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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。
Objective To compare the quality differences between 8 glimepiride tablets and provide a reference for clinical use. Methods According to the method of appendix of “Pharmacopoeia of the People’s Republic of China (the Second Part)” in 2010, the weight difference, disintegration time, content uniformity, dissolution rate and related substances of tablets from different manufacturers were examined. Urea and its related substances glimepiride sulfonamide, glimepiride carbamate content. Results The weight differences of the 8 glimepiride tablets were all within ± 4% and the disintegration time was less than 15 min. The related substances and content uniformity were in accordance with the quality standards, but the difference in dissolution was statistically significant. Conclusion There are certain differences in the quality of glimepiride tablets among different manufacturers.