生物样品中多肽药物质谱定量分析方法研究进展

Progress of analytical methods for mass spectrometric quantification of polypeptide drugs in biological specimens

质谱(MS)在药代研究中起非常重要的作用。液质联用技术,由于其特异性好和灵敏度高,被认为是生物样品定性和定量的最有效分析手段。药物研究领域正在开发能够对肽类药物进行绝对定量分析的新技术方法。基于多肽药物的结构及理化性质,本文综述了利用LC-ESI-MS技术对生物基质中多肽药物进行定量分析的特点与难点,重点讨论在药物定量分析中的多种样品处理技术、多肽色谱分离、ESI-MS的重要特点、质谱检测模式的选择、内标的选择以及现代质谱技术等。

On the basis of comprehensive experience in the analysis of small drug molecules, pharmaceutical research is one of the developing technologies for analysis of a growing number of peptide drug candidates. The pharmaceutical application of several technologies to sample preparation, various aspects of peptide chromatography, important characteristics of ESI-MS, selectivity of MS-detection modes, the large variability of internal standards, and modern instrumentation are discussed in this review.