盐酸二甲双胍缓释片处方前研究

Preformulation study on metformin hydrochloride sustained release tablet

建立盐酸二甲双胍片剂的含量测定和溶出度测定方法.采用紫外分光光度法进行片剂质量浓度、溶出度和溶解度测定,结果表明在1.150-10.260μg/mL范围内,线形关系良好,精密度和回收率符合要求.建立的方法适用于二甲双胍片剂的处方前研究.

To establish the method of dissolution of metformin hydroehloride （ MH ） tablet. The linear relation was good under the range of 1. 150～10.260 μg/mL ,average accuracy and precision were accord to the standards. The method is specific, convenient and accurate. It can be used for the pre-formulation design of metformin hydrochloride tablet.