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Montelukast tablet and preparation method thereof

A technology of montelukast sodium tablet and montelukast sodium, which is applied in the field of montelukast sodium tablet and its preparation, can solve the problems of complex process and high production cost, achieve simple operation process and improve stability , Improve the effect of content uniformity

Active Publication Date: 2018-05-08
SHANGHAI ANBISON LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, colorants are still used to improve product stability, and this dry granulation uses complex polymer copolymers as binders, which has high production costs and complicated processes

Method used

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  • Montelukast tablet and preparation method thereof
  • Montelukast tablet and preparation method thereof
  • Montelukast tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]

[0041] Preparation Process:

[0042] Dissolve the prescribed amount of montelukast sodium and β-cyclodextrin in ethanol solution (90%), dry under reduced pressure at 40°C to remove ethanol, crush through a 60-mesh sieve, add the prescribed amount of microcrystalline cellulose, Add mannitol, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate after passing through a 40-mesh sieve, mix in a hopper mixer for 15 minutes, and compress into tablets.

Embodiment 2

[0044]

[0045] Preparation Process:

[0046] Weigh the prescribed amount of montelukast sodium and β-cyclodextrin and dissolve them in ethanol solution (60%), dry under reduced pressure at 50°C to remove ethanol, crush through an 80-mesh sieve, add the prescribed amount of microcrystalline cellulose, Add mannitol, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate after passing through a 40-mesh sieve, mix in a hopper mixer for 15 minutes, and then compress into tablets.

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PUM

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Abstract

The invention relates to a Montelukast tablet. The Montelukast table consists of Montelukast, beta-cyclodextrin, an adhesive, a disintegrating agent, a filling agent and a lubricating agent. A Montelukast clathrate compound is prepared by using the characteristic that beta-cyclodextrin is special in hole structure and nontoxic in excellent performance and can be clathrate with various objects, sothat Montelukast is prevented from being influenced by the factors such as light and oxygen due to the clathrate compound of cyclodextrin to be protected, and the stability of the Montelukast tablet is improved. The Montelukast is dispersed into beta-cyclodextrin, and compared with a common direct hybrid tabletting technology, the risk that Montelukast particles are non-uniform in distribution inthe production process is reduced, and the content uniformity of the tablet can be obviously improved.

Description

technical field [0001] The invention relates to a montelukast sodium tablet and a preparation method thereof. Background technique [0002] Montelukast sodium emerged as Merck's third-generation fourth leukotriene receptor antagonist drug candidate. Its safety and effectiveness have been confirmed. In pediatric clinical studies, the chewable dosage form also showed good results in infants and young children without affecting the growth rate of infants and young children. They eventually called it "Montelukast" in honor of its birthplace, Montreal. Montelukast (trade name Singulair) was launched in February 1998 and was approved for adults and children aged 6 to 14. In June 2000, Singulair was further approved by the U.S. Food and Drug Administration for use in infants with asthma over 1 year old. [0003] As an oral leukotriene receptor antagonist, montelukast sodium can specifically inhibit the cysteinyl leukotriene (CysLT1) receptor in the airway, thereby improving airw...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/69A61K31/47A61P11/06
CPCA61K9/2054A61K31/47
Inventor 谭然然沙平雷继峰施钰文
Owner SHANGHAI ANBISON LAB
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