提高黔淫羊藿的质量标准研究

Study on the improvement of the quality standard of Epimedium qianensis

目的 进一步完善黔淫羊藿的质量标准。方法 对黔淫羊藿进行显微鉴别,按2020年版《中华人民共和国药典》(四部)相应方法对水分、灰分及浸出物进行测定,优化薄层色谱法(TLC),用高效液相色谱法(HPLC)对淫羊藿苷和朝藿定C进行含量测定。结果 显微鉴别特征明显;供试品薄层色谱中,在与对照品相应位置显相同颜色的斑点;水分含量为9.23%~9.97%;总灰分含量为5.20%~6.89%;浸出物含量为12.42%~25.10%;淫羊藿苷和朝藿定C的质量浓度分别在2.50~49.95、10.27~205.38μg·mL范围内与其峰面积值呈良好的线性关系(R^(2)=0.999 9),朝藿定C的平均回收率为101.6%,RSD=0.22%;淫羊藿苷的平均回收率为93.72%,RSD=0.21%。结论 修订后的质量标准更加完善,薄层鉴别方法专属性强,HPLC法精密度高,重复性好,可用于黔淫羊藿的质量控制。

Objective To further improve the quality standards of Epimedium qianensis.Methods Microscopic identification was used to study Epimedium qianensis medicinal materials. According to the corresponding methods of the Chinese Pharmacopoeia(2020 edition, Part Four), the moisture, ash and extracts of Epimedium qianensis medicinal materials were studied, and the thin-layer chromatography(TLC) was optimized. A high performance liquid chromatography(HPLC) was established to determine the ingredients of icariin and chaicidine.Results The experiment findings showed that the microscopic identification of Epimedium qianensis was obvious. In TLC, the same color spots appeared in the corresponding position of the reference product;the moisture content was 9.23%-9.97%;the total ash content was 5.20%-6.89%;the extract content was 12.42%-25.10%. The amounts of icariin and epmedin C in the range of 2.50-49.95 μg·mLand 10.27-205.38 μg·mLshowed a good linear relationship with their peak areas(R^(2)=0.999 9);the average recovery rates of epmedin C and icariin were 101.6%, and 93.72%, with RSD=0.22% and RSD=0.21%, respectively.Conclusion The revised quality standard can be used for better controlling the quality of Epimedium qianensis.