艾司奥美拉唑镁肠溶多颗粒释药胶囊的研究  

Preparation of Esomeprazole Magnesium Enteric-Coated Capsules

作　　者：罗军波[1] 徐雄良[1] 秦应飞 郑强[1] 柯潇[1] 

机构地区：[1]成都康弘药业集团股份有限公司,成都610036

出　　处：《中国药学杂志》2015年第9期789-792,共4页Chinese Pharmaceutical Journal

基　　金：四川省科技支撑计划资助项目(2014SZ0120)

摘　　要：目的研究艾司奥美拉唑镁肠溶多颗粒释药胶囊的制备工艺,并对其工艺进行评价。方法采用流化床包衣法制备艾司奥美拉唑镁肠溶微丸,考察隔离层、丸芯用量、肠溶衣膜厚度等对工艺的影响。结果所制得的肠溶多颗粒释药胶囊在人工胃液中耐酸能力好,在人工肠液中释放迅速完全。结论制备的艾司奥美拉唑镁肠溶多颗粒释药胶囊工艺可行,重现性好,与原研制剂具有质量相似性,有望应用于工业化生产。OBJECTIVE To prepare and evaluate esomeprazole magnesium enteric-coated capsules which is compacted by multi- ple-unit pellet system （MUPS）. METHODS The esomeprazole magnesium enteric-coated pellets were prepared by fluid bed coating technology, and the effects of isolation layer, amont of core, and thickness of enteric-coated film on the quality of the product were e- valuated. RESULTS The prepared esomeprazole magnesium enteric-coated capsules showed good release behavior in artificial gastric fluid. The dissolution in artificial intestinal fluid was rapid and complete. CONCLUSION The established process of preparing es- omeprazole magnesium enteric-coated pellets is feasible and reproducible, and the product has similar quality with the original prepara- tion. It is expected to be used in the industrial production.

关 键 词：艾司奥美拉唑镁 肠溶微丸 多颗粒释药系统 流化床包衣 

分 类 号：R944[医药卫生—药剂学]