柴胡总皂苷胶囊的制备工艺考察

目的:优选出柴胡总皂苷胶囊剂的最佳处方工艺。方法:采用饱和水溶液法制备柴胡总皂苷-β-环糊精包合物,以包合率为评价指标,采用正交试验优选包合物的最佳制备条件;以体外溶出度为评价指标,采用单因素法考察各种辅料包括崩解剂和粘合剂的种类和用量、表面活性剂的用量;以颗粒外观和体外溶出度为评价指标,考察颗粒干燥温度。结果:优选出最佳包合工艺为柴胡总皂苷和β-环糊精的重量比为1:2,包合温度为55℃,包合时间为1.5 h;最佳处方中交联羧甲基纤维素钠为崩解剂,用量为处方量的10%;以3%聚乙烯吡咯烷酮乙醇溶液(70%乙醇)为粘合剂;表面活性剂的用量为处方量的1.5%;颗粒干燥温度为60℃。结论:本制剂处方合理,制备工艺简单。

Study on the Preparation Procedure of Saikosaponins Capsules

Objective： To optimize the preparation process of Saikosaponins capsules. Method： The Saikosaponins-β-CD was prepared by saturated water solution method. Inclusion rate as the index, the preparation process was optimized by orthogonal experiment design. Dissolution in vitro as the index, excipients including disintegrants, adhesiveand and surfactant were screened by single-factor experiment. Appearance and dissolution in vitro as the indices, the drying temperature for the granules was also studied. Result： The optimal preparation process of the Saikosaponins-β-CD was as follows：the amount ratio of Saikosaponins and β-CD was 1：2, the inclusion temperature was 55 ℃ and the stirring time was 1.5 h. The optimal formulation included 10% CCMC-Na,3% PVP and 1.5% SDS.. The drying temperature was 60 ℃. Conclusion ： The preparation technology of the capsules was simple and reasonable.