液质联用技术在药品质量分析中的应用进展  

The Application Progress of Liquid Chromatography Tandem Mass Spectrometry in Drug Quality Analysis

作　　者：张杰 赵文法 王春雷 冯家龙 李培 胡雨生 Zhang Jie;Zhao Wenfa;Wang Chunlei;Feng Jialong;Li Pei;Hu Yusheng(Liaocheng Inspection and Examination Center,Liaocheng 252000,China)

机构地区：[1]聊城市检验检测中心,山东聊城252000

出　　处：《山东化工》2023年第16期118-123,共6页Shandong Chemical Industry

摘　　要：药品是一类特殊的商品,具有预防治疗疾病和引起不良反应两方面的特点,当下药品种类繁多,市面上的药品鱼目混杂,开展药品质量分析,有效地对药品实行监督抽检、对制药流程、体内代谢、违法添加等行为进行动态管控显得尤为重要。伴随着新技术的研发,液相色谱质谱联用技术(LC-MS/MS)因具有分析速度快、分离效能高、高特异性和高灵敏度等特点被广泛地应用到新药研发、药品复杂成分鉴定和代谢产物分析等领域。文章从介绍LC-MS/MS的基本原理入手,依次介绍了LC-MS/MS技术在药品含量测定、中药活性成分分析、药品有关物质分析、农药残留检测、非法添加物质分析、药物代谢动力学和药物代谢组学七个方面的研究进展,分析LC-MS/MS技术在各方面的优势特点和不足,并预测其未来的研究发展方向,文章可以为药品检测和研发人员选择合适的检测手段提供参考,也可以为药品监管部门提供技术和理论支持。Drugs are a kind of special commodities which can prevent and treat diseases and cause adverse reactions.At present,there are a wide variety of drugs and the quality of the drugs varies considerably on the market.Therefore,it is particularly important to carry out drug quality analysis,to supervise and spot check of drugs,and to carry out dynamic control of pharmaceutical process,internal metabolism,illegal addition and other behaviors.With the development of new technology,liquid chromatography-tandem mass spectrometry(LC-MS/MS)has been widely used in the fields of new drug research and development,identification of drug complex components and analysis of metabolites due to its characteristics of fast analysis speed,high separation efficiency,high specificity and high sensitivity.This paper started with the introduction of the basic principle of LC-MS/MS,reviewed the research progress of LC-MS/MS technology in seven aspects:drug content determination,analysis of the active ingredients of traditional Chinese medicine,analysis of drug related substances,detection of pesticide residues,analysis of illegal additive substances,pharmacokinetics and pharmacometabolomics,analyzed the advantages and shortcomings of LC-MS/MS technology and predicted its future research and development direction.This paper can provide reference for drug testing and scientific research personnel to choose appropriate testing means,and also provide technical and theoretical support for drug regulatory departments.

关 键 词：液质联用技术 药品质量 药品有关物质 农药残留 非法添加 药物代谢动力学 药物代谢组学 

分 类 号：TQ460[化学工程—制药化工]