挤出滚圆法制备埃索美拉唑镁肠溶微丸  

Preparation of esomeprazole magnesium enteric-coated pellets by extrusion spheronization

作　　者：罗军波[1,2] 余洛汀[1] 郑强[2] 柯潇[2] 

机构地区：[1]四川大学生物治疗国家重点实验室,成都610041 [2]成都康弘药业集团股份有限公司,成都610036

出　　处：《中南药学》2013年第10期735-738,共4页Central South Pharmacy

摘　　要：目的研制埃索美拉唑镁肠溶微丸并对其产品质量进行评价。方法用挤出滚圆工艺和流化床包衣法制备埃索美拉唑镁肠溶微丸,并对产品质量进行评价来进行处方和工艺的优化。结果所制得的微丸制剂在人工胃液中耐酸力良好,在人工肠液中的释放迅速且完全。结论有效解决了埃索美拉唑镁的稳定性问题,而且制备工艺简单可行,重现性良好,有望进行工业化生产。Objective To prepare esomeprazole magnesium enteric-coated pellets and evaluate the quality of the product. Methods Esomeprazole magnesium enteric-coated pellets were prepared by extrusion spheronization process and fluidized bed coating, and the quality of products for formula and process optimization were evaluated. Results The pellets obtained in artificial gastric acid formulation had good acid strength, the dissolution in artificial intestinal fluid was rapid and complete. Conclusion The method was effective to solve the stability problem of esomeprazole magnesium.

关 键 词：埃索美拉唑镁 肠溶微丸 挤出滚圆法 流化床包衣 

分 类 号：R944[医药卫生—药剂学]