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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。
Objective: To optimize the prescription of Bupleurum total saponin capsules. Methods: Bupleurum total saponin-β-cyclodextrin inclusion complex was prepared by saturated aqueous solution method. The inclusion rate was the evaluation index, and the optimum preparation conditions were optimized by orthogonal test. Dissolution in vitro was used as evaluation index The single factor method was used to investigate the types and amounts of various excipients including disintegrant and binder, and the amount of surfactant. The particle appearance and in vitro dissolution were used as evaluation indexes to examine the drying temperature of granules. Results: The optimum inclusion process was that the weight ratio of total saponins of Bupleurum and β-cyclodextrin was 1: 2, the inclusion temperature was 55 ℃ and the inclusion time was 1.5 h. The dosage of sodium Cellulose was 10% of the prescription, the dosage of 3% polyvinylpyrrolidone ethanol (70% ethanol) as binder, the dosage of surfactant was 1.5% of the prescription, the temperature of the granule drying 60 ° C. Conclusion: The preparation prescription is reasonable, the preparation process is simple.