一测多评法在冬菊利咽合剂质量控制中的应用研究

目的建立一测多评法同时测定冬菊利咽合剂中绿原酸、木犀草苷和3,5-O-二咖啡酰基奎宁酸3种成分的含量。方法采用HPLC:Agilent TC-C₁₈(2)色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,流速1.0 mL·min^-1,柱温30℃,检测波长334 nm;以绿原酸为内参物,建立其与木犀草苷、3,5-O-二咖啡酰基奎宁酸之间的相对校正因子(f_s∕i);采用外标法测定冬菊利咽合剂中绿原酸的含量,通过f_s∕i计算冬菊利咽合剂中其他2种成分的含量,并将一测多评法与外标法测得的实验结果进行t检验,验证一测多评法的准确性。结果各成分的fs/i适用性和重复性良好,采用一测多评法和外标法的测定值无显著差异。结论本实验所建立的一测多评法可用于冬菊利咽合剂的定量分析和质量评价。

Study on the Application of Quality Control in Dongju Liyan Mixture by QAMS

OBJECTIVE To establish an analysis method of QAMS for simultaneous determination for three active components in Dongju Liyan mixture including chlorogenic acid,cynaroside and 3,5-O-dicaffeoylquinic acid.METHODS HPLC method was used and the analysis was performed on Agilent TC-C18(2)(4.6 mm×250 mm,5μm)column.The mobile phase was acetonitrile-0.1%H3PO4 solution with gradient elution.The flow rate was 1.0 mL·min^-1.The column temperature was 30℃and the detection wavelength was 334 nm.The relative correction factors(fs/i)of chlorogenic acid as internal reference to cynaroside and 3,5-O-dicaffeoylquinic acid were calculated.The content of chlorogenic acid was determined by external standard method and two other components were calculated by fs/i in Dongju Liyan mixture.The results between external standard method and QAMS method were compared with t-test to verify the accuracy of QAMS method.RESULTS The results showed that the fs/i had good system applicability and reproducibility,and there was no significant difference between external standard method and QAMS method.CONCLUSION The QAMS method established can be used for quantitative analysis and quality evaluation of Dongju Liyan mixture.