白喉类毒素残余毒性检测新方法的建立Development of a novel method for determination of residual toxicity of diphtheria toxoid
马霄;谭亚军;董国霞;田霖;侯启明;
摘要(Abstract)：
目的建立检测联合疫苗中白喉类毒素残余毒性的新方法,以替代现有的家兔皮肤试验法。方法采用Vero细胞法检测白喉类毒素的残余毒性,对该方法的特异性、灵敏度(最低检测限)和重复性进行验证,并对Vero细胞法与家兔皮肤试验法测定白喉类毒素残余毒性的结果进行比较。结果 Vero细胞可特异性检测白喉类毒素的残余毒力,该方法的最低检出限为10-8 LD50白喉毒素,重复性良好,灵敏度比家兔皮肤试验法高10 000倍。结论 Vero细胞法可用于白喉类毒素残余毒性检查和毒性逆转检查,该方法特异性强,灵敏度高于家兔皮肤试验法,适用于以白喉、破伤风为基础的联合疫苗(DT-based combined vaccines,DT combos)的安全性评价。
关键词(KeyWords)： 白喉类毒素;残余毒性;Vero细胞
基金项目(Foundation):
作者(Authors): 马霄;谭亚军;董国霞;田霖;侯启明;
DOI: 10.13200/j.cnki.cjb.000836
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