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目的:建立以丹参素钠为内参物,一测多评法同时测定丹参合剂中5种水溶性成分(丹参素钠、原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B)的含量。方法:以丹参合剂为研究对象,以丹参素钠为内参物,确定原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B相对于丹参素钠的相对校正因子。外标法测定丹参素的含量,通过相对校正因子对其他4个成分进行定量分析,并比较两法测定结果的差异。结果:各成分相对校正因子重现性良好。原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B一测多评法与外标法测定结果无显著差异。结论:建立的一测多评法表明具有了良好的重现性,可用于丹参合剂中水溶性成分的质量评价。
OBJECTIVE: To establish a method for simultaneous determination of five water-soluble constituents (sodium danshensu, protocatechuic aldehyde, caffeic acid, rosmarinic acid and salvianolic acid B) content. Methods: Taking Danshen mixture as research object and sodium danshensu as internal reference substance, the relative correction factors of protocatechuic aldehyde, caffeic acid, rosmarinic acid and salvianolic acid B to sodium danshensu were determined. The external standard method was used to determine the content of Danshensu, and the other four components were quantitatively analyzed by relative correction factors. The difference between the two methods was also compared. Results: The relative correction factor of each component has good reproducibility. Protocatechuic aldehyde, caffeic acid, rosmarinic acid, salvianolic acid B multiple test method and external standard test results were not significantly different. Conclusion: The established multi-evaluation test shows that it has good reproducibility and can be used to evaluate the quality of water-soluble components in Danshen mixture.