脱卷积法研究盐酸二甲双胍缓释片的体内外相关性

Evaluation of in vitro-in vivo correlation for metformin hydrochlo- ride sustained-release tablets by deconvolution method

目的研究盐酸二甲双胍缓释片体内外相关性。方法应用释放度测定法研究盐酸二甲双胍缓释片的体外释药行为;用HPLC法测定盐酸二甲双胍缓释片在人体内的血药浓度;采用脱卷积法计算体内释放特性,与相应的体外释药特性进行比较。结果盐酸二甲双胍缓释片体外释放百分率和体内吸收百分率的相关性良好(r=0.910 3)。结论脱卷积法适用于盐酸二甲双胍缓释片的体内外相关性研究。

Objective To evaluate the in vitro-in vivo correlation for metformin hydrochloride sustained-release tablets by deconvolution method. Methods The in vitro drug release tests were used to evaluate the in vitro behavior of the sustained-release tablets. HPLC was applied for determining the concentration of metformin hydrochloride in human plasma. The correlation was studied between the in vitro release test and the in vivo absorption by deconvolution method. Results There was a fine correlation between the absorption in vivo and the release in vitro of metformin hydrochloride sustained-release tablets. Conclusions The deconvolution method exhibits advantage in evaluation of in vitro-in vivo correlation for metformin hydrochloride sustained-release tablets.