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Montelukast tablet composition and preparation method thereof

A technology of montelukast sodium and its composition, which is applied in the field of montelukast sodium tablet composition and its preparation, can solve the problems of increasing the possibility of decomposition and the increase of substances, so as to achieve easy control of the production process and the prevention of related substances Low content, good practical effect

Inactive Publication Date: 2013-04-17
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The traditional montelukast sodium tablet composition and its preparation method are raw and auxiliary materials wet granulated and then compressed into tablets. The raw and auxiliary materials are affected by the humid and hot environment and light before compression, which increases the possibility of decomposition and increases the number of related substances.

Method used

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  • Montelukast tablet composition and preparation method thereof
  • Montelukast tablet composition and preparation method thereof
  • Montelukast tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A Montelukast sodium tablet composition, comprising the following components in parts by weight:

[0044]

[0045]

[0046] A preparation method of montelukast sodium tablet composition, comprising the following steps:

[0047] (1) Montelukast sodium, Microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose passed through a 60-mesh sieve, magnesium stearate passed through a 100-mesh sieve, and mixed uniformly;

[0048] (2) Weigh the prescribed amount of montelukast sodium, Microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate were dropped into a mixer and mixed for 25 minutes, and set aside;

[0049] (3) Powder compression;

[0050] (4) Configure coating solution: mix Opadry The film coating premix was added into purified water while stirring, and then stirred for 45 minutes to prepare a coating solution with a concentration of 18%, passed through an 80-mesh sieve, and set aside;

[0051] (5) Fi...

Embodiment 2

[0053] A Montelukast sodium tablet composition, comprising the following components in parts by weight:

[0054]

[0055] A preparation method of montelukast sodium tablet composition, comprising the following steps:

[0056] (1) Preparation of porous sorbitol: After the water-soluble sorbitol is dissolved, it is prepared into porous particles by spray-drying;

[0057] (2) Pass montelukast sodium, porous sorbitol, croscarmellose sodium, low-substituted hydroxypropyl cellulose through a 60-mesh sieve, and magnesium stearate through a 100-mesh sieve, and mix well;

[0058](3) Weigh the prescribed amount of montelukast sodium, porous sorbitol, croscarmellose sodium, low-substituted hydroxypropyl cellulose and magnesium stearate, put them into a mixer and mix for 45 minutes, and set aside;

[0059] (4) Powder compression;

[0060] (5) Configure coating solution: mix Opadry The film coating premix was added into purified water while stirring, and then stirred for 45 minutes ...

Embodiment 3

[0063] A Montelukast sodium tablet composition, comprising the following components in parts by weight:

[0064]

[0065] A preparation method of montelukast sodium tablet composition, comprising the following steps:

[0066] (1) Montelukast sodium, Croscarmellose sodium, low-substituted hydroxypropyl cellulose are passed through a 60-mesh sieve, magnesium stearate is passed through a 100-mesh sieve, and mixed uniformly;

[0067] (2) Weigh the prescribed amount of montelukast sodium, Croscarmellose sodium, low-substituted hydroxypropyl cellulose and magnesium stearate were put into a mixer and mixed for 30 minutes, and set aside;

[0068] (3) Powder compression;

[0069] (4) Configure coating solution: mix Opadry The film coating premix was added into purified water while stirring, and then stirred for 30 minutes to prepare a coating solution with a concentration of 18%, passed through an 80-mesh sieve, and set aside;

[0070] (5) Film-coating to obtain the composit...

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Abstract

The invention discloses a Montelukast tablet composition. The composition comprises Montelukast, porous filling agent, disintegrating agent, lubricant, opadry film coating premixing agent and purified water; and the stability of the Montelukast can be remarkably improved. The invention further discloses a preparation method for the Montelukast tablet composition; the powder is adopted to directly compress tablets, so that the operation is convenient, the influence to the product quality from the drying process and the hot and humid condition is avoided, the content of related substances is low, and the stability is remarkably improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a montelukast sodium tablet composition and a preparation method thereof. Background technique [0002] Montelukast is a new generation of oral leukotriene receptor antagonist. It is a powerful oral preparation that can significantly improve asthma inflammatory indicators. Biochemical and pharmacological bioassays show that Montelukast has high selectivity , can competitively antagonize the combination of leukotriene D4 (LTD4) and Cys-LTl receptors, and has a good curative effect on asthma; a large number of clinical application data show that montelukast is generally well tolerated and has mild adverse reactions. Usually there is no need to terminate treatment, and the overall incidence of adverse reactions of this product is similar to that of placebo; montelukast sodium has become a brand product of anti-asthma drugs due to its high compliance, good curat...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/47A61P11/06
CPCA61K9/2054A61K9/2059A61K9/2095A61K9/2866A61K31/47A61P11/06
Inventor 罗炳锋蔡瑶瑶李家炎郭琦曾环想李娟
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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