寡核苷酸药物及生物标志物的生物分析研究进展

寡核苷酸药物及生物标志物的生物分析研究进展

毛强,赵春景,钱妍,邹品文,罗文

重庆医科大学第二附属医院药学部,重庆医科大学第二附属医院药学部,重庆医科大学第二附属医院药学部,重庆医科大学第二附属医院药学部,重庆医科大学第二附属医院药学部

收稿日期:2019-05-06 修回日期:2019-05-28 出版日期:2019-08-28 发布日期:2019-08-28

Advances in Bio-analysis of Oligonucleotide Drugs and Biomarkers

Qiang Mao,,, and

The Second Affiliated Hospital of Chongqing Medical University,Department of Pharmacy,,The Second Affiliated Hospital of Chongqing Medical University, Department of Pharmacy,,The Second Affiliated Hospital of Chongqing Medical University, Department of Ph

Received:2019-05-06 Revised:2019-05-28 Online:2019-08-28 Published:2019-08-28

摘要/Abstract

摘要： 寡核苷酸已成为多种疾病诊断和治疗的候选药物。寡核苷酸药物及其代谢物、生物标志物的定性定量分析是药物开发和评估所必需的，良好的分析方法有利于控制药品质量及准确定量药品浓度。本文主要探讨了逆转录-实时荧光定量PCR (RT-qPCR)、液相色谱-荧光(LC-FL)、液相色谱-质谱联用（LC-MS/MS）、液相色谱-高分辨质谱联用（LC-HRMS）在寡核苷酸药物和生物标志物的应用及各自的优缺点，旨在概述目前现有寡核苷酸药物和生物标志物的生物分析方法，以期为从事寡核苷酸诊断和治疗药物的研发、分析人员及企业提供参考，以期提高此类新药或仿制药一致性评价分析的水平。

Abstract: Oligonucleotides have become candidate drugs for diagnosis and treatment of many diseases. The qualitative and quantitative analysis of oligonucleotide drugs， their metabolites and biomarkers are necessary for drug development and assessment. Good analytical methods are helpful to control the quality of drugs and quantify the concentrations of drugs accurately. Thus， the application of quantitative reverse transcription PCR (RT-qPCR)， liquid chromatography-fluorescence (LC-FL)， liquid chromatography-mass spectrometry (LC-MS/MS)， liquid chromatography-high resolution mass spectrometry (LC-HRMS) in the oligonucleotides drugs and biomarkers were discussed in this review， and their advantages and disadvantages were analyzed， respectively. This review aimed to summarize the existing biological analytical methods for oligonucleotide drugs and biomarkers， in order to provide references for the researchers and enterprises who are engaged in the development and assessment of oligonucleotides diagnostic and therapeutic drugs， and to improve the level of consistency evaluation and analysis of new drugs or generic drugs.

毛强,赵春景,钱妍,邹品文,罗文. 寡核苷酸药物及生物标志物的生物分析研究进展[J]. .

Qiang Mao,,, and. Advances in Bio-analysis of Oligonucleotide Drugs and Biomarkers[J]. .

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