摘要
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 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 ×100mm,1.7μm ） column was used, the mobile phase consisted of water （ A ） -acetonitrile （ B ） with gradient elution at a flow rate of 0.5 mL＂ rain-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 and QAMS method by t-test （p〉0.05）. Conclusion： The QAMS method established can be used for quality control of Xueshuantong for injection （ lyophilization ）.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2017年第6期975-981,共7页
Chinese Journal of Pharmaceutical Analysis
