吸附无细胞百白破联合疫苗中硫柳汞含量测定的不确定度评定  

Evaluation of uncertainty in the determination of thiomersal content in Adsorbed Diphtheria,Tetanus,and Acellular Pertussis Combined Vaccine

作　　者：王玮 杨雁霞 罗文君 王永蓉 WANG Wei;YANG Yan-Xia;LUO Wen-Jun;WANG Yong-Rong(Yunnan Provincial Institute for Food and Drug Control,MIIT Public Service Platform for Industrial Technology Foundation,Kunming 650101,China;Yunnan Corps Comprehensive Information Security Center,Kunming 650000,China)

机构地区：[1]云南省食品药品监督检验研究院,工业和信息化部产业技术基础公共服务平台,昆明650101 [2]云南总队综合信息保障中心,昆明650000

出　　处：《实验室检测》2024年第11期161-163,共3页Laboratory Testing

摘　　要：目的建立滴定法测定吸附无细胞百白破疫苗硫柳汞含量不确定度评定方法,发现引起较大不确定度的来源,提高实验室检测能力。方法采用2020年版《中华人民共和国药典》通则3115第一法滴定法,建立数学模型分析检测过程中不确定度的来源,并合成标准不确定度及扩展不确定度。结果在影响硫柳汞含量测定中,各影响因素均有一定的作用,经A类评定和B类评定,求得扩展不确定度U_(rel)(含量)=4.72%(K=2)。结论经对各因素引入的不确定度评定发现,引入较大不确定度的因素主要是供试品的滴定过程,可在后续方法改进中考虑滴定过程处在低温等条件下。Objective To establish a titration method for evaluating the uncertainty in the determination of thiomersal content in adsorbed diphtheria,tetanus,and acellular pertussis combined vaccine,and to identify the sources of significant uncertainty,improve laboratory detection ability.Methods The titration method was established according to the first method of the General Rules 3115 in the 2020 edition of the Pharmacopoeia of the People’s Republic of China,a mathematical model was established,and the sources of uncertainty in the detection process were analyzed to synthesize the standard uncertainty and extended uncertainty.Results In the determination of thiomersal content,all influencing factors have a certain effect.After type A evaluation and type B evaluation,the extended uncertainty U_(rel)=4.72%(K=2)was obtained.Conclusion After evaluating the uncertainty introduced by each factor,it was found that the factors introducing significant uncertainty are mainly the titration process of the test sample.It is suggested that the titration process in low-temperature and other conditions be considered in subsequent method improvements.

关 键 词：吸附无细胞百白破联合疫苗 硫柳汞含量测定 滴定法 不确定度 

分 类 号：TQ460.72[医药卫生—药物分析学]