流感病毒裂解疫苗中游离甲醛残留量的不确定度评定  

Evaluation of Uncertainty in the Determination about Free FormaLdehyde in InfLuenza Vaccine(SpLitVirion)

作　　者：冯雪 徐志强 张雪楠 赵琳 裴友财 杨红育 FENG Xue;XU Zhiqiang;ZHANG Xuenan;ZHAO Lin;PEI Youcai;YANG Hongyu(Changchun Institute of Biological Products Co.,Ltd.,Jilin Changchun 130012)

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130012

出　　处：《生物化工》2020年第6期54-57,共4页Biological Chemical Engineering

摘　　要：目的:建立顶空-气相色谱法测定流感病毒裂解疫苗中游离甲醛残留量的不确定度评估方法,分析测量不确定度对不同待测浓度样品的影响。方法:依据不确定度评定的指导性文件,分析测量过程中引入的不确定度来源,合成标准不确定度及获得测量结果的扩展不确定度。结果:待测样品浓度较低时,标准曲线拟合是不确定度的主要来源;随着待测样品浓度的升高,标准曲线拟合引入的不确定度逐渐减小。结论:建议尽量选用不确定度较小的标准溶液,进行多次重复测量,从而提高测量的精密度、准确度。Objective:To establish the uncertainty evaluation method for the determination of free formaldehyde residue in influenza virus split vaccine by headspace gas chromatography,and analyze the influence of measurement uncertainty on samples with different concentrations.Methods:according to the guidance document of uncertainty evaluation,the sources of uncertainty introduced in the measurement process were analyzed,and finally the standard uncertainty and expanded uncertainty of measurement results were synthesized.Results:the main source of uncertainty was standard curve fitting when the sample concentration was low;the uncertainty introduced by standard curve fitting decreased with the increase of sample concentration.Conclusion:it is suggested that the standard solution with less uncertainty should be selected as far as possible to carry out repeated measurement for many times to improve the precision and accuracy of measurement.

关 键 词：不确定度 游离甲醛 流感病毒裂解疫苗 

分 类 号：R392-33[医药卫生—免疫学]