痹舒缓释胶囊制备工艺研究

Study on the technology in manufacturing Bishu sustained-release capsule.

目的研究痹舒缓释胶囊的成型工艺。方法以总皂苷体外累积释放百分率为评价指标,筛选出胶囊微丸的制备方法,并对药物释放动力学过程进行释药模型拟合。结果最佳工艺条件为用淀粉作辅料泛制小丸,包苏丽丝衣膜,小丸增重16%～18%,装囊,得痹舒缓释胶囊。在1、4、8、10h,痹舒缓释胶囊总皂苷(UV法)体外累积释放百分率分别为10～30%、40～70%、70～90%、80～100%,经释药模型拟合,释放度与时间均有较好的相关性。结论制订的成型工艺对研制的痹舒缓释胶囊达到缓释胶囊的要求。

Objective To explore the preparatory procedure in manufacturing bishu sustained- release capsule. Methods The method of preparation of micro - pellets was optimized using the accumulation dissolution percentage of the total saponin as evaluation index and the drug delivery model was fitted. Results Micro- pellets idled in empty capsule was prepared by rolling technology using amylum as supplementary materials, then coated with surelease and the weight of the pellets was increased by 16 - 18%. The accumulation dissolution percentage of the total saponin from the sustained- release capsule determined with UV in vitro at lh, 4h, 8h and 10h were 10% - 30% ,40% - 70% ,70% - 90% and 80% - 100%, respectively. Conclusion Bishu sustained- release capsule produced with this technology meet the sustained- release requirement.