基于一测多评的舒血宁注射液定量测定方法研究

Determination of content of Shuxuening Injection based on 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山柰素、槲皮素、异鼠李素和白果内酯与银杏内酯A、B、C的量,并建立以上实验的方法学考察模式。方法分别以山柰素和白果内酯为内参物,建立舒血宁注射液中这2种成分与槲皮素、异鼠李素和银杏内酯A、B、C间的相对校正因子(fk/s);采用外标法测定舒血宁注射液中山柰素和白果内酯的量,通过fk/s计算输血宁注射液中其他5种成分的量,并将用一测多评法测定的5批舒血宁注射液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,山柰素与槲皮素及异鼠李素的fk/s分别为1.873、0.324,白果内酯与银杏内酯A、B、C的fk/s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检验无显著性差异,实验所得的fk/s可信。结论本实验所建立的fk/s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 establish a quantitative analysis method for determining the contents of artemisinin,quercetin,isorhamnetin,Ginkgo esters,and lactones a,b,c in Shuxuening Injection by using multi-components with a single marker（QAMS）,and set up methodological evaluation model of the above experiment.Methods With artemisinin and Ginkgo esters as indexes,the relative correction factor（f_k/s） between artemisinin and the other two total flavonoids and the f_k/s between Ginkgo esters and lactones a,b,c were established.The contents of artemisinin and Ginkgo esters in Shuxuening Injection were determined by external standard method,the contents of other five components in Shuxuening Injection were calculated by the relative correction factor.The results of the content of five batches of Shuxuening Injection determined by QAMS and tested by external standard method were carried out by t test.Results The f_k/s of quercetin and isorhamnetin with reference to artemisinin were 1.873 and 0.324,the f_k/s of ginkgolide A,B,C with reference to Ginkgo esters were 2.280,1.659,and 1.429.And the repeatability was good under different experimental conditions.There were no significant differences between the calculated value and estimated value on QAMS and external standard method of five batches of Shuxuening Injection,and the results showed that f_k/s was authentic.Conclusion The established correction factor has good repeatability,and could be used for quantitative analysis and quality evaluation of multiple components in Shuxuening Injection.