人新鲜全血体外热原检测方法对两种疫苗适用性的评价  

Suitability of human whole blood in vitro pyrogen test to two vaccines

作　　者：张媛[1] 蔡彤[1] 杜颖 吴彦霖[1] 陈晨[1] 高华[1] ZHANG Yuan;CAI Tong;DU Ying;WU Yan-lin;CHEN Chen;GAO Hua(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国生物制品学杂志》2018年第9期995-998,共4页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2012ZX09304010)

摘　　要：目的评价人新鲜全血体外热原检测方法对23价肺炎球菌多糖疫苗和双价肾综合征出血热灭活疫苗的适用性。方法分别选取不同厂家的10批23价肺炎球菌多糖疫苗和9批双价肾综合征出血热灭活疫苗,以白介素-1β(interleukin-1β,IL-1β)及IL-6为检测指标,采用加样回收干扰试验考察供试品对人新鲜全血体外热原检测法是否存在干扰,同时采用细菌内毒素动态显色测定法检测供试品,比较两种方法的检测结果。结果两种疫苗在最大有效稀释倍数内,干扰试验的回收率均在50%~200%,且热原物质含量均低于标准限值,均为合格样品,与细菌内毒素动态显色测定法结果一致。结论以IL-1β及IL-6为检测指标的人新鲜全血体外热原检测方法适用于两种疫苗。Objective To investigate the suitability of human whole blood in vitro pyrogen test to 23-valent pneumococcal polysaccharide vaccine and bivalent haemorrhagic fever with renal syndrome vaccine,inactivated. Methods Ten batches of 23-valent pneumococcal polysaccharide vaccine and nine batches of bivalent haemorrhagic fever with renal syndrome vaccine,inactivated from various manufacturers were collected and subjected to spike recovery interference test using interleukin-1β（IL-1β） and IL-6 as indicators to investigate whether the samples interfere in the human whole blood in vitro pyrogen test. Meanwhile,the samples were determined for bacterial endotoxin by dynamic chromogenic method,and the results were compared with those by human whole blood in vitro pyrogen test. Results The recoveries of two vaccines were 50% ~ 200% at a dilution less than the maximum valid dilution（MVD）,and the pyrogen contents were less than the limit in relevant standard,which were consistent with the results of bacterial endotoxin test. Conclusion The human whole blood in vitro pyrogen test is suitable for control of pyrogen in 23-valent pneumococcal polysaccharide vaccine and bivalent haemorrhagic fever with renal syndrome vaccine,inactivated.

关 键 词：23价肺炎球菌多糖疫苗 双价肾综合征出血热灭活疫苗 热原 人新鲜全血 白介素 

分 类 号：R373.23[医药卫生—病原生物学] Q75[医药卫生—基础医学]