Pharmaceutical composition containing montelukast sodium

A technology of montelukast sodium and composition, applied in the field of medicine, can solve the problems of easy discoloration and decomposition when exposed to light, poor formulation stability, no improvement in tablet stability, etc., and achieves simple and easy production operation and good stability. Effect

Active Publication Date: 2015-08-19
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent CN101732268A discloses a preparation method of montelukast sodium tablets, which adopts dry granulation and direct tablet compression, avoiding some effects caused by wet granulation, but dry granulation is more complicated and requires relatively high equipment. Moreover, the stability of the prepared tablet has not been improved, and it is also easy to change color and decompose when exposed to light.
[0005] Chinese patent CN1961867A discloses a granule of montelukast sodium, Chinese patent CN1287792C discloses a dispersible tablet of montelukast sodium, and Chinese patent CN101773481A discloses a chewable tablet containing montelukast sodium. The preparations are all made by general technology, and the prepared preparations are also poor in stability, and they are easy to change color and decompose when exposed to light.

Method used

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  • Pharmaceutical composition containing montelukast sodium
  • Pharmaceutical composition containing montelukast sodium
  • Pharmaceutical composition containing montelukast sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] prescription

[0064]

[0065] Preparation

[0066] (1) Mix and pulverize sucrose fatty acid ester and L-ascorbic acid through 80 mesh to obtain mixed powder;

[0067] (2) Spray the absolute ethanol solution of montelukast sodium onto the starch;

[0068] (3) Granulating the mixed powder obtained in steps (1) and (2) with dry starch and carboxymethyl cellulose;

[0069] (4) Mix the granules obtained in step (3) with micropowder silica gel, pack separately, and obtain.

Embodiment 2

[0071] prescription

[0072]

[0073] Preparation

[0074] (1) Mix and pulverize sucrose fatty acid ester and L-ascorbic acid through 80 mesh to obtain mixed powder;

[0075] (2) Spray the ethanol solution of montelukast sodium onto the lactose;

[0076] (3) Granulating the mixed powder obtained in steps (1) and (2) with sodium carboxymethyl starch and carboxymethyl cellulose;

[0077] (4) Mix the granules obtained in step (3) with talcum powder, pack separately, and obtain.

Embodiment 3

[0079] prescription

[0080]

[0081] Preparation

[0082] (1) Mix and pulverize sucrose fatty acid ester and L-ascorbic acid through 80 mesh to obtain mixed powder;

[0083] (2) Spray the absolute ethanol solution of montelukast sodium on the powdered sugar;

[0084] (3) Granulating the mixed powder obtained in steps (1) and (2) with low-substituted hydroxypropyl cellulose and carboxymethyl cellulose;

[0085] (4) Mix the granules obtained in step (3) with micropowder silica gel, pack separately, and obtain.

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PUM

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Abstract

The invention belongs to the technical filed of a medicine, and particularly relates to a pharmaceutical composition containing montelukast sodium. The pharmaceutical composition contains montelukast sodium, sucrose fatty acid ester, and L-ascorbic acid. The pharmaceutical composition is good in stability and has excellent quality. The production operation of the pharmaceutical composition is simple and easy, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition containing montelukast sodium and a preparation method of granules thereof. Background technique [0002] The structure of montelukast sodium is (+)-1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)-vinyl]phenyl] -3-[2-(1-Hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid monosodium salt. Montelukast sodium is a white to off-white powder, soluble in methanol, ethanol and water, but insoluble in acetonitrile. [0003] The terminal carbon atom of montelukast sodium molecule contains a hydroxyl group, two methyl groups and a benzene ring, and the steric hindrance is very large. During the storage process of montelukast sodium, under the catalysis of temperature, the related substances will gradually Increase. [0004] Chinese patent CN101732268A discloses a preparation method of montelukast sodium tablets, which adopts ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/47A61K47/26A61K47/22
Inventor 张春苗徐璐王小雪
Owner 长春海悦药业股份有限公司
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