中文摘要：

目的建立五子衍宗丸（WYP）一测多评的测定方法,并验证该方法在WYP质量控制中的适用性与准确性。方法以WYP为研究对象,以五味子醇甲为内参物,建立金丝桃苷、槲皮苷、山柰酚-3-O-芸香糖苷、五味子甲素、五味子乙素与其之间的相对校正因子（f（s/k））,用fs/k计算各代表性成分量,实现一测多评;同时对一测多评的计算值与外标法实测值进行比较。结果在各自线性范围内,五味子醇甲与金丝桃苷、槲皮苷、山柰酚-3-O-芸香糖苷、五味子甲素、五味子乙素之间的f（s/k）分别为0.36、4.86、0.88、7.34、6.35;且在不同色谱仪和不同色谱柱下有较好的重复性;利用一测多评法在不同色谱柱中的计算值与外标实测值之间没有显著性差异。结论一测多评法可同时对WYP中上述6种成分进行定量测定,该方法简便、准确、可靠,可有效控制WYP的质量。

英文摘要：

Objective To establish a quantitative analysis of multi-component with a single-marker（QAMS） method for the quality control of Wuzi Yanzong Pills（WYP）. Methods Six main effective components（schisandrin, hyperin, quercitrin, kaempferol 3-O-rutinoside, deoxyschizandrin, and γ-schizandrin） of WYP were simultaneously separated on a reversed-phase column（Ultimate LP-C18） with high-resolution of each chromatographic peak by high performance liquid chromatography（HPLC）. Schisandrin was selected as the internal reference, and the relative correlation factors（RCFs） of other five components were calculated to achieve QAMS. The ruggedness of RCFs was tested on different instruments and columns. Moreover, results of the QAMS were compared with the external standard method. Results Within a certain linear range, the RCFs of hyperin, quercitrin, kaempferol 3-rutinoside, deoxyschizandrin, and γ-schizandrin were 0.36, 4.86, 0.88, 7.34, and 6.35, respectively. The repeatability was good under different experimental conditions. There were no significant differences between the calculated value and estimated value on QAMS and external standard method. Conclusion The QAMS method can be used to assay the content of six components of WYP simultaneously and control the quality of WYP simplely, reliably, and accurately.