目的 建立同时测定生脉注射液中12个成分含量的一测多评（quantitative analysis of multi-components with a single-marker，QAMS）方法。方法 采用HPLC法，以人参皂苷Rb₁为参照物，建立其它11个成分人参皂苷Rg₁、Re、Rf、Rb₁、Rh₁、Rc、Rb₂、Rb₃、Rd、20（S）-Rg₃及五味子醇甲和五味子醇乙的相对校正因子（f_k/s），并对f_k/s进行耐用性考察。采用外标法和QAMS法测定生脉注射液中12个成分含量，比较两者的差异，验证QAMS法的可行性和准确性。结果 各个成分的f_k/s重复性良好，对14份生脉注射液样品运用QAMS法和外标法得到的各成分含量无显著性差异（RSD<3%）；不同厂家、不同批号之间的成分含量差异较大。14份样品中12个成分人参皂苷Rg₁、Re、Rf、Rb₁、Rh₁、Rc、Rb₂、Rb₃、Rd、20（S）-Rg₃及五味子醇甲和五味子醇乙的质量浓度分别为83.3～141.9、85.9～183.2、34.6～64.4、137.0～316.4、47.2～99.1、84.6～235.0、60.9～147.9、9.5～28.7、32.2～117.2、17.4～34.7、9.8～23.9和2.0～8.7 μg/mL。结论 所建立的QAMS法准确性高，可用于生脉注射液多成分的同时定量分析，为生脉注射液的全面质量控制提供方法参考。

Objective To establish a new method of quantitative analysis of multi-components with a single-marker (QAMS) for simultaneously determination of 12 components in Shengmai Injection (生脉注射液, SMI). Methods Ginsenoside Rb₁ was used as the reference to calculate the relative correction factors (f_k/s) of ginsenoside Rg₁, ginsenoside Re, ginsenoside Rf, ginsenoside Rb₁, ginsenoside Rh₁, ginsenoside Rc, ginsenoside Rb₂, ginsenoside Rb₃, ginsenoside Rd, ginsenoside 20(S)-Rg₃, schisandrin and schisandrin B by HPLC, and then the durability of f_k/s was investigated. The feasibility and accuracy of QAMS method were validated by comparing the determination of 12 components in SMI with the external standard method (ESM). Results The repeatability of f_k/s for each component was good. There was no significant difference (RSD < 3%) between the measured values of QAMS method and ESM. There were significant difference in the components contents of SMI from different manufacturers and different batch numbers. The concentrations of ginsenoside Rg₁, Re, Rf, Rb₁, Rh₁, Rc, Rb₂, Rb₃, Rd, 20(S)-Rg₃, schisandrin and schisandrin B in 14 SMI samples were 83.3-141.9, 85.9-183.2, 34.6-64.4, 137.0-316.4, 47.2-99.1, 84.6-235.0, 60.9-147.9, 9.5-28.7, 32.2-117.2, 17.4-34.7, 9.8-23.9 and 2.0-8.7 μg/mL, respectively. Conclusion The established QAMS method has high accuracy and it can be used for the simultaneous quantitative determination of multiple components in SMI. This method will provide a method reference for the comprehensive quality control of SMI.

R286.02

国家自然科学基金资助项目（81503338）；浙江省自然科学基金资助项目（LGF22H280004）；浙江省自然科学基金资助项目（LY18H280011）；嘉兴市科技计划项目（2018AD32102）；嘉兴学院重点SRT项目（CD8517213303）；第二批嘉兴市省市共建医学重点学科—心血管病学（2019-ss-xxgbx）；心肌缺血的基础与临床研究创新团队（2018-xjqxcxtd）