一测多评HPLC法测定丹参注射液中7个水溶性成分含量

目的:建立以原儿茶醛为内参物,同时测定丹参注射液中7个水溶性成分(丹参素钠、原儿茶酸、原儿茶醛、香草酸、阿魏酸、迷迭香酸、丹酚酸B)的一测多评HPLC法,并进行方法学考察。方法:以丹参注射液为研究对象,以原儿茶醛为内参物,确定丹参素钠、原儿茶酸、香草酸、阿魏酸、迷迭香酸、丹酚酸B相对于原儿茶醛的校正因子。采用外标法测定丹参注射液中原儿茶醛的含量,通过相对校正因子对其他6个成分进行定量,并比较该方法与外标法测定结果的差异。结果:各成分相对校正因子重现性良好。丹参素钠、原儿茶酸、香草酸、阿魏酸、迷迭香酸、丹酚酸B按一测多评方法与外标法测定结果无显著差异。结论:本方法简便,测定结果准确,可为全面控制丹参注射液内在质量提供参考。

Objective:To establish a new quantitative method for simultaneous determination of multi-component(sodium danshensu,protocatechuic acid,protocatechuic aldehyde,vanilla acid,ferulic acid,rosmarinic acid,salvianolic acid B) in Danshen injection by using one chemical reference substance,and to validate its feasibilities. Methods:The quantitative analysis of multi-components by single-marker(QAMS) was established and validated with Danshen injection.Seven main ingredients were evaluated and their relative correlation factors(RCFs)were determined by HPLC-UV.The contents of protocatechuic aldehyde in the samples of Danshen injection were calculated by using the external standard method,and the contents of the six other ingredients were calculated by their RCFs.The contents of these six ingredients in all samples were also determined by using the external standard method. Results:The RCFs of sodium danshensu,protocatechuic acid,vanilla acid,ferulic acid,rosmarinic acid and salvianolic acid B all showed good reproducibility within certain ranges.For sodium danshensu,protocatechuic acid,vanilla acid,ferulic acid,rosmarinic acid and salvianolic acid B,there was no significant difference between the quantitative results of the two methods. Conclusions:The method is simple,accurate and suitable to evaluate the contents of seven main water-soluble substances in Danshen injection.