舒神灵胶囊质量标准研究

Quality standard of the Shushen Ling capsules

目的：建立舒神灵胶囊质量标准。方法：采用薄层鉴别方法进行定性鉴别,运用高效液相色谱法测定大黄素的含量。结果：确立了制剂中五味子、北合欢的鉴别方法。通过方法学系统考察,建立了大黄素的含量测定方法,其大黄素的线性范围为0.0265~0.212μg,回归方程为Y=40.90421X＋2.58308（r=0.99996）,平均加样回收率为100.1%,RSD为1.56%（n=6）。结论：建立的鉴别和含量测定方法简便、准确、重复性好,适用于质量控制。

Objective： To establish the quality standards for Shushen Ling capsules. Methods： The thin layer chromatography （TLC） was adopted for qualitative identification; the content of emodin was detected by HPLC. Results： The identifying method of schisandra chinensis and north meadow were established. The determination method for the content of emodin was established. The calibration curve of emodin was liner in the range of 0.0265~0.212μg. The regression equation wasY=40.90421X＋2.58308（r=0.99996）. The average recovery efficiency was 100.1%, and RSD was 1.56% （n=6）. Conclusion： The method is simple, accurate and reproducible. It can be used for the quality control.