基于一测多评法的人参叶药材、提取物及制剂中皂苷测定方法研究

目的: 建立人参叶药材、人参茎叶总皂苷、消糜栓、益心宁神片的一测多评含量测定方法。方法: 测定人参叶药材的特征图谱,以人参皂苷Re为参照物建立其与人参皂苷Rg₁、Rb₂、Rd的相对校正因子(RCF),并进行含量测定,实现一测多评(计算法);分别采用外标法测定该4种皂苷含量(实测法),并对2种方法计算结果进行对比分析。结果: 2种方法测定结果无显著差异,测定4种皂苷含量的相对误差小于1.5%。一测多评法,以人参皂苷Re为参照物,人参皂苷Rg₁、Rb₂、Rd的相对校正因子分别是1.79、2.80、3.03;人参叶药材、人参茎叶总皂苷、消糜栓、益心宁神片的一测多评含量测定结果与外标法测定结果无明显差异(RSD<2%)。结论: 本研究建立的以人参皂苷Re为参照物的一测多评法适用于测定人参叶药材、提取物及相关制剂中皂苷类成分的含量,该方法准确、简便、可行。

Objective: To establish an HPLC method for ginsenoside assay of Ginseng Folium medicinal materials,total saponins of Ginseng stem and leaf,Xiaomi suppository,and Yixin Ningshen tablets by quantitative analysis of multi-components by single-marker(QAMS). Methods: Fingerprint determination of Ginseng Folium medicinal materials was conducted with ginsenoside Re as the internal reference substance and the relative correction factors(RCFs)of ginsenosides Rg₁, Rb₂ and ginsenoside Rd were calculated.The external method(the actual measurement method)was also adopted to determine the contents of the four saponins.And the results by the two methods were compared and analyzed. Results: The determination results by the two methods had no significant differences,as the relative error of determination of 4 saponin contents was less than 1.5%.RCFs of ginsenosides Rg₁,Rb₂,Rd were 1.79,2.80 and 3.03 by QAMS method using ginsenoside Re as the reference.The quantitative results of Ginseng Folium medicinal materials,total saponins of Ginseng stem and leaf,Xiaomi suppository,Yixin Ningshen tablets by QAMS method and external standard method had no significant difference(RSD<2%). Conclusion: The QAMS method established in this research is accurate,simple and practical.Therefore,this method is suitable for determination of content of saponins in Ginseng Folium medicinal materials,extracts and related preparations.