肝复康丸质量标准研究

Study on Quality Standard of Ganfukang Pills

目的建立肝复康丸的质量标准。方法采用薄层色谱(TLC)法对五味子和白花蛇舌草进行定性鉴别,用高效液相色谱(HPLC)法测定五味子醇甲含量。结果定性鉴别分离度好、专属性强;五味子醇甲质量浓度在6.68～33.40μg/mL范围内与峰面积线性关系良好,r=0.99997(n=5),平均回收率为99.97%,RSD为0.98%(n=6)。结论该法操作简便、结果准确、重现性好,适用于肝复康丸的质量控制。

Objective To establish the quality standard of Ganfukang Pills. Methods TLC was performed to identify Schizandra Chinensis （Turcz） Bills and Oldenlandia diffusa （willd） Roxb. HPLC was used to determine schizandrin. Results The study on the quality control showed that the characteristic of identification by TLC was distinct and highly specific. The linear correlation emerged within the range of 6. 68 - 33. 40 μg/mL, r=0. 99997（n=5）.The average recovery rate was 99.97%,and RSD was 0.98% （n=6）.Conclusion The method is simple, accurate, reproducible. It can be used as the quality control method for Ganfukang Pills.