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Montelukast sodium chewing tablet prescription and preparation process thereof

A technology of montelukast sodium and chewable tablets, which is applied in the field of symptomatic drugs, montelukast sodium chewable tablet formulations, which can solve the problems of difficulty in adapting to children, long drug residence time, and slow melting speed in the mouth. Good fluidity and compressibility, shortened production process cycle, and improved patient compliance

Active Publication Date: 2014-01-08
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] There is a problem with the existing chewable tablets of montelukast sodium that has not been well solved, that is, the melting speed in the mouth is slow, which causes the drug to stay in the mouth for a long time, and the taste of the drug is difficult to remove, and some children are difficult to adapt to it.

Method used

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  • Montelukast sodium chewing tablet prescription and preparation process thereof
  • Montelukast sodium chewing tablet prescription and preparation process thereof
  • Montelukast sodium chewing tablet prescription and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051]

[0052]

[0053] Preparation:

[0054] 1) Montelukast sodium API, microcrystalline cellulose, polylactic acid, mannitol, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, red iron oxide, aspartame Pass through 80 mesh sieve respectively.

[0055] 2) Take montelukast sodium, microcrystalline cellulose, polylactic acid, mannitol, 3 g of croscarmellose sodium, hydroxypropyl cellulose, red iron oxide, and aspartame in equal increments After being put into a three-dimensional motion mixer and mixed for 50 minutes, magnesium stearate was added and mixed for 5 minutes. The mixed material is put into the hopper of a high-speed rotary tablet press, and the tablet is pressed with an appropriate tablet weight and pressure.

Embodiment 2

[0057]

[0058] 1) Montelukast sodium API, microcrystalline cellulose, polylactic acid, mannitol, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, red iron oxide, aspartame Pass through 80 mesh sieve respectively.

[0059] 2) Take montelukast sodium, microcrystalline cellulose, polylactic acid, mannitol, 4.8 g of croscarmellose sodium, hydroxypropyl cellulose, red iron oxide, and aspartame in equal increments Method Put it into a three-dimensional motion mixer and mix for 50 minutes, then add magnesium stearate and mix for 5 minutes. The mixed material is put into the hopper of a high-speed rotary tablet press, and the tablet is pressed with an appropriate tablet weight and pressure.

Embodiment 3

[0061]

[0062] Preparation:

[0063] 1) Montelukast sodium API, microcrystalline cellulose, polylactic acid, mannitol, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, red iron oxide, aspartame Pass through 80 mesh sieve respectively.

[0064] 2) Take montelukast sodium, microcrystalline cellulose, polylactic acid, mannitol, croscarmellose sodium, hydroxypropyl cellulose, red iron oxide, and aspartame in equal increments, After being put into a three-dimensional motion mixer and mixed for 50 minutes, magnesium stearate was added and mixed for 5 minutes. The mixed material is put into the hopper of a high-speed rotary tablet press, and the tablet is pressed with an appropriate tablet weight and pressure.

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PUM

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Abstract

The invention relates to montelukast sodium chewing tablets and a preparation process thereof. The tablets comprise montelukast sodium and a filling agent, a diluting agent, a bonding agent, a disintegrating agent, and a flavoring. The tablets are prepared with a powder direct tabletting method. The fluidity and compressibility are good. The chewing tablets have long-term storage stability. The tablets are used in prevention and long-term treatment of asthma of children aged 2 to 14, and are used in relieving symptoms caused by allergic rhinitis.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a preventive and long-term treatment suitable for children aged 2 to 14, including preventing daytime and nighttime asthma symptoms, treating asthmatics sensitive to aspirin, and preventing exercise-induced bronchoconstriction. Medicines to relieve symptoms caused by allergic rhinitis. In particular, it relates to a chewable tablet form of montelukast sodium. Background technique [0002] According to epidemiological investigation and analysis, the incidence of respiratory diseases accounts for 16% of the total population prevalence, and about 280 million people worldwide suffer from seasonal asthma of varying degrees. In industrially developed countries and countries with high tobacco consumption The area is more serious, 5% of adults and 20% of children have been affected by this disease, and many people have bronchial asthma induced by long-term coughing ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/34A61P11/02A61P11/06A61P37/08
Inventor 袁淑杰孙照英王晓颖杨新春王丽娜张道旭王忠李郑武高晶宋紫玉
Owner 哈药集团股份有限公司
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