乌金胶囊的质量标准研究

Study on quality standard of Wujin capsules

目的建立乌金胶囊的质量控制方法。方法采用薄层色谱(TLC)法对乌金胶囊中的臣药郁金和使药山楂进行定性鉴别;采用高效液相色谱-蒸发光散射检测(HPLC-ELSD)法测定乌金胶囊中通关藤苷H的含量,色谱柱:Waters Xbridge C18柱(100mm×3.0mm,3.5μm),柱温:35℃,流动相为水-乙腈(50∶50),等度洗脱;流速为0.8 ml/min;采用ELSD检测器进行检测,蒸发器温度:35℃,雾化器温度:60℃,氮气流速:1.50L/min,运行时间:5min。结果 TLC法鉴别郁金、山楂,色谱斑点清晰,阴性样品无干扰;通关藤苷H出峰时间为2.98min,且在11.60~580.00μg/ml范围内线性关系良好(r=0.999 0),加样回收率为101.54%。结论本实验建立的TLC法鉴别郁金、山楂,操作步骤简单;建立的HPLCELSD联用方法专属性强,灵敏度高,重复性好,可作为乌金胶囊质量控制的方法。

Objective To establish the qualitative and quantitative analytic method for quality control of Wujin capsules.Methods Curcuma wenyujin Y.H.Chen et C.Ling and Crataegus pinnatifida Bge.in Wujin capsules were identified by TLC method.The content of tenacissoside H was determined by HPLC.Chromatographic separation was achieved at Waters Xbridge C18 column （100 mm＆#215; 3.0 mm, 3.5 μm） with an evaporative light scattering detector （ELSD）.Acetonitrile and H2O were used as the mobile phase for isocratic elution.Results The qualitative identification by TLC was specific.The well separated clear spots were exhibited on each thin layer plate.Tenacissoside H had a linear equation in the range of 11.60-580.00 μg/ml（r=0.999 0）.The average recovery was 101.54%.Conclusion The TLC identification of Curcuma wenyujin Y.H.Chen et C.Ling and Crataegus pinnatifida Bge.was simple and well established.The HPLC-ELSD method was specific,sensitive and reliable.Those methods can be used for the quality control of Wujin capsules.