Pharmaceutical composition containing enalapril and preparation method thereof

A technology of enalapril and composition, applied in the field of pharmaceutical composition containing enalapril and its preparation, can solve problems such as instability of the preparation, and achieve the effect of solving fluidity, good stability, and good stability

Pending Publication Date: 2015-10-21
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this patent provides a preparation method for enalapril maleate oral liquid and a solution to ensure the stability of the liquid preparation, it still has disadvantages that cannot be ignored
We know that enalapril maleate itself is quite stable under conditions such as high temperature, high humidity, and strong light, but enalapril maleate preparations are relatively unstable, and the influence of excipients is the key
Although the above-mentioned patent provides a method for preparing enalapril maleate oral liquid, its solid powder packaging can only guarantee the stability of 6 months, and the reconstituted liquid solution can only guarantee the stability of 12 weeks

Method used

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  • Pharmaceutical composition containing enalapril and preparation method thereof
  • Pharmaceutical composition containing enalapril and preparation method thereof
  • Pharmaceutical composition containing enalapril and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 contains the liquid pharmaceutical composition of enalapril

[0039] A liquid pharmaceutical composition containing enalapril, the components and their contents are as follows:

[0040]

[0041]

[0042] The preparation method of this liquid pharmaceutical composition is as follows:

[0043] Take enalapril maleate raw material drug 1000g and dissolve in ethanol, add 1.0g silicon dioxide at the same time, spray dry to 60-180 mesh solid particles, divide into 10000 parts. When using, dissolve one part of solid particles with one part of diluent, first take part of the diluent and add to the solid particles, shake to fully dissolve the solid particles, then add the remaining diluent, shake and mix evenly.

Embodiment 2

[0044] Embodiment 2 contains the liquid pharmaceutical composition of enalapril

[0045] A liquid pharmaceutical composition containing enalapril, the components and their contents are as follows:

[0046]

[0047] The preparation method of this liquid pharmaceutical composition is as follows:

[0048] Get enalapril maleate crude drug 1000g, add 2.51g silicon dioxide, mix well, and pack into 10000 parts. When using, use one part of diluent to dissolve one part of solid powder, first take part of the diluent and add it to the solid powder, shake to fully dissolve the solid powder, then add the remaining diluent, shake and mix evenly.

Embodiment 3

[0049] Embodiment 3 contains the liquid pharmaceutical composition of enalapril

[0050] A liquid pharmaceutical composition containing enalapril, the components and their contents are as follows:

[0051]

[0052]

[0053] The preparation method of this liquid pharmaceutical composition is as follows:

[0054] Get enalapril maleate crude drug 1000g, add 7.56g silicon dioxide, mix evenly, pack into 10000 parts. When using, use one part of diluent to dissolve one part of solid powder, first take part of the diluent and add it to the solid powder, shake to fully dissolve the solid powder, then add the remaining diluent, shake and mix evenly.

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing enalapril and a preparation method thereof. The solid pharmaceutical composition is composed of enalapril/pharmaceutically-acceptable salts of enalapril and silica. A liquid diluent is added into the solid pharmaceutical composition before application; then the mixture is shaken to evenly mix the composition and the diluent; and thus the solid pharmaceutical composition is converted into a liquid pharmaceutical composition; wherein the liquid diluent is selected from but not limited to the following components: water, syrup, fruit juice, beverage, suspension, emulsion, or composition thereof. The provided solid pharmaceutical composition containing enalapril has a good stability and long shelf life, at the same time the fluidity problem of materials is well solved, and the solid pharmaceutical composition is suitable for the mechanical massive production. Moreover, the reconstructed liquid pharmaceutical composition prepared from the solid pharmaceutical composition also has a good stability and long shelf life, and thus the risk during the storage process of preparation is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing enalapril and a preparation method thereof. Background technique [0002] With the development of society and the improvement of people's living standards, hypertension has become one of the main diseases causing serious health problems in many countries. According to statistics, about one-third of adults in the United States suffer from high blood pressure, and there is an increasing trend year by year. According to incomplete statistics from the World Health Organization, the incidence of cardiovascular disease (CVD) in my country is 1.78% for men and 1.10% for women, and the prevalence rate increases with age. There are about 230 million CVD patients in the country, and every 100 adults 20 people suffer from CVD, and the number of deaths due to it is about 3.5 million in the country every year, and 9,590 people die fr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K47/04A61P9/12
Inventor 刘锋郑阳
Owner AC PHARMA CO LTD
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