丹参类注射剂中主要成分含量的比较分析

目的:测定目前常见丹参类注射剂品种中主要化学成分的含量并比较其差异。方法:采用超高效液相色谱(UPLC)法同时测定8个厂家生产的6种丹参类注射剂(丹参注射液、注射用丹参(冻干)、注射用丹参多酚酸盐、香丹注射液、丹红注射液、丹香冠心注射液)中6种主要化学成分(丹参素、原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B和丹酚酸A)的含量;比较其主要化学成分的差异。结果:不同品种丹参类注射剂的成分种类及含量差异很大;不同厂家生产的同一类丹参类注射剂化学成分含量差异很大。结论:本方法准确、快速,可用于丹参类注射剂中上述6种成分的含量测定;各种丹参类注射剂化学成分含量差异显著,临床应用时各品种不能随意替换;部分丹参类注射剂品种的生产工艺和质量标准亟待提高。

Comparative Analysis on the Major Constituents in Radix Salviae Miltiorrhizae Injectable Preparations

OBJECTIVE： To determine and compare the major constituents in common Radix Salviae Miltiorrhizae injectable preparations.METHODS： UPLC method was applied for simultaneously determination of six major constituents （tanshinol, protocatechuic aldehyde, eaffeic acid, rosmarinei acid, salvianolic acid B and salvianolic acid A） in six Radix Salviae Miltiorrhizae injectable.preparations（Radix Salviae Miltiorrhizae injection,Radix Salviae Miltiorrhizae for injection（freeze drying） ,Radix Salviae Miltiorrhizae polyphenol hydrochloride for injection,Xiangdan injection,Danhong injection,Dangui guanxin injection） from 8 manufacturers.Their differences in the major chemical composition were compared. RESULTS： There were great difference among these Radix Salviae Miltiorrhizae injectable preparations in constituents and the contents. The contents of chemical constituents were also greatly different among the same kind of preparations produced by different manufacturers. CONCLUSION：This method is accurate and rapid and can be used for the content determination of the 6 constituents in Radix Salviae Miltiorrhizae injectable preparations. Because the contents of chemical constituents are strikingly different among these kinds of preparations, various preparations cannot be randomly replaced by each other in clinical use. The preparation technology and quality standard for some Radix Salviae Miltiorrhizae injectable preparations remain to be improved.