Preparation and <i>in Vitro</i>Drug Release Evaluation of Once-Daily Metformin Hydrochloride Sustained-Release Tablets

The objective of this study was to develop once-daily metformin hydrochloride sustained-release tablets (MHSRT) and evaluate their in vitro release behavior. MHSRT were prepared by the film coating method. The in vitro drug release rate of MHSRT and the commercial tablets Fortamet? made in the United States of America in water was fitted with zero order kinetic equation, and Ritger-Peppas kinetic equation in 0.1 M HCl and pH 6.8-phosphate buffer, respectively. The similarity factor f2 values of MHSRT in three different dissolution medium were 82, 80 and 74, respectively in comparison with imported Fortamet?, which were all greater than 50. The results of storage-stability showed that MHSRT were stable for at least 6 months under stress condition (40℃ ± 2℃, RH 75% ± 5%). Therefore, in this study, MHSRT were successfully prepared using optimized formulation technologies that meet mass produce. The in vitro release behavior of MHSRT was almost similar to that of imported Fortamet?.

光纤传感技术实时在线监测盐酸二甲双胍缓释片体外溶出过程的研究

目的采用光纤药物溶出度实时测定仪考察不同厂家盐酸二甲双胍缓释片体外溶出度曲线。方法按照国家食品药品监督管理局标准YBH31132005规定的溶出度方法进行实时溶出曲线测定。结果本法监测药物溶出的全过程,显示药物实时溶出曲线图,可直接提取相关参数。结论光纤化学传感检测过程中不需要取样、过滤、补液等操作,简便易行,极大地节省了劳动强度,提高了测定的精密度和准确度,获得的数据信息完整,反映了药物在体外溶出的过程,替代了繁琐的传统测试方法。光纤化学溶出度过程监测法能够有效地监测固体制剂的体外溶出度,并能真实地反映药物溶出的全过程。