护肝清脂片质量标准研究  

The Quality Standard Study on Hugan Qingzhi Tablets

作　　者：周本杰[1] 严愉妙[1] 黄淑贤[1] 姚育法[1] 张守尧[1] 

机构地区：[1]南方医科大学珠江医院药学部,广东广州510282

出　　处：《中药材》2012年第4期644-647,共4页Journal of Chinese Medicinal Materials

基　　金：广东省中医药局科研课题(2008367);广东省科技计划项目(2010B060900056)

摘　　要：目的:建立中药复方新药护肝清脂片的质量控制方法。方法:采用薄层色谱法对护肝清脂片中的山楂、泽泻、三七进行定性鉴别;采用高效液相色谱法测定该制剂中熊果酸的含量。结果:薄层色谱显色清晰且阴性对照无干扰。熊果酸在40～200μg/mL浓度范围内线性关系良好,r=1.000,平均加样回收率为99.05%,RSD为1.3%。结论:该方法操作简便,结果准确、重复性好,可用于护肝清脂片的质量控制。Objective：To develop a method of quality control for Hugan qingzhi tablets. Methods：Fructus Crataegi,Rhizoma A1- ismatis and Radix Notoginseng were identified by TLC. HPLC was used for the determination of ursolic acid in Hugan qingzhi tablets. Results： The chromatographic spots were identified without the interference of negative control. Ursolic acid had a good linearity over the concentration range of 40-200μg/mL （ r = 1. 000）. The average recoveries was 99.05% with relatively standard deviations of 1.3%. Conclusion： This method is reliable,accurate and specific and can be used for the quality control of Hugan qingzhi tablets.

关 键 词：护肝清脂片 薄层色谱法 熊果酸 高效液相色谱法 

分 类 号：R286.1[医药卫生—中药学]