复方盐酸二甲双胍肠溶缓释微丸的制备  

Preparation of Compound Metformin Hydrochloride Enteric-coated and Sustained-release Pellets

作　　者：宦立娟 郑春丽[1] 樊丽雅 刘建平[1] 朱家壁[1] 

机构地区：[1]中国药科大学药物制剂研究所,南京210009 [2]内蒙古科技大学包头医学院药学院,包头014060

出　　处：《药学与临床研究》2015年第2期119-122,共4页Pharmaceutical and Clinical Research

基　　金：江苏省普通高校研究生科研创新计划项目(CXZZ13_0327)

摘　　要：目的:制备复方盐酸二甲双胍肠溶缓释微丸,并考察制剂体外释放特性。方法:利用底喷式流化床包衣设备,以空白丸芯、羟丙基甲基纤维素、单硬脂酸甘油酯、Eudragit NE30D、EudragitL100-55等制备盐酸二甲双胍肠溶缓释微丸;羟丙基甲基纤维素等制备盐酸吡格列酮胃溶微丸。结果:制备的盐酸二甲双胍肠溶缓释微丸在肠液中缓慢释放12 h,盐酸吡格列酮胃溶微丸在人工胃液中30 min溶出85%以上。结论:优选出的复方盐酸二甲双胍肠溶缓释微丸的制备工艺简单易行,重现性好,有望应用于工业化生产。Objective: To develop the compound metformin hydrochloride enteric-coated and sustainedrelease pellets and also to study its in vitro drug release. Methods: The fluid-bed coating equipment was used to prepare pellets. The metformin hydrochloride enteric-coated and sustained-release pellets were prepared with Eudragit NE30 D, Eudragit L100-55, HPMC-E5 and glycerylmonostearate(GMS). HPMC-E5 was used to prepare pioglitazone hydrochloride pellets. Results: The prepared metformin hydrochloride entericcoated and sustained-release pellets in vitro slowly released for 12 hours. The pioglitazone hydrochloride pellets dissolved more than 85% in the artificial gastric juice in 30 minutes. Conclusions: We prepared the preferred preparation of compound metformin hydrochloride enteric-coated and sustained-release pellets.The preparing process is simple and reproducible. It can be used in industrial production.

关 键 词：盐酸二甲双胍 肠溶缓释微丸 盐酸吡格列酮 累积释放度 流化床包衣 

分 类 号：R944.9[医药卫生—药剂学] TQ460.6[医药卫生—药学]