应用噬菌体进行炭疽疫苗纯菌检查方法的建立  

Application of phage for the detection of purity of anthrax vaccine

作　　者：魏东[1] 李恪梅[1] 王国治[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《国际检验医学杂志》2012年第13期1537-1538,1541,共3页International Journal of Laboratory Medicine

基　　金：国家科技重大专项课题资助项目(2009ZX10004-804)

摘　　要：目的建立应用噬菌体进行炭疽活疫苗纯菌检查的方法,并与现用纯菌检查方法进行比较。方法使用噬菌体对与炭疽芽孢杆菌分类学上接近以及常见污染细菌进行裂解观察,确定噬菌体特异性。选取具有代表性的可能污染菌定量掺入炭疽疫苗中,制备模拟污染疫苗,进行噬菌体裂解纯菌检查方法的灵敏度研究,同时与现用的直接接种纯菌检查方法进行比较。结果炭疽噬菌体能特异地裂解炭疽芽孢杆菌,对与炭疽芽孢杆菌分类学上接近以及常见污染细菌无裂解作用。噬菌体裂解法对掺入炭疽疫苗中蜡样芽孢杆菌、枯草芽孢杆菌及大肠埃希菌的检出限均为1CFU/人份,而现用纯菌检查方法的检出限分别为5、5及50CFU/人份。结论噬菌体裂解法检测炭疽活疫苗中污染菌有较好的特异性和灵敏度,该方法的应用对疫苗质量控制具有重要意义。Objective To develop phage lysis method for the detection of purity of anthrax vaccine and to compare phage lysis method with the routine method.Methods Nine strains of non-Bacillus anthracis were lysed with anthrax phage to evaluate the specificity of phage.The quantified three strains of non-Bacillus anthracis were respectively added into anthrax vaccine to evaluate the sensitivity of phage,which was compared with the routine method.Results The anthrax phage could lyse Bacillus anthracis and without cross-reaction with other strains of non-Bacillus anthracis.The detection limit of phage lysis method for detection of Bacillus cereus,Bacillus subtilis and Escherichia coli,which were added into anthrax vaccine,were all 1 CFU/dose.The detection limit of routine method for Bacillus cereus,Bacillus subtilis and Escherichia coli were 5,5 and 50 CFU/dose.Conclusion Phage lysis method might be sensitive and specific for detection of purity of anthrax vaccine.This method could be with the potential to be used as a supplementary method for quality control of anthrax vaccine.

关 键 词：炭疽疫苗 噬菌体 纯菌检查 质量控制 

分 类 号：R392[医药卫生—免疫学]