挤出-滚圆和流化床包衣法制备盐酸二甲双胍肠溶微丸

Study on Preparation of Enteric-Coated Metformin Hydrochloride Pellets by Extrusion-Spheronization and Fluidized Bed Coating Technology

目的研制盐酸二甲双胍肠溶微丸。方法采用挤出-滚圆工艺和流化床包衣法制备,用正交试验设计优化处方,考察产品的体外释放度。结果制得的盐酸二甲双胍肠溶微丸圆整度高、收率高、体外释放度好。结论所用制备工艺简单易行,重现性好。

Objective To develop Enteric-Coated Metformin Hydrochloride Pellets.Methods Enteric-Coated Metformin Hydrochloride Pellets was prepared with extrusion-spheronization and fluidized bed coating technology.The formulation was optimized by orthogonal design.The in vitro release of the pellets was determined.Results Enteric-Coated Metformin Hydrochloride Pellets prepared by this method had per-fect sphericity and high yield with good release in vitro.Conclusion The method is simple,feasible and replicable.