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

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.