A kind of montelukast sodium preparation and preparation method thereof

A technology of montelukast sodium and preparation, applied in the field of montelukast sodium preparation and preparation thereof, can solve the problems of unseen, restricted research and development, etc., and achieve the effects of low water content, avoiding decomposition and deterioration, and being difficult to grow and reproduce

Active Publication Date: 2021-04-06
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These have all limited those skilled in the art in the research and development of montelukast sodium lyophilized orally disintegrating tablets, so that there is no montelukast sodium lyophilized orally disintegrating tablet in the prior art

Method used

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  • A kind of montelukast sodium preparation and preparation method thereof
  • A kind of montelukast sodium preparation and preparation method thereof
  • A kind of montelukast sodium preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] prescription:

[0045]

[0046]

[0047] Preparation:

[0048] 1) Micronizing the montelukast sodium bulk drug to obtain micronized montelukast sodium with a particle size of 80 μm;

[0049] 2) Put the pregelatinized starch in cold purified water and stir well until it is completely dissolved into a solution to obtain a pregelatinized starch solution;

[0050] 3) Weigh mannitol and micronized montelukast sodium according to the prescription amount, mix the two, then add to the pregelatinized starch solution obtained in step 2), stir well until the mannitol dissolves, and the montelukast The sodium is uniformly dispersed; then cooled under vacuum, and aspartame is added at the same time to obtain a suspension;

[0051] 4) Put the suspension obtained in step 3) into blister holes in divided doses, put it into a vacuum freeze-drying box for freeze-drying, and finally seal the drug-filled blister to obtain montelukast sodium freeze-dried orally disintegrating tablet...

Embodiment 2

[0053] prescription:

[0054]

[0055] Preparation:

[0056] 1) Micronizing the montelukast sodium bulk drug to obtain micronized montelukast sodium with a particle size of 100 μm;

[0057] 2) Put the pregelatinized starch in cold purified water and stir well until it is completely dissolved into a solution to obtain a pregelatinized starch solution;

[0058] 3) Weigh mannitol and micronized montelukast sodium according to the prescription amount, mix the two, then add to the pregelatinized starch solution obtained in step 2), stir well until the mannitol dissolves, and the montelukast The sodium is uniformly dispersed; then cooled under vacuum, and aspartame is added at the same time to obtain a suspension;

[0059] 4) Put the suspension obtained in step 3) into blister holes in divided doses, put it into a vacuum freeze-drying oven, cool down to minus 45°C, keep it for 2 hours, vacuumize, then gradually raise the temperature to 0°C, keep it for 2 hours, and then Gradua...

Embodiment 3

[0061] prescription:

[0062]

[0063] Preparation:

[0064] 1) Micronizing the montelukast sodium bulk drug to obtain micronized montelukast sodium with a particle size of 120 μm;

[0065] 2) Put the pregelatinized starch in cold purified water and stir well until it is completely dissolved into a solution to obtain a pregelatinized starch solution;

[0066] 3) Weigh mannitol and micronized montelukast sodium according to the prescription amount, mix the two, then add to the pregelatinized starch solution obtained in step 2), stir well until the mannitol dissolves, and the montelukast The sodium is uniformly dispersed; then cooled under vacuum, and aspartame is added at the same time to obtain a suspension;

[0067] 4) Put the suspension obtained in step 3) into blister holes in divided doses, put it into a vacuum freeze-drying oven, cool down to minus 45°C, keep it for 2 hours, vacuumize, then gradually raise the temperature to 0°C, keep it for 4 hours, and then Gradua...

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a montelukast sodium preparation and a preparation method thereof. The described montelukast sodium preparation is a freeze-dried orally disintegrating tablet, and the freeze-dried orally disintegrating tablet (1000 tablets) includes the following raw material components: 5 g of montelukast sodium, 80-120 g of pregelatinized starch, manna Alcohol 150-200g, appropriate amount of aspartame and purified water 1200-1500ml. The freeze-dried orally disintegrating tablet of montelukast sodium of the present invention not only has good stability, but also disintegrates rapidly, and solves the problem of good physical strength and disintegration performance of the tablet prepared by the freeze-drying method and the problem of hygroscopicity.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a montelukast sodium preparation and a preparation method thereof. Background technique [0002] Asthma is a common respiratory disease, which is related to allergic constitution and genetic factors. Asthma is a type I hypersensitivity disease, and its pathogenesis is mainly due to the release of active mediators, such as leukotrienes, histamine and prostate, which cause bronchospasm and pulmonary ventilation disorders. Induces degranulation of mast cells and basophils. Asthma is a world-recognized medical problem, and is listed as one of the four major persistent diseases by the World Health Organization. According to the survey, there are at least 20 million asthmatics in my country, and the symptoms related to asthma mainly include cough, expectoration, wheezing, dyspnea, and chest tightness. The typical manifestation is paroxysmal expiratory dyspnea accompani...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/36A61K47/26A61K31/47A61P11/06
CPCA61K9/0056A61K9/2018A61K9/2059A61K9/2095A61K31/47A61P11/06
Inventor 王印刘登禹马鹰军刘丽媛
Owner HAINAN JINRUI PHARMA CO LTD
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