乙型流感疫苗生产用毒株NYMC BX-51B主要抗原的基因特征及传代稳定性研究  

Genetic characteristics and passage stability of major antigens of strain NYMC BX-51B used for influenza B vaccine

作　　者：刘朝阳[1] 程鹏飞[1] 闫现伟[1] 郁佳俊[1] 毛树宝 

机构地区：[1]上海生物制品研究所有限责任公司质量检定室,200051 [2]上海生物制品研究所有限责任公司生产部,200051

出　　处：《国际生物制品学杂志》2015年第2期58-62,共5页International Journal of Biologicals

摘　　要：目的 了解2013年流感疫苗生产用乙型病毒株NYMC BX-51B主要抗原血凝素（hemagglutinin,HA）和神经氨酸酶（neuraminidase,NA）的基因特征,并研究该疫苗株的传代稳定性.方法 对制备的乙型流感病毒株主种子批、工作种子批及收获液病毒进行全面的生物学特性检定.采用逆转录-PCR法从主种子批、工作种子批及疫苗病毒收获液中扩增HA及NA基因片段,并进行全基因序列测定及分析.对7株不同年份的乙型疫苗株及野毒株的HA氨基酸序列进行比对,绘制氨基酸种系发生树.结果 该毒株主种子批和工作种子批的抗原性与WHO2013年推荐的毒株一致,种子批和收获液病毒的生物学特性均符合我国2010年版药典标准.HA基因序列长度为1 755 bp,编码584个氨基酸;NA基因序列长度为1 401 bp,编码466个氨基酸.各代次流感病毒HA和NA的基因核苷酸和氨基酸序列均相同,与GenBank发布的序列完全一致,同源性为100％.2013年乙型疫苗株的HA氨基酸序列与2010和2012年相比,同源性分别为94.3％和98.4％.结论 2013年乙型流感疫苗株NYMCBX-51B主要抗原基因传代稳定,一般生物学特性符合我国药典要求.2013年疫苗株的HA氨基酸序列与2010年相比进化距离较远.Objective To understand gene characteristics of hemagglutinin （HA） and neuraminidase （NA） of strain NYMC BX-51B used for production of influenza B vaccine in 2013,and study stability of the strain during subculture.Methods The master and working seed lots as well as harvested virus were subjected to overall biological tests.HA and NA genes were amplified by RT-PCR and sequenced.The amino acid sequences of HA from 7 vaccine strains or wild strains in different years were compared and a phylogenetic tree was plotted.Results The antigenicity of master and working seed lots was similar to that of the strain recommended by WHO in 2013,while other biological characteristics complied with the requirements in current Chinese pharmacopoeia.HA gene was 1 755 bp long encoding 584 amino acids and NA gene was 1 401 bp encoding 466 amino acids.HA and NA from different passages had same nucleotide and amino acid sequences,with a homology of 100% to those reported in GenBank.The homology of HA amino acid sequence between 2013 and 2010 vaccine strains was 94.3%,while a homology of 98.4% was found between 2013 and 2012 vaccine strains.Conclusions The genes of major antigens in strain NYMC BX-51B are genetically stable during subculture,and the general biological characteristics meet the requirements in Chinese pharmacopoeia.The evolutionary distance of HA amino acid sequences between 2013 and 2010 vaccine strains is relatively far.

关 键 词：流感疫苗 流感病毒B型 血凝素糖蛋白类 流感病毒 神经氨酸酶 

分 类 号：R373.13[医药卫生—病原生物学]