挤出滚圆和缓释包衣法制备止痛缓释微丸的研究

Preparation of sustained-release TCM pain pellets by extrusion-spheronization and coating technology

目的:优选中药止痛缓释微丸的制备工艺条件。方法:采用挤出滚圆工艺制备微丸,Surelease缓释包衣技术制备缓释微丸,采用析因设计对缓释包衣工艺参数进行了筛选。结果:确定了制剂处方及最佳工艺参数,润湿剂与物料的比例为0.55∶1,物料细度为100目,包衣增重4%,致孔剂用量为15%。结论:该工艺合理可行。

Objective： To optimize the procedures for preparing sustained-release traditional chinese medicine （TCM） pain pellets. Methods： The sustained-release TCM pain pellets were prepared by extrusion-spheronization and Surelease coating technologies. The critical process parameters for encapsulation of the pellets were optimized using fractional factorial design method. Results： The optimal parameters for preparing sustained-release TCM pain pellets were obtained. The best ratio of wetting agents and medicine material was 0.55： 1, the size of the medicine material was 100 mesh, the coating materials increased the total weight by 4% , and the pore making material was 15% of weight. Conclusion： The procedures for preparing sustained-release TCM pain pellets are reasonable and feasible.