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Solid oral preparation containing montelukast and preparation method of solid oral preparation

A technology of montelukast sodium and oral preparations, which is applied in the field of solid oral preparations containing montelukast sodium and its preparation, and can solve the problem of poor wet stability and the inability to fundamentally solve the stability of montelukast sodium, Sensitivity and other issues, to achieve the effect of improving stability, using less excipients, and simple preparation process

Inactive Publication Date: 2015-06-03
曲素欣
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As for the problem of sensitivity to light, the existing technology is to add sunscreen to solve the problem of sensitivity to light; for the problem of poor moisture stability, the solution of the prior art is to pack moisture-proof clothing or more stringent packaging conditions and packaging form
However, no matter what kind of auxiliary material is added in the tablet, it can only improve its stability to a certain extent, and cannot fundamentally solve the stability problem of montelukast sodium

Method used

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  • Solid oral preparation containing montelukast and preparation method of solid oral preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Montelukast Sodium 10g

[0029] 100g pregelatinized starch

[0030] Sucrose Fatty Acid Ester 4g

[0031] Preparation Process:

[0032] Grind montelukast sodium through an 80-mesh sieve, and set aside; dry the pregelatinized starch at 105°C, airtightly let it cool, and set aside; weigh the amount of montelukast sodium, pregelatinized starch, and sucrose fatty acid ester and mix evenly , Φ6.5mm shallow arc stamping sheet, that is. After testing, the initial moisture content of the tablet was 0.91%.

Embodiment 2

[0034] Montelukast Sodium 10g

[0035] 200g pregelatinized starch

[0036] Sucrose Fatty Acid Ester 11g

[0037] Preparation Process:

[0038]Grind montelukast sodium through an 80-mesh sieve, and set aside; dry the pregelatinized starch at 105°C, airtightly let it cool, and set aside; weigh the amount of montelukast sodium, pregelatinized starch, and sucrose fatty acid ester and mix evenly , Φ9mm shallow arc stamping sheet, that is. After testing, the initial moisture content of the tablet was 0.42%.

Embodiment 3

[0040] Montelukast Sodium 10g

[0041] 300g pregelatinized starch

[0042] Sucrose Fatty Acid Ester 20g

[0043] Preparation Process:

[0044] Grind montelukast sodium through an 80-mesh sieve, and set aside; dry the pregelatinized starch at 105°C, airtightly let it cool, and set aside; weigh the amount of montelukast sodium, pregelatinized starch, and sucrose fatty acid ester and mix evenly , Φ10mm shallow arc stamping sheet, that is. After testing, the initial moisture content of the tablet was 0.59%.

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Abstract

The invention discloses a solid oral preparation containing montelukast and a preparation method of the solid oral preparation. The preparation comprises the following steps: crushing and screening montelukast; mixing the crushed and screened montelukast with dried pregelatinized starch and sucrose fatty acid ester evenly; and tabletting. Compared with the prior art, the solid oral preparation has the advantages of low auxiliary material amount and simple preparation technology; and meanwhile, the stability of the montelukast tablet is relatively well improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid preparation of western medicine, in particular to a solid oral preparation containing montelukast sodium and a preparation method thereof. Background technique [0002] Montelukast Sodium is a white or off-white powder with hygroscopic properties, easily soluble in ethanol, methanol, and water, and almost insoluble in acetonitrile. Its chemical name is [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinoline) vinyl]phenyl-3-[2-(1-hydroxy -1-Methylethyl)phenyl]propyl]sulfur]methyl]cyclopropane sodium acetate, molecular formula C 35 h 35 CINNaO 3 S, molecular weight 608.1, structural formula: [0003] [0004] Montelukast sodium is the sodium salt of Montelukast. Due to its unique chemical structure, its oral bioavailability, clinical efficacy and safety are superior to previous similar drugs, and it is currently the best-selling asthma drug in the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/404A61K47/26A61K47/36A61P11/06
Inventor 王菊明
Owner 曲素欣
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