更安颗粒的质量标准研究

Quality Standard of Gengan Granule

目的建立更安颗粒的质量控制方法。方法采用薄层色谱法(TLC)对更安颗粒中的淫羊藿、丹参、首乌藤、黄芩进行定性鉴别;采用高效液相色谱法测定淫羊藿苷的含量。结果 TLC可鉴别出上述各组分与对照品相应的斑点,且阴性对照无干扰。淫羊藿苷在0.0116～1.0300mg·mL-1线性关系良好(r2=0.9997),平均加样回收率为:98.35%,RSD=1.23%(n=6)。结论该方法操作简便,方法稳定,可作为该制剂的质量控制方法。

Objective To establish a method for quality control of gengan granule. Methods Herba epimedii, Salvia miltiorrhiza,Caulis polygoni multiflori,Radix scutellariae were identified by TLC. The content of icariin was determined by HPLC. Results The spots of components mentioned above and the control were detected by TLC,and no interference by the negative sample occured. The linear ranges of icariin were 0. 0116 ～ 1. 03 mg·mL-1 （ r2 = 0. 999 7） ,and the average recovery was 98. 35% ,RSD = 1. 23% . Conclusion The established method is simple,feasible and repeatable,and can be used for the quality control of gengan granule.