复方盐酸二甲双胍片中格列本脲和二甲双胍溶出度的考察

目的考察并比较自制复方二甲双胍片中格列本脲、二甲双胍与对照药格列本脲片、二甲双胍片的溶出度.方法以HPLC法测定含量,用转篮法测定溶出度,并就溶出度进行比较.结果经检测制剂工艺不同的格列本脲、二甲双胍体外溶出度均符合<中国药典>2005年版的规定,但溶出参数各不相同.结论经统计学处理,因制剂工艺不同,复方二甲双胍片中格列本脲溶出度有显著性差异而二甲双胍溶出度差异不显著.

Investigation on the dissolution rates of glibenclamide and metformin in compound metformin hydrochloride

Objective To investigate the dissolution rates of glibenclamide and metformin in compound metformin hydrochloride. Methods The concentrations of the glibenclamide and metformin were determined by HPLC method. The rotating basket method was used to measure and compare the dissolution rates of glibenclamide and metformin between the compound metformin hydrochloride and conventional tablets. Results The dissolution rates of glibenclamide and metformin with different preparation came up to the standard of CHP (2005), but the dissolution parameters were different. Conclusion The dissolution rate of glibenclamide indicated significant difference between the compound metformin hydrochloride and the conventional tablets, and no significant difference for metformin.