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

作　　者：曾永长 梁少瑜[1,2,3] 俞励平 李映红[1,2] 陈飞龙[5] 吴正治 

机构地区：[1]深圳市老年医学研究所,广东深圳5180201 [2]深圳市第二人民医院,广东深圳518035 [3]暨南大学,广东广州510632 [4]中山大学药物开发中心,广东广州510080 [5]南方医科大学中医药学院,广东广州510515

出　　处：《中药新药与临床药理》2017年第6期792-796,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省科技厅公益研究与能力建设专项资金新药创制专题项目(2015B020211001);深圳市科技计划项目(JCYJ20160428105555220)

摘　　要：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.

关 键 词：天泰1号胶囊 人参皂苷 一测多评 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]