电感耦合等离子体质谱法检测药品中重金属及其他元素的研究进展

Research Progress of Determination of Heavy Metal and Other Elements in Drugs by ICP-MS

重金属及其他元素的含量控制一直是药品生产过程中需要注意的问题,同时也是药品安全的重要问题。采用电感耦合等离子体质谱法(ICP-MS)进行元素分析,操作简单,具有检出限低、线性范围广、能同时测定多种元素、分析快速、准确度高、灵敏度好等优势,适用于药品生产领域。中国加入国际人用药品注册技术协调会(ICH)后,药品中元素限量的控制也要与国际接轨,因此采用有效的检测方法尤其重要。基于此,综述了近年来ICP-MS在中药材、中成药、化学药中重金属及其他元素分析中的应用进展,介绍了药品中重金属及其他元素的源头控制及样品前处理方法,并将ICP-MS在该领域的发展进行了展望(引用文献51篇)。

The content control of heavy metal and other elements had always been a problem that needed attention in the production process of drug,and it was also an important issue of drug safety.Inductively coupled plasma mass spectrometry(ICP-MS)was used for element analysis,the operation was relatively simple,and it had the advantages of low detection limit,wide linear range,simultaneous determination of multiple elements,fast analysis,high accuracy,and good sensitivity.After China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH),the control of element limits in drugs was also be in line with international standards,so it was especially important to adopt effective detection methods.Research progress of determination of heavy metal and other elements in Chinese crude drug,Chinese patent medicines,and chemical medicines in recent years by ICP-MS was reviewed.The source control and sample pretreatment methods of heavy metal and other elements in drugs were introduced,and the development of ICP-MS in this field was prospected(51 ref.cited).