体外人外周血单个核细胞热原检测法用于ACYW135群脑膜炎球菌多糖疫苗的方法学研究  

The suitability of meningococcal groups ACYW135 polysaccharide vaccine for human peripheral blood mononuclear cell(PBMC) in vitro pyrogen test

作　　者：蔡彤[1] 张媛[1] 贺庆[1] 刘倩[1] 杜颖 陈晨[1] 高华[1] 

机构地区：[1]中国食品药品检定研究院药理室,北京100050

出　　处：《科技导报》2017年第17期88-91,共4页Science & Technology Review

基　　金：国家"重大新药创制"科技重大专项(2012ZX09304010)

摘　　要：为考查体外人外周血单个核细胞热原检测法对ACYW135群脑膜炎球菌多糖疫苗的适用性,选取不同厂家共10批供试品,使用体外人外周血单个核细胞热原检测法,采用加样回收干扰实验考察供试品是否存在干扰。结果表明,大部分供试品在最大有效稀释倍数内,IL-6法干扰实验的回收率在50%~200%,且热原物质含量均低于标准限值,均为合格样品。研究表明,体外人外周血单个核细胞热原检测法可用于ACYW135群脑膜炎球菌多糖疫苗热原检测。To investigate the suitability of meningococcal groups ACYW135 polysaccharide vaccines for human peripheral blood mononuclear cell （PBMC） in vitro pyrogen test （IL-6）, 10 batches of vaccines from different manufacturers are collected. The recovery is determinated by human PBMC-IL-6 in vitro pyrogen test with spiking bacterial endotoxin. The recovery of 10 batches of vaccines is between 50%--200%, and the test solutions are at a dilution less than the maximum valid dilution （MVD）. The results show that all the 10 batches of vaccines are qualified products in the pyrogen test. The meningococcal groups ACYW135 polysaccharide vaccine is suitable for the human PBMC- IL-6 in vitro pyrogen test to control the pyrogen.

关 键 词：体外人外周血单个核细胞 热原检测法 ACYW135群脑膜炎球菌多糖疫苗 

分 类 号：R392-33[医药卫生—免疫学]