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目的:为优化芬布芬胶囊的最佳处方工艺参数进行研究。方法:通过正交试验优选出芬布芬胶囊的最佳工艺,优选出芬布芬胶囊的最佳处方组成为主药粒度205￣155μm,每万片含主药含主药1.5Kg、预胶化淀粉0.12Kg、硬脂酸镁0.01Kg、十二烷基硫酸钠0.008Kg、4%HPMC浆0.5Kg。结果:按照正交试验筛选出的最佳工艺进行生产三批胶囊,经检测及初步稳定性考察,质量符合2010版药典规定。结论:优化出芬布芬胶囊的溶出度在92%以上,且初步稳定性考察质量稳定。
Objective: To study the optimal formulation parameters of fenbufen capsule. Methods: The optimum process of fenbufen capsule was optimized by orthogonal test. The best prescription of fenbufen capsule was composed of main drug particle size 205 ~ 155μm, 0.12 kg of starch, 0.01 kg of magnesium stearate, 0.008 kg of sodium lauryl sulfate and 0.5 kg of 4% HPMC pulp. Results: Three batches of capsules were screened out according to the orthogonal test. The quality and stability of the three batches of capsules were tested according to the Pharmacopoeia 2010. Conclusion: The dissolution rate of fenbufen capsule is above 92%, and the quality of initial stability study is stable.