目的:比较不同厂家丹参注射液的质量,并应用对照品对照和高效液相色谱-质谱联用技术对其主要成分进行定性分析。方法:采用Zorbax Extend C18色谱柱,以乙腈-0.05%三氟乙酸水溶液为流动相梯度洗脱,流速为0.8mL.min-1,检测波长为288nm,测定了18个不同厂家生产的丹参注射液的HPLC-UV指纹图谱以及代表性厂家注射液的HPLC-DAD-MS图谱。结果:18个不同厂家生产的丹参注射液在所含化学成分的数目和含量上差异显著;利用对照品对照和HPLC-DAD-MS技术指认了丹参注射液中的15个酚酸类成分。结论:本方法可用于测定不同来源的丹参注射液的色谱指纹图谱,并为丹参注射液的全面质量评价和生产工艺监控提供了可行的方法。

This paper compared the quality of Danshen injections rolled out from different pharmacies,and identified the key components using HPLC-DAD-MS. 18 Danshen injection samples collected from different pharmacies were analyzed on a Zorbax Extend C18 column, with a gradient of acetonitrile and 0.05% TFA at a flow rate of 0.8 ml·min-1, and detected at 288nm. Meanwhile, a typical injection was analyzed using HPLC-DAD-MS technique. The investigation results suggest that the 18 Danshen injection samples analyzed have a large difference in both quantity and content,regarding the key constituents.15 peaks of salvianolic acids were identified, through comparing with the benchmarks and HPLC-MS analysis. It is concluded that the established HPLC fingerprint process is both reliable and specific, and can be used for the comprehensive quality control of Danshen injections.

教育部长江学者和创新团队奖励计划项目(9852220632112): 基于中药资源的创新药物研究, 负责人: 果德安。