一测多评法同时测定注射用血栓通(冻干)中5个主要皂苷含量

目的：建立一测多评法（QAMS法），用于测定注射用血栓通（冻干）中三七皂苷R₁及人参皂苷Rg₁、Re、Rb₁、Rd 5种主要皂苷成分的含量。方法：先采用UPLC外标法测定三七皂苷R₁的含量，再计算该成分与人参皂苷Rg₁、Re、Rb₁及Rd的相对校正因子，并进行含量计算，通过方法学验证及各成分外标法含量测定结果比较，验证一测多评法的准确性；色谱条件：采用BEH C₁₈（2.1 mm&#215;100 mm，1.7 μm）色谱柱，以水（A）-乙腈（B）为流动相，梯度洗脱，流速0.5 mL&#183;min^-1，检测波长203 nm，样品室温度15℃，柱温40℃，进样量10 μL。结果：各相对校正因子系统适用性和重现性良好（RSD<2%），采用外标法和一测多评法测定6个批次样品的含量（人参皂苷rg_{1：42.52%~45.61%；人参皂苷Re：5.27%~5.79%；人参皂苷Rb1：23.87%~24.55%；人参皂苷Rd：1.14%~1.78%），经t检验分析，P>0.05，表明没有显著性差异。结论：研究建立的一测多评法可用于注射用血栓通（冻干）中5种主要皂苷类成分的含量测定。}

Objective: To establish a quantitative analysis method of multi-components by single marker(QAMS) in order to determine five major saponins in Xueshuantong for injection(lyophilization)including notoginsenoside R₁,ginsenosides Rg₁,Re,Rb₁ and Rd.Methods: UPLC method was utilized and notoginsenoside R₁ was chosen as internal reference standard.Relative correction factors(RCFs)of ginsenosides Rg₁,Re,Rb₁ and Rd to notoginsenoside R₁ were calculated.The contents of the five major saponins in Xueshuantong for injection(lyophilization)were determined by both external standards and QAMS method(ginsenoside Rg₁:42.52%-45.61%;ginsenoside Re:5.27%-5.79%; ginsenoside Rb1:23.87%-24.55%; ginsenoside Rd:1.14%-1.78%).The method validation and the content determination results between the two methods were investigated.The chromatographic conditions were as follows:BEH C18(2.1 mm&#215;100 mm,1.7 μm)column was used,the mobile phase consisted of water(A)-acetonitrile(B)with gradient elution at a flow rate of 0.5 mL&#183;min^-1 under the column temperature of 40℃, and the sample injected volume was 10 μL under 15℃, the detect wavelength was set at 203 nm.Results: The results showed that the RCF had good system applicability and reproducibility(RSD<2%), and="" there="" was="" no="" significant="" difference="" between="" external="" standard="" method="" qams="" by="" p="">0.05).Conclusion: The QAMS method established can be used for quality control of Xueshuantong for injection (lyophilization)

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