参柴肝康片质量标准研究

目的建立参柴肝康片的质量控制方法。方法采用薄层色谱法鉴别柴胡、人参茎叶皂苷,并且采用HPLC测定人参皂苷Rg1与人参皂苷Re含量。流动相为乙腈—0.05%磷酸溶液(22∶80),色谱柱(DimensionsC18柱,250 mm×4.6 mm),检测波长203nm,柱温10℃。结果柴胡、人参茎叶皂苷薄层色谱斑点清晰,阴性对照无干扰;人参皂苷Rg1、人参皂苷Re分别在1.068~10.680μg(r=0.999 9)与2.186~21.860μg(r=1.000 0)范围内线性关系良好,平均回收率分别为98.68%、99.21%,RSD分别为1.38%、1.41%。结论所建立的质量控制方法,操作简便、专属性强、重现性好,可用于该制剂的质量控制。

Quality standard of shenchai gankang tablets

Objective To establish the quality standard of shenchai gankang tablets.Methods Radix bupleuri and ginsenoside stems and leaves were identified by TLC.HPLC metheod for determining ginsenoside Rg1 and ginsenoside Re was established.Acetonitrile-0.05% phosphoric acid solution（22∶80）as the mobile phases,the detection wavelength was 203 nm,and the column temperature was set at 1 0℃.Results The TLC spots were clear,and there was noninterference of the negative control.The linearity of the concentration of ginsenoside Rg1 and ginsenoside Re and their peak areas were fine in the range of 1 .068-1 0.680 μg （r=0.999 9）and 2.1 86 ~21 .860 μg（r=1 .000 0）.The rates of recovery were 98.68%,and 99.21%,respectively.RSD separately were 1 .38% and 1 .41%, respectively.Conclusions The established quality control method has the advantages of simple operation,strong specificity and good reproducibility,which can be used to control the quality of this preparation.