利福昔明胶囊处方的研制及质量控制

目的 优选利福昔明胶囊的最佳处方和制备工艺及其质量标准，．方法用正交试验法对利福昔明胶囊的辅料进行筛选，并对质量控制方法进行研究。结果选用30％的糖粉，2％羟丙基甲基纤维素，1．5％的十二烷基硫酸钠和0．5％的硬脂酸镁作为润滑剂，进行湿法制粒，分装胶袭。制备的利福昔明胶囊平均溶出度为100．4％，3批利福昔明胶囊含量分别为99．2%，99．8％，100．1％。结论利福昔明胶囊处方设计合理，工艺可行，质量稳定。所建立的分析方法可用于利福昔明胶囊含量的测定，且方法简便、准确。

Preparation and quality control Rifaximin Capsules

Objective To study the preparation and quality control of rifaximin Capsules. Methods The formulation of rifaximin Capsules was optimized by an orthogonal design. The quality control was evaluated. Results The optimal formulation of rif：aximin Capsules was consisted of 0.2g rifaximin, 30% powdered sugar, 2% HPMC, 1.5% sodium lauryl sulfate, 0.5% magnesium stearate as lubricant.The Particles were perpared by a wet granulation, packaged Capsule. P, ifaximin Capsules showed the average dissolution rate of 100.4% within 45rain. The contents of three batches of Rifaximin capsules were 99.2%, 99.8% and 100.1%respectively. Conclusion The rif;aximin Capsules formulation was stable and suitable for industral production. The assay method is rapid, simple and accurate.