HPLC法测定流感疫苗中痕量甲醛的不确定度评定  

Evaluation of uncertainty of HPLC in measurement of trace formaldehyde content in influenza vaccine

作　　者：李井涛 谷丽娟 李天雨 王佳凤 

机构地区：[1]吉林省食品检验所,吉林长春130103 [2]长春生物制品研究所有限责任公司,吉林长春130062 [3]吉林省安信食品技术服务有限责任公司,吉林长春130021

出　　处：《中国生物制品学杂志》2017年第11期1215-1219,共5页Chinese Journal of Biologicals

摘　　要：目的对HPLC法测定流感疫苗中游离甲醛残留量的不确定度进行评定。方法通过分析测量过程,确定并简化不确定度来源,经统计学方法,量化不确定度分量,计算合成不确定度和扩展不确定度。结果 HPLC法测定流感疫苗中游离甲醛残留量和不确定度结果可表示为(8.04±0.24)μg/ml,k=2。结论该方法适用于流感疫苗中游离甲醛残留量的不确定度评定,可为测定游离甲醛残留量提供依据。Objective To evaluate the uncertainty of HPLC in measurement of trace formaldehyde content in influenza vaccine. Methods The source of uncertainty was determined and simplified by analysis the process of measurement, and quantized by statistical analysis, based on which the combined standard uncertainty and expanded standard uncertainty were calculated. Results The expanded standard uncertainty of HPLC in measurement of trace formaldehyde content in influenza vaccine was（8. 04 ± 0. 24） μg/ml, k = 2. Conclusion The method was applicable for the uncertainty evaluation of measurement of trace formaldehyde content in influenza vaccine, which provided a basis for determination of residual content of free formaldehyde.

关 键 词：流感疫苗 高效液相色谱 甲醛 不确定度 

分 类 号：R373.13[医药卫生—病原生物学] O657.72[医药卫生—基础医学]