Montelukast tablet and preparation method thereof

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...

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