益气复脉片质量标准研究

Study on Quality Standard of Yiqifumai Tablets

目的:本文主要对益气复脉片的质量标准进行了系统的研究,建立了以高效液相色谱法(HPLC)测定五味子醇甲。方法:比色法测定总皂苷的相关有效成分含量测定方法;另采用薄层色谱(TLC)鉴定了麦冬。结果:益气复脉片含总皂苷的平均值为6．61mg。结论:此质量检测方法的分离度、重复性均好,精密度高,简单快速,建议本品质量标准每片五味子甲醇含量不低于1．4mg;总皂苷含量不低于5mg。

Objective： We did systemtical study on the quality standard of Yiqifumai tablets. The content of schisadrol A in Yiqifumai tables was determined by HPLC. Methods： The content of total saponins in Yiqifumai tables was determined by colormetry. Tuber of Dwarf Lilyturf in Yiqifumai tables were indentified by TLC. Results： The average of total saponins which is contained by yiqifumaitablets is 6.61mg. Conclusion： Seperation and repetition of the method which is determined quality is quite well. Moreover, this method is simple and accuracy. The suggestion is that the content of Schisadrol A in every yiqifumi tablets should be high of 1.42rng and the content of total saponins in every yiqifumai tablets should be high of 5 mg.