8种格列美脲片剂的质量比较

Comparison of the quality of eight glimepiride tablets

目的比较8种格列美脲片之间的质量差异,为临床用药提供参考。方法依据2010版《中华人民共和国药典(二部)》附录中方法对不同厂家片剂的重量差异、崩解时限、含量均匀度、溶出度以及有关物质等进行检查,采用HPLC法测定格列美脲及其有关物质格列美脲磺酰胺、格列美脲氨基甲酸酯的含量。结果 8种格列美脲片剂的重量差异均在±4%内,崩解时限均<15 min,有关物质与含量均匀度均符合质量标准规定,但溶出度差异存在统计学意义。结论不同厂家格列美脲片剂质量之间存在一定的差异。

AIM To compare the quality of eight glimepiride tablets for clinical reference in drug choice. METHODS According to the methods in the appendix of Chinese Pharmacopoeia 2010 （Part II ）, weight variation,disintegration time, content uniformity, dissolution and related substance of glimepiride tablets from different manufactures were in- spected. The contents of glimepiride and its related substances glimepiride sulfonamide and carbamate glimepiride were determined by RP-HPLC. RESULTS Weight variation of eight glimepiride tablets were within ±4%, disintegration time were less than 15 min, related substance and content uniformity were conformable to quality standards. However, dissolution of glimepiride tablets from different manufactures showed more significant differences. CONCLUSION There are certain differences in qualities of glimepiride tablets from different manufactures.