铝佐剂含量检测方法的探讨

Investigation on methods for determination of aluminum adjuvant content

从铝佐剂使用原则出发,结合新出台法规对铝佐剂和含铝佐剂疫苗精准质量控制的要求,对目前铝佐剂含量常用检测方法——络合滴定法进行探讨。围绕铝佐剂含量检测灵敏度,在了解国内外各行业铝含量检测研究现状的基础上,将具有代表性的方法进行整理和归纳。系统介绍了分光光度法、色谱法、原子吸收光谱法(atomic absorption spectrophotometry,AAS)和电感耦合等离子体法(inductive coupled plasma emission spectrometry,ICP)等检测方法原理、过程以及应用局限性,并对检测方法的样品前处理条件进行介绍,为根据检测要求和实验条件对疫苗类产品铝含量检测方法的选取提供参考。

Based on the application principle of aluminum adjuvant and the requirement for precise quality control of aluminum adjuvant and vaccines containing aluminum adjuvant,complexometric titration was discussed as the common method for determination of aluminum adjuvant content.Focusing on the“sensitivity of aluminum adjuvant content detection”,the representative methods were summarized based on understanding the research status of aluminum content detection in various industries at home and abroad.The principle,process and application limitation of determination methods such as spectrophotometry,chromatography,atomic absorption spectrophotometry(AAS)and inductive coupled plasma emission spectrometry(ICP)are systematically introduced.In addition,the“sample pretreatment”conditions of the test method are introduced in detail in order to provide reference for the selection of methods for determination of aluminum content in vaccine products according to the test requirements and experimental conditions.