奥利司他微丸胶囊的制备

Preparation of capsules filled with orlistat pellets

目的采用挤出滚圆法制备奥利司他微丸,研究处方及制备工艺。方法采用单因素实验优化制剂处方,评价微丸的粉体学性质及收率。对影响微丸成型的关键工艺参数进行正交设计筛选优化。采用f B2B相似因子法考察自制胶囊与原研胶囊在不同溶出介质溶出相似性。结果用挤出滚圆法制备的奥利司他微丸圆整度好、粒度分布窄、收率高,与原研胶囊在4种溶出介质中的相似因子均大于50。结论成功地制备了奥利司他微丸,该制备工艺重现性好、质量高,制备的微丸胶囊与原研胶囊体外溶出行为相似。

Objective To prepare orlistat pellets by extrusion-spheronization and study the influence of formulation and process parameters on the properties of the pellets. Methods Using single factor test,formulation of the pellets were optimized. Effects of the key parameters on the properties of the pellets were investigated using orthogonal design. The dissolution behaviors of self-prepared preparation were compared with that of reference preparation in different dissolution media,and the similarity was evaluated using f B 2 B factor method.Results The orlistat pellets presented perfect sphericity,high yield,and sharp size distribution as well. The similarity factors compared with reference preparation were all more than 50. Conclusion The orlistat pellets were successfully prepared by extrusion-spheronization with good reproducibility and high-quality,and the dissolution behavior was similar with that of the reference preparation in different dissolution media.