“一测多评”法在银翘散质量控制中的应用

Quality Control for Yinqiao Powder Based on Quantitative Analysis on Multi-components with Single Marker

目的:采用一测多评法对银翘散中绿原酸、连翘苷、连翘酯苷A和牛蒡苷4种成分同时进行含量测定。方法:采用高效液相色谱法,检测波长为230nm,在一定线性范围内,以牛蒡苷为参照、测定银翘散中绿原酸、连翘酯苷A及连翘苷的相对校正因子,并考察不同仪器、不同色谱柱测定各成分相对校正因子的重现性;同时采用外标一点法测定银翘散中4种成分的含量、并与一测多评法测定结果比较,验证一测多评法的可行性和准确性。结果:绿原酸、连翘酯苷A及连翘苷的相对校正因子重复性较好,采用一测多评法计算10批银翘散中绿原酸、连翘苷、连翘酯苷A和牛蒡苷含量与外标一点法实测值之间相对偏差均在3%以内。结论:该方法准确可靠,简便可行,且节约对照品及检测成本,可以作为银翘散多指标成分测定质量控制方法。

Objective:To establish a method of quantitative analysis of multi-components by single marker(QAMS)to assay several components in Yinqiao powder.Methods:To assay a relative correction factor(RCF)of chlorogenic acid,forsythin,forsythoside A and arctiin fromYinqiao Powder at detection wavelength of 230 nm by HPLC in the range of a linear and to investigate the reproducibility of RCF of different instruments and different chromatographic columns.At the same time,determination of 4 components in San Yinqiao was performed with one point external standard method and QAMs method in comparison with the determined results,and then to verify the accuracy and feasibility of QAMS method.Results:The RCF of reproducibility was desirable,and the components including chlorogenic acid,forsythin,forsythoside A and arctiin content were successfully determined by QAMS from 10 batches of Yinqiao Powder.The difference of the measured value was within 3%compared with that by one point external standard method,without significant difference.Conclusion:The QAMS method is accurate and reliable,simple and feasible which can be used as Yinqiaopowder multi-components determination method of quality control.