芪术益肝颗粒的质量标准研究  

Quality Standard of Qizhu Yigan Granule

作　　者：朱庆丰[1] 

机构地区：[1]四川省第二中医医院制剂室,四川成都610031

出　　处：《中医药学报》2015年第3期84-86,共3页Acta Chinese Medicine and Pharmacology

摘　　要：目的：建立芪术益肝颗粒的质量标准，为控制芪术益肝颗粒质量提供依据。方法：采用薄层色谱法对芪术益肝颗粒中黄芪药材进行鉴别，用高效液相色谱对活性成分黄芪甲苷的含量进行测定，色谱柱为C18柱（4．6mm ＆#215;250mm，5μm）；流动相为乙腈－水（40∶60）；进样量为20μL；流速为1．0mL／min；检测器为蒸发光散射检测器，基本参数：氮气流速为1．5 L／min、漂移管温度为55℃。结果：薄层鉴别斑点清晰无干扰，黄芪甲苷在0．052～10．4μg／L范围内呈现良好的线性关系，阴性无干扰，加样回收率为99.8％，RSD值为2．17％。结论：建立的方法操作简单、专属性和重复性良好，可作为芪术益肝颗粒的质量控制方法。Objective：To establish the quality standard of Qizhu Yigan Granule and to provide the basis for the quality control of Qizhu Yigan granule.Methods： TLC was used to identify Radix Astragali from Qizhu Yigan granule for the content of active ingredients of Chinese herbal medicine.Astragaloside was determined by high performance liquid chro-matography, C18 column （4.6mm ＆#215;250mm,5μm）; acetonitrile water was as mobile phase （40∶60）;sample size was for 20μL;the flow rate was 1 .0 mL/min;the basic parameters of detector and evaporative light scattering detection：ni-trogen flow rate was 1 .5 L/min and the drift tube temperature was 55℃.Results：TLC spots were clear without interfer-ence,and astragaloside showed a good linear relationship in the range of 0.052~10.4μg/L,with no negative interfer-ence.The rate of recovery was 99 .8%and RSD value was 2 .17%.Conclusion：The method has a good specificity and repeatability, simple operation, and can be used as the quality control of Qizhu Yigan granule.

关 键 词：芪术益肝颗粒 薄层色谱 高效液相色谱 黄芪甲苷 

分 类 号：R283.6[医药卫生—中药学]