Montelukast sodium composition

A technology of montelukast sodium and its composition, which is applied in the field of pharmaceutical manufacturing, can solve problems such as no improvement, achieve considerable economic and social benefits, good repeatability, and reduce hidden dangers

Active Publication Date: 2012-07-11
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Controlling the content of montelukast ketone is an urgent problem for the safe use of montelukast sodium, and the existing disclosed technology of montelukast sodium has no suggestion to improve the above shortcomings

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prescription of Montelukast Sodium Granules:

[0023]

[0024] Preparation:

[0025] Mix and pulverize montelukast sodium and polyacrylic acid resin L100-55 through 80 mesh to obtain mixed powder of montelukast sodium polyacrylic acid resin L100-55; Pour alcohol and hypromellose into a wet granulator and mix for 5 minutes, add water to prepare a soft material, granulate with 14 mesh, dry at 60 degrees for 2 hours, granulate with 24 mesh, add the prescribed amount of magnesium stearate and mix for 10 minutes, use Composite film filling, the difference in filling volume is controlled within ±5%.

Embodiment 2

[0027] Montelukast sodium chewable tablet prescription:

[0028]

[0029] Preparation:

[0030] Mix and pulverize montelukast sodium and polyacrylic acid resin L100-55 through 80 meshes to obtain montelukast sodium polyacrylic acid resin L100-55 mixed powder; mix montelukast sodium polyacrylic resin L100-55 mixed powder, micro Pour crystalline cellulose, mannitol, and hypromellose into a wet granulator and mix for 5 minutes, add water to prepare a soft material, granulate at 24 mesh, dry at 60°C for 2 hours, granulate at 20 mesh, add the prescribed amount of magnesium stearate Mix for 10 minutes, compress into tablets, and pack separately.

Embodiment 3

[0032] Prescription of Montelukast Sodium Tablets:

[0033]

[0034] Preparation:

[0035] Mix and pulverize montelukast sodium and polyacrylic acid resin L100-55 through 80 meshes to obtain montelukast sodium polyacrylic acid resin L100-55 mixed powder; mix montelukast sodium polyacrylic resin L100-55 mixed powder, micro Pour crystalline cellulose, lactose, and hypromellose into a wet granulator and mix for 5 minutes, add water to prepare a soft material, granulate at 24 mesh, dry at 60 degrees for 2 hours, granulate at 20 mesh, add the prescribed amount of magnesium stearate Mix for 10 minutes, press into tablets, and pack separately.

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PUM

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Abstract

The invention discloses a montelukast sodium composition, which comprises montelukast sodium and polyacrylic resin L100-55. The weight of the montelukast sodium accounts for 50-95 percent of the total weight of the composition, and the weight of the polyacrylic resin L100-55 accounts for 5-50 percent of the total weight of the composition. By adopting the technical scheme, the stability of the montelukast sodium can be improved significantly, and the risk of the montelukast sodium oxidized into montelukast ketone can be reduced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical manufacturing, and in particular relates to a montelukast sodium composition, which can be used for the prevention and long-term treatment of adult and child asthma and allergic rhinitis asthma syndrome. Background technique [0002] Asthma (bronchial asthma) is a chronic airway inflammation involving a variety of cells, especially mast cells, eosinophils, and T lymphocytes. In susceptible individuals, this inflammation can cause recurrent wheezing, shortness of breath, chest tightness, and (or) Cough and other symptoms mostly occur at night and (or) in the early morning, and the airway is more responsive to various stimuli. But the symptoms can be relieved by themselves or by treatment. Asthma is currently one of the most common chronic diseases in the world. It is estimated that 1 in every 20 people in the world suffers from asthma, accounting for about 300 million people. It is estimated that th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K31/47A61P11/06A61P11/02A61P37/08
Inventor 徐卓业鲍晓芳马爱军郝建华
Owner NANJING ZENKOM PHARMA
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