一测多评法同时测定舒血宁注射液中4种内酯含量

Simultaneous determination of four lactones ingredients content in Shuxuening injection by quantitative analysis of multi-components by single marker

目的采用"一测多评"法同时测定舒血宁注射液中4种内酯成分(白果内酯与银杏内酯A、B、C)的含量,并考察其方法学。方法以白果内酯为内参物,建立舒血宁注射液中白果内酯与银杏内酯A、B、C间的相对校正因子;采用外标法测定舒血宁注射液中白果内酯的含量,通过相对校正因子计算舒血宁注射液中银杏内酯A、B、C的含量,并将用"一测多评"法测定的5批舒血宁注射液含量的结果与用外标法测定的结果进行t检验。结果在一定的线性范围内,白果内酯与银杏内酯A、B、C的相对校正因子分别为:2.280、1.659、1.429,且在不同的实验条件下重现性良好;5批舒血宁注射液的"一测多评"法计算值与外标法测定值经t检验,差异无统计学意义;实验所得的校正因子可信。结论本实验所建立的校正因子重复性良好,可用于舒血宁注射液中多个成分的定量分析与质量评价。

Objective To simultaneous determine four lactones（ bilobalide and ginkgolides A,B and C） ingredients content in Shuxuening injection by quantitative analysis of multi-components by single marker（ QAMS）,and evaluation the methodological. Methods With Ginkgo esters as the indexes,the relative correction factor（ RCFs） between bilobalide and ginkgolides A,B,C were established. The content of bilobalide in Shuxuening injection were determined by external standard method,the content of ginkgolides A,B,C in Shuxuening injection was calculated by the relative correction factor. The results of the content of 5 batches of Shuxuening injection determined by QAMS and tested by external standard method were carried out by t test. Results The RCFs of ginkgolides A,B,C with reference to bilobalide were 2. 280,1. 659 and 1. 429. And the repeatability was good under different experimental conditions. There was no significant differences between the calculated value and estimated value on QAMS and external standard method of the 5 batches of Shuxuening injection,the results showed that the RCF was authentic. Conclusion The established correction factor is good repeatability,and could be used for quantitative analysis and quality evaluation of multiple components in Shuxuening injection.