通胞消瘕合剂的质量标准研究

Study on Quality Standers for Tongbao Xiaojia Mixture

目的:建立通胞消瘕合剂质量标准。方法:采用薄层色谱法(TLC)对甘草、黄芩进行定性鉴别,以高效液相色谱法(HPLC)对主药金银花中绿原酸进行含量测定,色谱柱为色谱柱Agilent ZORBAX Eclispse SB-Aq C18柱(4.6 mm×250 mm,5μm);流动相乙腈-0.4%磷酸(7∶93);流速1.0 mL·min;柱温30℃;检测波长327 nm。结果:通胞消瘕合剂中甘草、黄芩的TLC色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点。绿原酸含量测定线性关系良好,回归方程Y=1.06×105 X-1.00×104,r=0.999 9,绿原酸的平均回收率为100.47%,RSD为1.50%。结论:方法简便、准确、灵敏、重复性好,可作为通胞消瘕合剂质量控制。

Objective： To develop quality standards of Tongbao Xiaojia mixture.Method： Thin layer chromatography（TLC） of Licorice root,Radix Scutellariae were identified according to high performance liquid chromatography（HPLC） of the main drug of chlorogenic acid determination,chromatographic column was Agilent ZORBAX Eclispse SB-Aq C18 column（4.6 mm × 250 mm,5 μm） column;mobile phase acetonitrile-0.4% phosphoric acid（7∶93）;flow rate 1.0 mL.min;column temperature 30 ℃;detection wavelength 327 nm.Result： Tongbao Xiaojia Mixture Licorice root,Radix Scutellariae TLC chromatography,chromatography with reference substance corresponding location on the same color of the spots.Determination of chlorogenic acid good linear relationship,the regression equation Y = 1.06 × 10^5X-1.00 × 10^4,r = 0.999 9,chlorogenic acid,the average recovery was 100.47%,RSD to 1.50%.Conclusion：This method is simple,accurate,sensitive,reproducible and can be used as quality control Qingyan Liyan mixture