生物样品分析中基质效应和准确度的确定

摘要

In the analysis of biological samples, on top of the high activity and lability of the analytes, so-called matrix effect greatly aggravates the complexity and difficulty of the analyses. At the moment, the only way to help to verify the accuracy of this kind of measurements is the test of standard addition recovery. Without accuracy, all the measurements are meaningless. However, many authors have not paid due attention to the problems concerning accuracy. In this paper, a number of guidelines published by international authorities, as well as the latest text books on pharmaceutical analysis are cited to elucidate the issues on accuracy. It is pointed out that, in the study of pharmacokinetics, the method of standard addition can be used to verify the accuracy of the measurement of the drugs contained in the serum, whether the data is valid depends on the results of the recovery measurement; however, in the study of medicine distribution in the biological organs, even the method of standard addition does not ascertain the accuracy of the measurements.%在生物样品分析中,除了被分析药物本身高活性和高度不稳定性等因素造成的问题之外,生物样品中基质效应的存在也会使生物样品分析的复杂性和难度加大.目前人们通常采用加样回收的方法考察生物样品分析方法的准确度.如果分析方法准确度不合格,所得到的数据也是无意义的,但一些作者并没有充分认识到准确度的重要性.本文主要通过引用国际权威机构的分析方法验证指南以及国内最新版药物分析教科书中有关内容对准确度进行阐述.值得注意的是,在药代动力学研究中,血清中药物测定数据的准确性以及是否可用取决于回收率结果是否合乎要求,但关于药物在生物体内的分布问题上,即使采用加样回收方法也不一定能保证数据是准确的.