摘要
药品杂质研究是保证药品质量、安全性的一项关键环节,杂质含量的高低关系着药品质量水平的好坏。当下,药品安全仍然是人们十分关注的公共卫生问题,因此采用高效、准确的检测技术对药品杂质进行系统性分析,可以进一步确保药品的质量安全,为人民群众的健康安全保驾护航。本文结合液相色谱-四级杆/静电场轨道阱高分辨质谱技术(Liquid Chromatography-Quadrupole-Electrostatic Field Orbitrap High Resolution Mass Spectrometry,LC-Q-Orbitrap HRMS)的相关原理,阐明LC-Q-Orbitrap HRMS技术具有高分辨率和高灵敏度的特点。依据LC-Q-Orbitrap HRMS技术优势,介绍LC-Q-Orbitrap HRMS技术在药品杂质研究中的应用,有效解决传统分析方法在杂质检测中所存在的灵敏度不足、选择性差等问题。并重点介绍该技术应用于基因毒性杂质研究方面的进展,实现药品杂质研究的高通量、非靶向快速筛查和结构鉴定,为药品质量控制和安全性评价提供有力的技术支撑,为有关研究学者和监管部门采用准确的检测技术和手段提供理论基础和现实依据。
The study of drug impurities is a key link in ensuring the quality and safety of drugs,and the level of impurity content is related to the quality level of drugs.At present,drug safety is stll a public health issue of great concern to people.Therefore,using efficient and accurate detection techniques to systematically analyze drug impurities can further ensure the quality and safety of drugs and safeguard the health and safety of the people.This article combines the relevant principles of Liquid Chromatography Quaternary Electron Field Orbitrap High Resolution Mass Spectrometry(LC-Q-Orbitrap HRMS)to elucidate the high resolution and sensitivity characteristics of LC-Q-Orbitrap HRMS technology.Based on the advantages of LC-Q-Orbitrap HRMS technology,this article introduces the application of LC-Q-Orbitrap HRMS technology in the study of drug impurities,effectively solving the problems of insufficient sensitivity and poor selectivity of traditional analytical methods in impurity detection.And focus on introducing the progress of this technology in the research of genotoxic impurities,achieving high-throughput,Non-targeted rapid screening and structural identification of drug impurities,providing strong technical support for drug quality control and safety evaluation,and providing theoretical basis and practical basis for relevant researchers and regulatory authorities to adopt accurate detection techniques and methods.
作者
莫丽娟
于姝燕
郭慧卿
李君
张谦
王国英
陈建平
周刚
MO Li-juan;YU Shu-yan;GUO Hui-qing;LI Jun;ZHANG Qian;WANG Guo-ying;CHEN Jian-ping;ZHOU Gang(School of Pharmacy,Inner Mongolia Medical University,Inner Mongolia,Hohhot 010110,China;Institute for Inner Mongolia Drug Testing,Inner Mongolia,Hohhot 010020,China;The Inner Mongolia Drug Control Center,Inner Mongolia,Hohhot 010020,China)
出处
《化学研究与应用》
北大核心
2025年第9期2518-2527,共10页
Chemical Research and Application
基金
国家药典委员会标准提高项目(BZ2023H024)资助
内蒙古医科大学“教学名师”建设项目(NYJXMS202401)资助
内蒙古自治区高等学校“青年科技英才支持计划”项目资助。
关键词
液相色谱
高分辨质谱
杂质
基因毒性杂质
快速筛查
liquid chromatography
high resolution mass spectrometry
impurities
genotoxic impurities
non-targeted rapid screening
作者简介
通讯作者:陈建平(1980-),男,教授,主要从事中蒙药药效物质基础及质量控制。E-mail:jianping5817@163.com;通讯作者:周刚(1980-),男,主任药师,主要从事药品质量控制。E-mail:gangzhou412@126.com。
