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Montelukast sodium tablet

A technology of montelukast sodium tablets and montelukast sodium, which is applied in the field of medicine, can solve problems such as instability to light, achieve the effects of reducing surface area, improving stability, and preventing photodegradation

Active Publication Date: 2016-04-06
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In the prior art, in order to ensure the stability of the drug to light, only opacifiers are added and the packaging is protected from light, which does not completely solve the problem of light instability in the production process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030]

[0031] Preparation Process:

[0032] Prescription amount weighed microcrystalline cellulose, menthol and montelukast acid, mixed evenly, added an appropriate amount of 50% ethanol solution, granulated, extruded and spheronized to prepare pellets, added to methanol solution containing sodium hydroxide, Stir, filter, and dry at 40°C to obtain microcrystalline cellulose pellets containing montelukast sodium. Then it is mixed with sodium carboxymethyl starch and lactose magnesium stearate, and compressed into tablets.

Embodiment 2

[0034] prescription:

[0035]

[0036] Preparation Process:

[0037] Prescription quantity Weigh microcrystalline cellulose, menthol and montelukast acid, mix them evenly, add an appropriate amount of 60% ethanol solution, granulate, extrude and spheronize to prepare small pellets, add them to methanol solution containing sodium hydroxide, Stir, filter, and dry at 45°C to obtain microcrystalline cellulose pellets containing montelukast sodium. It is then mixed with crospovidone, lactose, and magnesium stearate, and compressed into tablets.

Embodiment 3

[0039] prescription:

[0040]

[0041] Preparation Process:

[0042] Prescription quantity Weigh microcrystalline cellulose, menthol and montelukast acid, mix them evenly, add an appropriate amount of 60% ethanol solution, granulate, extrude and spheronize to prepare small pellets, add them to methanol solution containing sodium hydroxide, Stir, filter, and dry at 45°C to obtain microcrystalline cellulose pellets containing montelukast sodium. Then it is mixed with crospovidone, microcrystalline cellulose and magnesium stearate, and compressed into tablets.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and provides a high-stability Montelukast sodium tablet. The Montelukast sodium tablet is prepared from microcrystalline cellulose, menthol, microcrystalline cellulose pellets and an auxiliary material acceptable pharmaceutically, wherein the microcrystalline cellulose pellets are prepared from Montelukast sodium. Compared with the prior art, the Montelukast sodium tablet has the following advantages that medicine is encapsulated in microcrystalline cellulose cavities, and therefore stability is greatly improved; the preparation process is simple and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a montelukast sodium tablet. Background technique [0002] 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 world. . In 1998, the Montelukast sodium film-coated tablets of Merck & Co., Ltd. were approved by the US FDA for marketing. So far, the dosage forms of Montelukast sodium that have been on the market include granules, chewable tablets, and orally disintegrating tablets. Montelukast sodium, its chemical name is [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinoline)vinyl]phenyl-3-[ Sodium 2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetate. The chemical structure is: [0003] [0004] The isomer conversion process of montelukast sodium is as follows: ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/38A61P11/06
CPCA61K9/2027A61K9/2054A61K9/2059A61K31/47
Inventor 张贵民郝贵周任英
Owner LUNAN BETTER PHARMA
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