一测多评法同步测定天泰1号胶囊中多种人参皂苷的含量

Simultaneous Quantitative Analysis of Ginsenosides in Tiantai No.1 by Multi-Components Assay using Single-Marker

目的建立天泰1号胶囊中5种人参皂苷一测多评(QAMS)的质量控制方法。方法以天泰1号胶囊为研究对象,以人参皂苷Rb_1为内参物,计算天泰1号胶囊中人参皂苷Rg_1、Re、Rf、Rd与人参皂苷Rb_1间的相对校正因子(RCF),通过RCF计算天泰1号胶囊中其他4种成分的含量,并在5批样品中同时应用外标法和一测多评法测定5种人参皂苷的含量,验证一测多评法检测结果的可靠性。结果人参皂苷Rg_1、Re、Rf、Rb_1、Rd分别在1.128~11.28μg、1.224~12.24μg、1.094~10.94μg、1.406~14.06μg、1.496~14.96μg范围内线性关系良好;以Rb_1为内参物,制剂中人参皂苷Rg_1、Re、Rf、Rd的RCF分别为0.906,0.963,1.092,1.041。QAMS法和外标法测定值的相对误差(RE)<3.0%,无显著差异。结论所建立的QAMS法可准确测定天泰1号胶囊中多种人参皂苷成分,为本品提供一种简便、准确、低成本的质量控制方法。

Objective To establish a new quantitative analysis of multi-components by single marker（QAMS）method for the determination of five ginsenosides in Tiantai No.1. Methods Adopting the QAMS quality evaluation model for Tiantai No.1, ginsenoside Rb_1 was used as the internal reference substance, and the relative correction factors（RCF）of ginsenosides Rg_1,Re,Rf and Rd to ginsenoside Rb_1 were calculated individually. The quantitative results were compared with those obtained by the external standard mothod in 5 batches of Tiantai No.1. Results Ginsenosides Rg_1,Re,Rf,Rb_1,Rd had good linear relations within the ranges of 1.128-11.28,1.224-12.24,1.094-10.94,1.406-14.06,1.496-14.96 μg,respectively. Within the linear ranges,the RCF values of ginsenoside Rg_1,Re,Rf,Rd to Rb_1 were 0.906,0.963,1.092 and 1.041 respectively; no significant differences were found in the quantitative results of five ginsenosides between external standard method and QAMS（RSD 3.0 %）. Conclusion The QAMS method is feasible,credible,and could be used to determine the multiple ginsenosides components in Tiantai No.1.