不同厂家生产的香丹注射液中丹参色谱指纹图谱的比对研究  

Comparative Study on HPLC Fingerprints of Danshen in Xiangdan Injections from Different Manufacturers

作　　者：徐曼[1] 刘爱华[1] 崔亚君[2] 张金兰[1] 果德安[1] 

机构地区：[1]北京大学药学院天然药物与仿生药物国家重点实验室,北京100083 [2]中国科学院上海生命科学研究院药物研究所上海中药现代化研究中心,上海201203

出　　处：《中国天然药物》2007年第2期120-126,共7页

摘　　要：目的:比较不同厂家香丹注射液的质量,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40个不同厂家生产的香丹注射液的HPLC-UV指纹图谱以及代表性厂家注射液的HPLC-DAD-MS图谱。结果:40个不同厂家生产的香丹注射液在所含丹参酚酸类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技术指认了香丹注射液中的19个丹参酚酸类成分。结论:方法可用于测定不同来源的香丹注射液中丹参的色谱指纹图谱,并为其全面质量评价和生产工艺监控提供可靠依据。AIM： To compare the quality of Xiangdan injections from different manufacturers and identify its main components by HPLC-DAD-MS technique. METHODS： 40 Xiangdan injection samples from different manufacturers were analyzed on a Zorbax Extend C18 column with a gradient of aeetonitrile and 0.05 % TFA at a flow rate of 0.8 mL· min^- 1 and detected at 288 nm. Furthermore, a typical injection sample was analyzed by HPLC-DAD-MS technique. RESULTS： The 40 Xiangdan injection samples from different manufacturers had great differences in the numbers and contents of phenolic acid constituents, by comparison with the reference standards and HPLC-MS analysis, 19 peaks of phenolic acids were designated. CONCLUSION： The established HPLC fingerprint method is reliable and specific, which could be used for the comprehensive quality control of Xiangdan injections.

关 键 词：丹参 香丹注射液 指纹图谱 高效液相色谱-质谱联用 

分 类 号：R917[医药卫生—药物分析学] TQ460.72[医药卫生—药学]