一测多评法同时测定生脉注射液中12个成分

Simultaneous quantitative determination of 12 components in Shengmai Injection by QAMS method

目的建立同时测定生注射液中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Rb;为参照物,建立其它11个成分人参皂苷Rg;、Re、Rf、Rb;、Rh;、Rc、Rb;、Rb;、Rd、20(S)-Rg;及五味子醇甲和五味子醇乙的相对校正因子(f;),并对f;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;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Rg;、Re、Rf、Rb;、Rh;、Rc、Rb;、Rb;、Rd、20(S)-Rg;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2.0~8.7μg/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(fk/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 fk/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 fk/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—8.7μg/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.