基于UPLC及一测多评法同时测定苁蓉总苷胶囊中的活性成分

Determination of Active Constituents in Congrong Zonggan Capsule by UPLC and QAMS

目的:采用"一测多评"(QAMS)技术建立超高效液相法(UPLC)同时测定苁蓉总苷胶囊中6种成分的分析方法,并与标准曲线法进行比较,评价一测多评法用于苁蓉总苷胶囊质量控制的技术适应性和应用可行性。方法:以苁蓉总苷胶囊为研究对象,有机酸类成分以绿原酸为内参物,建立其与咖啡酸的相对校正因子;苯乙醇苷类成分以毛蕊花糖苷为内参物,建立其与管花苷A,异毛蕊花糖苷,松果菊苷间的相对校正因子,同时考察了各相对校正因子的耐用性,并比较该方法与标准曲线法测定结果的差异,以验证一测多评法的准确性和可行性。结果:有机酚酸类成分绿原酸与咖啡酸的相对校正因子为0.538,苯乙醇苷类成分毛蕊花糖苷与管花苷A,异毛蕊花糖苷,松果菊苷间的相对校正因子分别为1.346,1.266和1.135,各相对校正因子的耐用性较好,10批样品QAMS法的计算结果与标准曲线法的测定结果无显著性差异,实验所得的相对校正因子可信。结论:QAMS法可以作为一种简便可靠的质量评价模式用于苁蓉总苷胶囊多种成分的定量测定方法。

Objective： To establish a quantitative analysis for the determination of the six components in Congrong Zonggan capsule based on multi-components with a single-marker（QAMS） method and ultra-high performance liquid chromatography（UPLC）,and compare with the standard curve method,in order to evaluate the adaptation and application of QAMS method in the quality control of Congrong Zonggan capsule. Method：Chrlorogenic acid and acteoside were used as the internal reference substances. The relative correlation factors（RCF） of caffeic acid with chrlorogenic acid,as well as tubuloside A,isoacteoside and echinacoside with acteoside were calculated and established. At the same time,the durability of each RCF was investigated. The results were compared with those obtained by the standard curve method,in order to verify the accuracy and feasibility of the method. Result： Within the linear ranges,the RCF values of chlorogenic acid with caffeic acid was 0. 538,and that of acteoside with tubuloside A,isoacteoside and echinacoside were 1. 346,1. 266 and 1. 135,respectively.The durability of each RCF was good. The two methods showed no significant difference in assay results for the 10 batches of samples. The obtained RCF was credible. Conclusion： The QAMS method is feasible and credible,and could be used to determine the multiple components in Congrong Zonggan capsule.