健肝乐软胶囊的质量标准控制  

Quality standard for Jianganle soft capsule

作　　者：陈平[1] 陈新[1] 王珲[1] 钱丽娜[1] 张继良 

机构地区：[1]武汉工业学院,湖北武汉430023 [2]武汉康乐药业有限公司,湖北武汉430030

出　　处：《中国医院药学杂志》2007年第11期1528-1530,共3页Chinese Journal of Hospital Pharmacy

基　　金：湖北省教育厅重大科研项目(编号:2004D009)

摘　　要：目的：建立健肝乐软胶囊的质量控制标准。方法：采用薄层色谱法对健肝乐软胶囊中白芍、甘草药材进行定性鉴别；以高效液相色谱法对处方中活性成分芍药苷进行含量测定，色谱柱：Inertsil ODS-3（250mm×4．6mm，5μm）；流动相：乙腈-水（15：85）；检测波长：230nm；流速：3mL·min^-1；柱温：25℃。结果：芍药苷在0．432-3．456μg范围内线性关系良好，r=0．9998，平均回收率为98．76％，RSD为0．63％（n=6）。结论：本方法具有良好的重复性和稳定性，且操作简便，可用于健肝乐软胶囊的质量控制。OBJECTIVE To establish the quality control standard for Jianganle soft capsule. METHODS Radix et Rhizoma Glycyrrhizae and Radix Paeoniae Alba of Jianganle soft capsule were identified by TLC. Paeoniflorin of soft capsule was deter- mined by HPLC. Inertsil ODS-3 C18 （250mm×4.6mm,5μm） colum was used. The mobile phase was acetonitrile-H2O（15： 85）, and UV detection wavelength was at 230 nm, flow rate of 3. 0mL·min^-1. RESULTS The linear range of paeoniflorin was within 0.432-3.456μg（r= 0.9998）. The average recovery was 98.76% and RSD= 0. 63%（n = 6）. CONCLUSION The method has good repeatability and flexibility. It can be used for quality control in production of Jianganle soft capsule.

关 键 词：健肝乐软胶囊 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R283.65[医药卫生—中药学]