-04-24
湖南千金湘江药业股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus affecting the pH microenvironment in the preparation prescription, it will eventually have a certain impact on the production of drug impurities

Method used

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  • Enalapril maleate preparation and application thereof
  • Enalapril maleate preparation and application thereof
  • Enalapril maleate preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0056] A kind of enalapril maleate preparation, its composition and consumption are as shown in table 1 (wherein percentage represents the massfraction of this composition in enalapril maleate preparation):

[0057] Table 1 Enalapril maleate preparation composition and dosage data

[0058]

[0059] Note: A and B are the components of the stabilizer respectively, and the total mass of A and B accounts for 5.0% of the weight of the entire enalapril maleate formulation prescription tablet.

[0060] Stabilizer composition (pH is measured by dissolving stabilizer in water):

[0061] 1) Disodium hydrogen phosphate (A) – citric acid (B): Among them, disodium hydrogen phosphate can choose anhydrous disodium hydrogen phosphate or dihydrate disodium hydrogen phosphate, and citric acid can choose monohydrate citric acid, and the obtained different ratios Disodium hydrogen phosphate (A) - citric acid (B) system and corresponding pH are shown in Table 2:

[0062] Table 2 pH data of di...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to an enalapril maleate preparation and application thereof. PH of the enalapril maleate preparation is 6.4-7.4. By controlling pH of enalapril maleate preparation, stability of the enalapril maleate preparation can be effectively enhanced, impurities such as DPK (diketopiperazine), enalaprilat, N-[1-(S)-(ethoxycarbonyl)-3-phenylpropyl]-L-alanine (impurity B) and the like generated by degradation of enalapril maleate in the enalapril maleate preparations in different dosage forms such as powder, granulesand tablets can be effectively controlled, bioavailability is fully improved, and the preparation can be used for preparing angiotensin converting enzyme inhibitor drugs.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation of enalapril maleate and applications thereof. Background technique [0002] Usually, the stability of a pharmaceutical composition is a very important consideration during the design, manufacture, and storage of the pharmaceutical composition. Drugs with poor stability may be degraded into certain degradation products, causing unnecessary side effects or reducing the efficacy or bioavailability of the drug itself, making it difficult to achieve satisfactory results. [0003] The chemical name of enalapril maleate is N-[(S)-1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-L-proline butene Diacid salt, molecular formula C 20 h 28 N 2 o 5 C 4 h 4 o 4 , molecular weight 492.52, CAS No. 76095-16-4, its acid-base dissociation constant is shown below. In 1985, the FDA approved enalapril maleate unilateral tablet to go on the market. [0004] ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/40A61K47/24A61K47/18A61K47/12A61K47/02A61P9/12
CPCA61K9/00A61K31/40A61K47/02A61K47/12A61K47/183A61K47/24
Inventor 宿亮姚亮元袁红波袁秀菊钟爱军王雪姣陈涛吴超男郭伟王玲兰
Owner 湖南千金湘江药业股份有限公司
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