目的建立一种简单的一测多评方法同步计算测定三种人参产品(人参茎叶总皂苷、人参皂苷三醇组、血塞通注射液)中多种皂苷成分。方法:测定人参总皂苷的指纹图谱,以人参皂苷-Rb1为基准峰,分别计算人参皂苷-Rg1、-Rb1、-Rc、-Rb2、-Rd与其的相对校正因子(RCF),外标法测定人参皂苷-Rg1、-Re、-Rb1、-Rc、-Rb2及-Rd的含量,用校正因子计算总皂苷的含量;一测多评法结果、RCF为1的结果与外标法测定结果进行比较。测定不同批号的血塞通注射液,以验证方法可行性和科学性。并对不同品牌填料及不同长度的色谱柱进行考查,评价一测多评法在复方制剂中应用的准确性和科学性。结果建立了人参总皂苷含量的简便测定方法,以一测多评法计算含量,结果与外标法结果之间的变异系数分别为0.07%、0.32%、0.14%,另外以人参皂苷-Re的RCF值为1计算测定含量,结果与外标法测定结果之间的变异系数分别为1.53%、3.87%、2.11%,三种方法无显著性差异。三种方法测得9个不同批号的血塞通注射液的总皂苷含量无明显差别,RSD〈5%。结论用本法只采用人参皂苷-Re对照品即可同时控制多种成分的含量,又能节约对照品的使用,适合中药的多指标质量评价模式的要求。
Aim: To establish a simple convenient HPLC method for quantitative determination of ginsenosides in three ginseng products(total saponins of ginseng leaves,panaxtriol type ginsenosides and Xue-Sai-Tong injection) by using one marker to calculate multi-components simultaneously.Methods: Using ginsenoside-Rb1 as the contrast,the relative correction factors(RCF) of the other five ginsenosides were determined by HPLC.Using the RCFs to calculated total saponins,and compared with the simplicity QAMS method and external standard method.Determine in 9 batches of Xue-Sai-Tong injections to validate.The accuracy of the new method was evaluated by comparing the calculated contents with the determined Results: Compared with external standard method(ESM),the variation coefficients of total ginsenosides calculated with the RCFs in the three ginseng products were 0.07%,0.32%,0.14% respectively.In addition,to facilitate the determination,the contents of total ginsenosides were calculated with the RCFs seemed as 1.0,and the variation coefficients were 1.53%,3.87%,2.11% when the RCFs contrasted with ginsenoside-Re.There are no differences among the QAMS method,the simplicity QAMS method and external standard method for determination in 9 batches of Xue-Sai-Tong injections,RSD 5%.Conclusion: The method of multi-components quantitation by one reference substance can determine multicomponents simultaneously and save the chemical reference substance.It is to be a new quality evaluation pattern for Chinese herbal medicines.