ICP-MS与ICP-OES法测定疫苗中铝含量的比较  

Comparison of ICP-MS and ICP-OES for determination of aluminum in vaccine

作　　者：刘丛丛[1] 林元亨 尹燕香 梁蔚阳[1] 吴伟平 LIU Congcong;LIN Yuanheng;YIN Yanxiang;LIANG Weiyang;WU Weiping(Guangdong Institute for Drug Control,Guangdong Drug Administration Key Laboratory of Quality Control and Research of Blood Products,NMPA Key Laboratory of Quality Control of Blood Product,Guangdong 510663,China)

机构地区：[1]广东省药品检验所,广东省药品监督管理局血液制品质量控制研究重点实验室,国家药品监督管理局血液制品质量控制重点实验室,广州510663

出　　处：《中国药品标准》2024年第5期471-477,共7页Drug Standards of China

基　　金：广东省医学科学技术研究基金项目(B2022321、B2023318、B2023363);广东省药品监督管理局科技创新项目(2023ZDZ02、2023YDZ02、2023YDZ04)。

摘　　要：目的:比较电感耦合等离子体质谱法(ICP-MS)与电感耦合等离子体发射光谱法(ICP-OES)和《中国药典》2020年版滴定法用于含铝佐剂疫苗中铝含量的测定。方法:通过方法学验证和样品测定,对比分析两种方法的前处理方法、线性、重复性、准确度、定量限、检测限和样品测定结果,同时采用现行版《中国药典》收载的滴定法对典型样品进行检测,并对三种方法的分析条件和结果进行了对比。结果:ICP-OES的铝离子浓度在1~20μg·mL^(-1)线性关系良好,r为0.9999,6种疫苗中铝含量回收率在99%~104.6%范围内,RSD均低于3%(n=9);ICP-MS测得的铝离子浓度在2.5~80 ng·mL^(-1)线性关系良好,r为0.999,6种疫苗中铝含量回收率在99.4%~108.9%范围内,RSD均低于8%(n=9)。三种方法测得的铝含量结果略有差异,但未发现显著规律,相对偏差均小于10%,ICP-MS法、ICP-OES法及滴定法对疫苗中铝含量的检测结果基本一致。结论:ICP-MS和ICP-OES 2种方法均可用于含铝佐剂疫苗中铝离子含量的测定,两种检测方法简便、快速、准确。ICP-OES仪器成本较低,更易于实验室推广。Objective:To compare the test methods for aluminum content determination in vaccines by inductively coupled plasma-mass spectrometry(ICP-MS),inductively coupled plasma optical emission spectrometry(ICP-OES)and titration of the Chinese Pharmacopoeia 2020.Methods:The pre-treatment procedures,linearity,repeatability,accuracy,quantification limit,detection limit and sample determination results of the three methods were compared and analyzed by methodological verification and sample testing.Results:There was a good linear relationship of ICP-OES in the concentration range of 1-20μg·mL^(-1)aluminum content,r=0.9999.Aluminum content in 6 types of vaccines was in the range of 99%-104.6%,and RSDs were lower than 3%(n=9).There was a good linear relationship of ICP-MS in the concentration range of 2.5-80ng·mL^(-1)(r=0.999).Aluminum content in 6 types of vaccines were in the range of 99.4%-108.9%,and RSDs were lower than 8%(n=9).There was no significant difference between the three methods in the determination of aluminum content in vaccines,and RSDs were lower than 10%.Conclusion:Both ICP-MS and ICP-OES methods can be used for the determination of aluminum content in aluminum adjuvant vaccine.Both detection methods are simple,fast and accurate.ICP-OES has lower instrument costs and is easier to promote in the laboratory.

关 键 词：电感耦合等离子体质谱法 电感耦合等离子体发射光谱法 铝 疫苗 佐剂 定量分析 

分 类 号：R921.2[医药卫生—药学]