市售丹参注射液的质量比较研究

Comparative Study on the Quality of Commercially Available Danshen Injection

分别建立高效液相色谱-蒸发光散射检测(HPLC-ELSD)和高效液相色谱-紫外检测(HPLC-UV)法测定市售5个企业共14个批次的丹参注射液中3个糖类成分(D-果糖、D-无水葡萄糖、蔗糖)和6个酚酸类成分(丹参素钠、原儿茶醛、丹酚酸B、迷迭香酸、紫草酸、丹酚酸D)的含量。建立的方法准确简便,明确了丹参注射液总固体中50%左右的物质组成。结果显示,不同企业丹参注射液中的酚酸类成分含量基本一致,糖类成分和总固体含量差异较大,为其进一步质量控制提供了一定的参考。

The HPLC-ELSD and HPLC-UV methods were established to determine the contents of three carbohydrates(D-fructose,D-glucose and sucrose)and six phenolic acids(sodium danshensu,protocatechualdehyde,salvianolic acid B,rosmarinic acid,lithospermic acid and salvianolic acid D)in fourteen batches of Danshen injection from five companies.The established methods were accurate and simple,which clarified the composition of about 50%of total solids of Danshen injection.The results showed that the phenolic acids in Danshen injection from different companies were basically similar in same content,but the carbohydrates and total solid content were quite different,which provided a reference for its further quality control.