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[摘要]
目的 基于中药质量标志物(Q-marker)理念,从化学成分的角度对复方丹参滴丸中君药丹参的质量标志物进行研究。方法 采用UPLC法对丹参药材和复方丹参滴丸中主要的丹酚酸类成分进行测定,并模拟复方丹参滴丸提取工艺,对紫草酸和丹酚酸B、E、T、U这5个丹酚酸类成分的转化进行研究。结果 在丹参药材中,主要有2个丹酚酸类成分,即丹酚酸B(占总酚酸比例>90%)和迷迭香酸(>5%);而在复方丹参滴丸中,主要有8个丹酚酸类成分,即丹参素、原儿茶醛、迷迭香酸和丹酚酸A、B、D、T、U,其中丹参素、原儿茶醛含量相对较高。在提取加工中,紫草酸和丹酚酸B、E、T、U能转化生成相对分子质量相对较小的丹酚酸类成分,而丹参素、原儿茶醛是主要的终产物。结论 丹参药材选择丹酚酸B作为水溶性丹酚酸类成分的质量标志物科学合理,而丹参药材在制备复方丹参滴丸的过程中,丹酚酸类成分发生了化学转化,产生了8个主要的丹酚酸类成分,并以其中的丹参素和原儿茶醛的含量最高,又因丹参素具有种属来源特异性,故从化学成分层面上,复方丹参滴丸选择丹参素作为君药丹参的质量标志物科学合理。
[Key word]
[Abstract]
Objective To explore the chemical ingredients of Salvia miltiorrhiza in Compound Danshen Dripping Pills (CDDP) based on the concept of quality marker (Q-marker).Methods The main salvianolic acids of S.miltiorrhiza and CDDP were determined by UPLC method.According to the extraction process of CDDP chemical transformation of salvianolic acids, including lithospermic acid, salvianolic acids B, E, U, and T were studied.Results Salvianolic acid B and rosmarinic acid, more than 90.0% and 5.0% of total salvianolic acid, were the main salvianolic acids in S.miltiorrhiza.But in CDDP, eight salvianolic acids (danshensu, protocatechuic aldehyde, salvianolic acids A, B, D, T, and U) were the main salvianolic acids.And the contents of danshensu and protocatechuic aldehyde were higher than the other six salvianolic acids.Through the study on chemical transformation of salvianolic acids, it was proved that lithospermic acid, salvianolic acids B, E, U, and T could transform into other salvianolic acids with smaller molecular weight, and danshensu and protocatechuic aldehyde were the main end products.Conclusion It is scientific to choose salvianolic acid B as the Q-marker of salvianolic acids of S.miltiorrhiza, and danshensu as the primary Q-marker.During the preparation of CDDP, salvianolic acids from S.miltiorrhiza have chemical chages, eight main salvianolic acids of which have been produced.The contens of danshensu and protocatechuic aldehyde are the highest in the eight salvianolic acids.From the chemical composition level, it is scientific and reasonable to choose danshensu as the Q-marker of monarch herb S.miltiorrhiza in CDDP.
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[基金项目]
国家“重大新药创制”科技重大专项(2013ZX09402202)