参芪肝康片(胶囊)质量标准研究

Quality Standard for Shenqi Gankang Tablets(Capsules)

目的：研究修订参芪肝康片（胶囊）的质量标准。方法：采用薄层色谱法对制剂中当归、黄芪及五味子进行定性测定;采用高效液相色谱法对绿原酸进行定量测定,采用C18柱,流动相为乙腈-0.4%磷酸溶液（8：92）,检测波长为327 nm。结果：薄层色谱斑点清晰,分离度好,阴性无干扰。含量测定中绿原酸在201 000 mg的范围内线性关系良好（r=0.999 9）,片剂和胶囊剂的加样回收率分别为95.2%、102.4%。结论：修订方法简便、准确,进一步完善了参芪肝康片（胶囊）的质量标准,可作为两者的质量控制标准。

Objective：To improve the quality standard for Shenqi Gankang tablets and capsules.Method：TLC was used to identify Radix Angelicae Sinensis,Radix Astragali and Fructus Schisnndrae Chinensis,and chlorogenic acid was determined by HPLC with a C18 column,the mobile phase of acetonitrile-0.4%pliosphoric aeid（8：92） and the detection wavelength at 327 nm.Result：The herbs could be identified by TLC.For chlorogenic acid,the linear range was from 20 to 1 000 ng,and the average recovery for Shenqi Gankang tablets and capsules was 95.2%and 102.4%,respectively.Conclusion：The method is simple and accurate,and can be used to control the quality of Shenqi Gankang tablets and capsules.