芪桂痛风片的质量标准研究

Quality control of Qinguitongfeng tablets

目的:研究并建立芪桂痛风片的质量标准。方法:采用薄层鉴别方法进行定性鉴别,运用高效液相色谱-蒸发光散射(HPLC-ELSD)法测定黄芪甲苷的含量。结果:确定了制剂中黄芪、秦皮、浙贝母的鉴别方法。通过方法学系统考察,建立了黄芪甲苷的含量测定方法,黄芪甲苷的质量浓度线性范围为30.66~998.00μg·m L^(-1),回归方程Y=1.481 3X+0.211 2,r=0.999 6,平均加样回收率为99.54%,RSD为1.96%。结论:建立的鉴别和含量测定方法简便可行,专属性强,重现性好,可作为芪桂痛风片的质量控制方法。

Objective： To establish the quality standards for Qinguitongfeng（QGTF） tablets. Methods：The thin layer chromatography（TLC） was adopted for qualitative identification; astragaloside IV was detected by HPLC-ELSD. Results： The identifying methods of Astragalus,Fritillary bulb,and Fraxini Cortex,as well as determination method for the content of Astragaloside IV,were established. The calibration curve of Astragaloside IV was linear between 30. 66 ~ 998. 00 μg·m L^-1. The regression equation was Y = 1. 481 3X ＋ 0. 211 2,r = 0. 999 6.The average recovery was 99. 54%,and RSD was 1. 96%（n = 9）. Conclusion： This method is simple,reproducible and feasible,and can be used for the quality control of QGTF tablets.