寡核苷酸作为治疗药物在抗肿瘤、病毒治疗、免疫调节等方面有着良好的应用前景。寡核苷酸药物的药代动力学的研究和质量控制均要求具备相应的定量分析方法。本文综述了近年来在寡核苷酸药物药代动力学评价及生产质量控制中常用的几种定量分析方法,主要包括质谱法、毛细管电泳法、定量PCR法以及杂交技术相关的方法,阐述了各方法的特点、应用前景及其最新研究进展。
As therapeutic drugs,oligonucleotides have shown promising perspective in the treatment of cancer,viral infection and immuno-regulation.The advenced bioanalytical techniques for quantitation of oligonucleotides are required in the process of pharmacokinetics study and quality control.The development and recent advances of most common quantitative techniques includeing mass spectrometry(MS),capillary electrophoresis(CE),quantitative polymerase chain reaction(qPCR),hybridization technique are reviewed in this paper.Method's features,application prospects,and technical limitations are also discussed.