摘要
目的优化塞来昔布胶囊的处方工艺,并做稳定性考察试验。方法通过与原研品(西乐葆)溶出行为比较优化处方工艺;以有关物质、含量和溶出度为指标,通过加速试验和长期试验并与参比制剂进行对比试验考察胶囊剂的质量。结果确定的处方采用D90为10μm的原料,1%交联羧甲基纤维素钠,2%十二烷基硫酸钠;放大生产的三批样品的加速、长期试验样品合格且结果稳定。结论优化处方与原研品溶出行为一致,自制的胶囊剂质量稳定可控。
Objective To optimize the prescription process of celecoxib capsules, and inspected the stability. Methods By comparing the dissolution behavior of the self-made celecoxib capsules and reference product（Celebrex） optimize the prescription process. By the related substances, content and dissolution of celecoxib capsules inspected quality of capsule. Results The optimal preparation contained raw materials（D90≦10μm）, 1% carboxymethyl cellulose sodium, and 2% SDS. The test results of accelerated long-term test were qualified and stable. Conclusion The results showed that dissolution behavior of optimizated prescription were similar with that of Celebrex. And the self-made capsule is stable and controllable in quality.
出处
《中国卫生产业》
2016年第4期168-171,共4页
China Health Industry
关键词
塞来昔布
处方筛选
溶出曲线
相似因子f2
稳定性
Celecoxib
Selected formulation
Dissolution curve
Similarity factor
stability
