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

蔡彤; 张媛; 贺庆; 刘倩; 杜颖; 陈晨; 高华

doi:10.3981/j.issn.1000-7857.2017.17.012

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科技导报 ›› 2017, Vol. 35 ›› Issue (17) : 88-91. DOI: 10.3981/j.issn.1000-7857.2017.17.012

研究论文

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

作者信息 -

中国食品药品检定研究院药理室, 北京 100050

作者简介:

蔡彤,硕士研究生,研究方向为药检药理,电子信箱:teddyct@163.com

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

Author information -

National Institutes for Food and Drug Control, Beijing 100050, China

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。

Abstract

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.

导出引用

蔡彤, 张媛, 贺庆, 刘倩, 杜颖, 陈晨, 高华. 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[J]. 科技导报, 2017, 35(17): 88-91 https://doi.org/10.3981/j.issn.1000-7857.2017.17.012

CAI Tong, ZHANG Yuan, HE Qing, LIU Qian, DU Ying, CHEN Chen, GAO Hua. The suitability of meningococcal groups ACYW135 polysaccharide vaccine for human peripheral blood mononuclear cell (PBMC) in vitro pyrogen test[J]. Science & Technology Review, 2017, 35(17): 88-91 https://doi.org/10.3981/j.issn.1000-7857.2017.17.012

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