人参北芪片质量标准的研究

Study on Quality Standard for Renshen Beiqi Tablets

目的:建立人参北芪片的质量控制方法。方法:采用TLC法同时鉴别制剂中的人参及黄芪膏粉,采用HPLC-ELSD方法测定制剂中黄芪甲苷的含量。结果:鉴别方法专属性强,含量测定方法黄芪甲苷在1.060 8～10.608μg之间呈良好的线性关系;人参北芪片中黄芪甲苷的平均回收率为96.4%(RSD 1.3%);结论:该方法简便、准确、分离效果好,可用于人参北芪片的质量评价。

Objective：To establish a quality standard for Renshen Beiqi Tablets. Methods： Thin layer chromatography was used for identification of Ginseng and Astragalus extract powder at the same time. The Astragaloside was determinated by HPLC-ELSD. Results ： The identification study showed strong specificity. The calibration curve was linear in the ranges of 1. 0432 - 10. 432 μg. The average recoveries were 96. 7% （RSD1.2%） o Conclusion： The developed method is simple and accurate. It can be used for quality control for Renshen Beiqi Tablets.