生物分析中溶血对检测的影响及其对策  

Impact of hemolysis on detection in bioanalysis and its countermeasures

作　　者：刘小娟[1] 杜晓琳[1] 黄娟[1] 雍小兰[1] 

机构地区：[1]中国人民解放军成都军区总医院临床药学科,四川成都610083

出　　处：《中国新药与临床杂志》2017年第4期181-185,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：液相色谱-串联质谱(LC-MS/MS)技术灵敏度高,选择性强,是目前体内药物分析的首选方法 ,但LC-MS/MS生物分析中仍面临着溶血样品测定失败的难题。溶血导致的样品测定数据不准确,将直接影响药物的药动学研究,如何进行溶血样品的测定已成为各国监管机构和全球生物分析行业探讨的重点。本文从溶血样品产生的原因进行分析,将溶血对检测的影响和作用方式以及溶血效应的考察方法进行了概述,最后对溶血样品的测定方法和策略进行探讨。Liquid chromatography-mass spectrometry （LC- MS/MS） has advantages of high sensitivity and specificity. It becomes the first choice for drug analysis in vivo. However, there is still a difficult problem with the detection of hemolyzed samples in LC- MS/MS bioanalysis. Hemolysis may lead to inaccurate sample data, which will directly affect the pharmacokinetics study of the drugs. How to determine hemolyzed samples has become the focus of various regulatory agencies and biological analysis industry worldwide. In this paper, the cause of hemolyzed samples, the impact of hemolysis on detection and the way of action, as well as the methods of hemolysis effect test were summarized. Finally, the methods and strategies for the determination of hemolyzed samples were discussed.

关 键 词：溶血 生物分析 串联质谱 色谱法 高压液相 

分 类 号：R917[医药卫生—药物分析学]