目的 建立用于测定注射用益气复脉（冻干）（YFI）中9种成分人参皂苷Rb₁（Rb₁）、Rg₁（Rg₁）、Re（Re）、Rf（Rf）、Rc（Rc）、Ro（Ro）、Rb₂（Rb₂）、Rd（Rd）及五味子醇甲（Sch）的一测多评（QAMS）方法，探讨QAMS法用于不同类型化学成分定量测定的准确性与可行性。方法 采用高效液相色谱法，Diamonsil^® C₁₈（2）（250 mm×4.6 mm，5 μm）色谱柱，乙腈-0.05%磷酸水溶液为流动相，梯度洗脱，柱温30℃，体积流量为1 mL/min，检测波长203 nm。建立Rg₁、Re、Rf、Rc、Ro、Rb₂、Rd及Sch与内参物Rb₁的相对校正因子（f），通过f计算YFI中8种成分的量，并在25批YFI中进行验证，将该方法与外标法测定的结果进行对比分析，以验证QAMS法的合理性、可行性和可重复性。结果 Rg₁、Re、Rf、Rb₁、Rc、Ro、Rb₂、Rd、Sch分别在进样量为0.929~4.644、0.818~4.089、0.732~3.660、1.461~7.305、0.636~3.181、0.618~3.092、0.788~3.941、0.758~3.789、0.178~0.889 μg线性关系良好，加样回收率为97.08%~100.94%；f值分别为f_Rg1/Rb1=1.970，f_Re/Rb1=0.929，f_Rf/Rb1=1.196，f_Rc/Rb1=0.870，f_Ro/Rb1=0.830，f_Rb2/Rb1=0.786，f_Rd/Rb1=0.906，f_Sch/Rb1=12.082，且在不同条件下重复性良好；QAMS法的计算结果与外标法的实测值之间无显著性差异，实验所得的f值可信。结论 本实验建立的QAMS法可以作为一种简便准确的质量评价模式用于YFI中多种人参皂苷类成分和Sch的质量控制。

Objective To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of nine components in Yiqi Fumai Injection (YFI). Methods Ginsenoside Rb₁ was used as internal reference substance. The relative correlation factors (f) of ginsenosides Rg₁, Re, Rf, Rc, Ro, Rb₂, Rd, and schisandrin were calculated and established by HPLC. The separation was performed on a Diamonsil^® C₁₈ column (2) (250 mm×4.6 mm, 5 μm), with the mobile phase consisting of acetonitrile and 0.05% phosphoric acid water for gradient elution. The column temperature was 30℃, and the detection wavelength was set at 203 nm, flow rate was 1 mL/min. The results were compared with those obtained by the external standard method in 25 batches of YFI. Results Ginsenosides Rg₁, Re, Rf, Rb₁, Rc, Ro, Rb₂, Rd, and schisandrin had good relations within the ranges of 0.929-4.644, 0.818-4.089, 0.732-3.660, 1.461-7.305, 0.636-3.181, 0.618-3.092, 0.788-3.941, 0.758-3.789, and 0.178-0.889 μg, respectively. The recovery rates were 97.08%-100.94%. The f values of ginsenosides Rg₁, Re, Rf, Rc, Ro, Rb₂, Rd, and schisandrin to ginsenoside Rb₁ were 1.970, 0.929, 1.196, 0.870, 0.830, 0.786, 0.906, and 12.082. The two methods did not show the significant difference in assay results. Conclusion The QAMS method is feasible and credible, and could be used to determine the multiple components in YFI.

重大新药创制科技重大专项（2013ZX09402202）