四价流感病毒裂解疫苗血凝素含量检测方法的验证  

Validation of a method for determination of hemagglutinin content in quadrivalent influenza vaccine (split virion) inactivated

作　　者：刘朝阳[1] 周欣[1] 王石磊[1] 吕浩[1] 孟佳帆[1] 马雷钧[1] 程鹏飞[1] 

机构地区：[1]上海生物制品研究所有限责任公司,上海200051

出　　处：《中国生物制品学杂志》2016年第1期61-64,69,共5页Chinese Journal of Biologicals

摘　　要：目的 验证四价流感病毒裂解疫苗[quadrivalent influenza vaccines（split virion）inactivated,QIV]血凝素含量检测方法的可行性。方法 采用传统的单向免疫扩散法（single-radial immunodiffusion,SRID）检测QIVH1N1和H3N2型的血凝素含量,双价抗原参考品SRID法检测两种月型（包括B/Yam和B/Vic）血凝素含量,并对该检测方法进行准确度、精密度、专属性及线性验证。结果 QIV各型的血凝素含量总体回收率为97.8%～107.6%,相对标准偏差（relative standard deviation,R SD）为0.59%~1.83%;试验间和试验内RSD均约5.0%;4个型别血凝素含量在10~50μg/ml范围时,标准曲线呈良好的线性,R 2均大于0.980 0,定量限分别为：H1N1：4.53μg/ml,H3N2：3.83μg/ml,B/Yam：2.89μg/ml,B/Vic：5.60μg/ml;各型别流感裂解疫苗供试品和抗原参考品与对应抗血清参考品出现沉淀环,与非对应抗血清参考品不出现沉淀环。结论 QIV血凝素含量检测法是可行的。Objective To validate the feasibility of a method for determination of hemagglutinin content in quadrivalent influenza vaccine（split virion）inactivated（QIV）. Methods The contents of hemagglutinin of subtypes H1N1 and H3N2 in QIV were determined by routine single-radial immunodiffusion（SRID）test, while those of subtype B（B / Yam and B /Vic） by bivalent antigen reference SRID test. The method was validated for accuracy, precision, specificity and linearity.Results The total recovery rates of hemagglutinin contents of various subtypes were 97. 8% ~ 107. 6%, with relative standard deviations（RSDs）of 0. 59% ~ 1. 83%. Both RSDs in inter- and intra-assays were less than 5. 0%. The standard curve showed good linearity at hemagglutinin contents of four subtypes of 10 ~ 50 μg/ml, with R2 values of more than0. 980 0. The quantitative limits of subtypes H1N1, H3N2, B / Yam and B / Vic were 4. 53, 3. 83, 2. 89 and 5.60 μg/ml respectively. Both vaccine samples and antigen references of various subtypes showed precipitation rings with the corresponding antiserum references, while showed no precipitation rings with non-corresponding antiserum references.Conclusion The method for determination of hemagglutinin content in QIV was feasible.

关 键 词：四价流感病毒裂解疫苗 血凝素 单向免疫扩散法 抗原 参考品 

分 类 号：R373.13[医药卫生—病原生物学] R392.33[医药卫生—基础医学]