张媛;蔡彤;杜颖;吴彦霖;陈晨;高华;

• 1:中国食品药品检定研究院

摘要(Abstract)：

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。

关键词(KeyWords)： 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

Abstract:

Keywords:

基金项目(Foundation): 国家科技重大专项(2012ZX09304010)

作者(Authors): 张媛;蔡彤;杜颖;吴彦霖;陈晨;高华;

DOI: 10.13200/j.cnki.cjb.002285

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