脱卷积法研究盐酸二甲双胍缓释片的体内外相关性
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殷莉莉，刘晓红，靳 玲，孙英华，杨亚军，何仲贵
(沈阳药科大学 药学院, 辽宁 沈阳 110016)
摘要：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。
关键词：药剂学；体内外相关性；脱卷积法；盐酸二甲双胍；血药浓度；释放度
中图分类号：R94 文献标识码：A
contents
Evaluation of in vitro-in vivo correlation for metformin hydrochloride sustained-release tablets by deconvolution method
YIN Li-li, LIU Xiao-hong, JIN Ling, SUN Ying-hua, YANG Ya-jun, HE Zhong-gui
(School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract: 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.
Key words: pharmaceutics; in vitro-in vivo correlation; deconvolution method; metformin hydrochloride; plasma concentration; release rate
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