双抗夹心ELISA法在无细胞百日咳疫苗生产质控中的应用  

Monitoring the process optimization of an acellular pertussis vaccine by a sandwich ELISA

作　　者：陈静[1] 蒋强华 熊小培[1] 杜萍[1] 盛兰[1] 项美娟[1] 杨邦玲[1] 

机构地区：[1]武汉生物制品研究所,武汉430060

出　　处：《微生物学免疫学进展》2010年第1期60-62,共3页Progress In Microbiology and Immunology

基　　金：国家科技支撑计划<扩大免疫规划疫苗规模化生产和升级换代关键技术研究>(项目编号2008BAI66B00:)组成项目;课题编号为2008BAI66B04

摘　　要：实验中对无细胞百日咳疫苗的脱毒工序优化后,采用双抗夹心ELISA法来检测百日咳有效组分含量,同时采用效价试验方法来验证结果。ELISA法定量测定有效成分的结果和效价试验结果均证明达到《中国药典》三部2005版的要求。由于双抗夹心ELISA法特异性强,灵敏度高,适用于无细胞百日咳疫苗生产各个环节的质量控制。After optimizing the process of acellular pertussis vaccine（APV）,Two Sandwish ELISA methods were used to detect the effective component content of APV.The results of ELISA were validated with those of potency test.All of results of this two methods meet is in line with the standard requirement of ＂The Chinese Pharmacopoeia,Section Ⅲ,2005＂.Since the Sandwith ELISA method are of the excellent specificity and sensitivity,this method can be applied to the quality control of APV.

关 键 词：无细胞百日咳疫苗 ELISA 质量控制 

分 类 号：TQ464[化学工程—制药化工]