CAJ | 학술논문

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。
목적：제비복방염산이갑쌍고장용완석미환，병고찰제제체외석방특성。방법：이용저분식류화상포의설비，이공백환심、간병기갑기섬유소、단경지산감유지、Eudragit NE30D、Eudragit?L100-55등제비염산이갑쌍고장용완석미환；간병기갑기섬유소등제비염산필격렬동위용미환。결과：제비적염산이갑쌍고장용완석미환재장액중완만석방12 h，염산필격렬동위용미환재인공위액중30 min용출85%이상。결론：우선출적복방염산이갑쌍고장용완석미환적제비공예간단역행，중현성호，유망응용우공업화생산。
Objective: To develop the compound metformin hydrochloride enteric-coated and sustained-release 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 pre-pared with Eudragit NE30D, Eudragit?L100-55, HPMC-E5 and glycerylmonostearate(GMS). HPMC-E5 was used to prepare pioglitazone hydrochloride pellets. Results: The prepared metformin hydrochloride enteric-coated 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.