论文部分内容阅读
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 C_(18)(2.1 mm×100 mm,1.7μm)色谱柱,以水(A)-乙腈(B)为流动相,梯度洗脱,流速0.5 m L·min~(-1),检测波长203 nm,样品室温度15℃,柱温40℃,进样量10μL。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Rg1:42.52%~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 multi-assessment method (QAMS method) for determining the content of five major saponins in Panax notoginseng saponins R1 and ginsenosides Rg1, Re, Rb1 and Rd in Xueshuantong injection (freeze-dried). Methods: The content of notoginsenoside R1 was determined by UPLC external standard method, then the relative correction factors of this component and ginsenosides Rg1, Re, Rb1 and Rd were calculated, and the content was calculated. The method was verified by method and the external standard method The chromatographic conditions were as follows: BEH C 18 (2.1 mm × 100 mm, 1.7 μm) column, water (A) -acetonitrile (B) as the mobile phase , Gradient elution, flow rate 0.5 m L · min -1, detection wavelength 203 nm, sample chamber temperature 15 ℃, column temperature 40 ℃, injection volume 10μL. Results: The relative calibration factors were of good applicability and reproducibility (RSD <2%). The contents of the six batches of samples were determined by external standard method and one multi - evaluation 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%), t test analysis, p> 0.05, indicating no significant difference. CONCLUSION: The multi-evaluation method established by this study can be used to determine the contents of five major saponins in Xueshuantong (freeze-dried) for injection.