Celecoxib-containing capsule

Abstract

The invention relates to a celecoxib-containing capsule, which contains 40wt%-70wt% of celecoxib, 22wt%-50wt% of a water-soluble filler, 0.5wt%-25wt% of low substituted hydroxypropyl cellulose, and 0.5wt%-10wt% of sodium dodecyl sulfate. The celecoxib capsule with a prescription provided by the invention has no special requirement for the particle size of celecoxib, the celecoxib bulk drug directly synthesized by a conventional synthesis method can be taken as a preparation raw material, and no special treatment is needed. The preparation process is simple, the product quality is uniform and stable, and has effective bioavailability.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a capsule containing celecoxib. Background technique [0002] Celecoxib (Celecoxib, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide) is produced by G.D. The developed coxib non-steroidal anti-inflammatory drugs (NSAIDs) are as effective as traditional NSAIDs in terms of analgesia, anti-inflammatory and antipyretic, but due to their highly selective and specific inhibition of COX-2 It only reduces the synthesis of inflammatory prostaglandins without affecting the synthesis of physiological prostaglandins, thus reducing gastrointestinal damage, and its digestive tract safety is better than that of traditional NSAIDs. [0003] Celecoxib was launched in the United States on December 31, 1998, and is now on the market in 72 countries (regions) including North America, South America, Asia, and Europe. On August 4, 2000, my country approved the import of cele...

AI Technical Summary

Problems solved by technology

[0010] One of the problems to be solved in the present invention is that the celecoxib bulk drug synthesized cannot be directly used in the preparation of the existing celecoxib capsules, and the directly synthesized particle diameter D 90 The celecoxib API with a size of 20 μm to 50 μm is micronized to D 90 Only when the dissolution rate is less than 18 μm can a preparation with a dissolution rate meet the requirements be obtained; however, the micronization process requires high equipment, consumes a lot of energy and costs, and at the same time, the celecoxib particles after micronization are easy to aggregate into agglomerates, which is easy to dissolve when filling capsules. Sticky punch occurs, unable to fill smoothly

At the same time, the prior art also has technical problems such as poor capsule quality uniformity and stability without micronization

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