至清胶囊的质量标准

Study on Quality Standard for Zhiqing Capsules

目的：建立至清胶囊质量标准。方法：采用TLC法鉴别方中的山楂、葛根、绞股蓝和银杏叶提取物,采用HPLC法测定制剂中葛根素的含量。结果：薄层色谱清晰,分离效果好,阴性无干扰;葛根素在55~1 100 ng范围内与峰面积呈良好的线性关系（r=0.999 5）,平均回收率为99.32%,RSD=0.91%（n=6）。结论：方法简便、准确、稳定且无干扰,可作为该制剂的质量控制方法。

Objective： To establish the quality standard for Zhiqing capsules. Method： Crataegus pinnatifida, Radix Puerariae, Fiveleaf Gynostemma Herb, and Ginkgo biloba P. E were identified by TLC. The content of puerarin was determined by HPLC. Result： The spots in the TLC were clear without interference from the negative control. The linear range of puerarin was 55-1 100 ng（ r = 0. 999 5 ）. The average recovery was 99.32% with RSD of 0.91% （ n = 6）. Conclusion： The method is simple, accurate, reliable and reproducible with high specificity, and can be used as the quality control standard for Zhiqing capsules.