新一代测序技术进展及其在药品质量控制中应用和发展趋势  

Progress of next generation sequencing technology and its application and development trend in drug quality control

作　　者：张国林 景荣先[2] 刘昆梅[3] 周琴[2] 郭乐[3] 邢以文 薛满 ZHANG Guo-lin;JING Rong-xian;LIU Kun-mei;ZHOU Qin;GUO Le;XING Yi-wen;XUE Man(Suzhou Institute for Drug Control,Suzhou 215104,China;Suzhou Municipal Hospital,Suzhou 215000,China;Ningxia Medical University,Yinchuan 750004,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215104 [2]苏州市立医院,苏州215000 [3]宁夏医科大学,银川750004

出　　处：《药物分析杂志》2021年第1期1-12,共12页Chinese Journal of Pharmaceutical Analysis

基　　金：苏州市科技发展计划项目(SYS2020199,SYS201425);江苏省市场监督管理局科技项目(KJ207561)。

摘　　要：基因测序技术的发明和广泛应用促进了医学和生命科学的革命性发展。自以Sanger测序法和化学降解法为代表的第1代测序技术发明以来,基因测序技术已发展至第4代。第1代测序平台主要为Sanger测序法和化学降解法,测序长度长,准确性高,但成本高,通量低和耗时长;第2代测序平台主要有454/GS-FLX测序平台、SOLID测序平台、Solexa测序平台和HiSeq/MiSeq测序平台及HeliScope测序平台;以单分子测序技术为基础的第3代测序平台基于单分子水平的边合成、边测序而无需PCR扩增,主要包括HeliScope测序平台和SMRT测序平台;ONT纳米孔单分子测序技术是基于电信号而非光信号的测序技术,具有高通量、低成本、耗时短和数据分析相对简单的优点,通常归为第4代测序平台。测序技术在药品洁净环境控制和中药质量分析方面有着越来越广泛的应用。随着测序技术的进步和生物信息学的发展,测序技术在医学和生命科学中的应用将发挥更大的作用。Innovation and wide application of gene sequencing technology have significantly promoted the development of medicine and life science.Since Sanger sequencing and chemical degradation were invented as the first generation sequencing technology,gene sequencing technology has been developed into the fourth generation in the past 40 years.The first generation sequencing was based on Sanger sequencing and Maxam-Gilbert method.These methods showed long sequencing length and high accuracy,but with high cost,low throughput and long sequencing time.The main platforms of the second generation sequencing included 454/GS-FLX,SOLID,Solexa,Hiseq/Miseq,and Heliscope platforms.The third generation sequencing platform was based on single molecule level side synthesis and side sequencing without PCR amplification,mainly including Heliscope platform and SMRT platform.ONT nanopore single molecule sequencing technology was based on electrical signal rather than optical signal.This method had the advantages of high throughput,low cost,short time and relatively simple data analysis,which was usually classified as the fourth generation sequencing platform.Sequencing technology is widely used in environment control of drug and quality analysis of traditional Chinese medicine.With the development of sequencing technology and bioinformatics,the application of sequencing technology in medicine and life science will play a more significant role.

关 键 词：核酸测序技术 测序平台 药品质量保障 电信号 单分子测序 高通量 光信号 

分 类 号：R917[医药卫生—药物分析学]