重组人戊型肝炎疫苗细菌内毒素检查方法的建立  

Development of bacterial endotoxin test(BET) for recombinant human vaccine of hepatitis E

作　　者：应莲芳[1] 杨军[1] 马超[1] 梁凌宇[1] 刘鹏[1] 

机构地区：[1]兰州生物制品研究所,兰州730046

出　　处：《微生物学免疫学进展》2006年第2期15-18,共4页Progress In Microbiology and Immunology

摘　　要：确立重组人戊型肝炎疫苗原液的细菌内毒素检查方法。供试品参照《中华人民共和国药典》(2005年版三部)热原检查法进行热原检查,结果符合规定。该供试品同时参照《中华人民共和国药典》(2005年版三部)细菌内毒素检查法要求进行试验。供试品溶液在40μg/m l浓度下,确定内毒素限值为40EU/m l。供试品在该内毒素限值下干扰试验有效,且细菌内毒素检查法符合规定。该疫苗用内毒素检查法代替热原检查法,方法可行。To develop a method in detection of bacterial endotoxin for recombinant human vaccine of hepatitis E, the experiment was conducted according to BET in China Pharmacopoeia 2005, third section. The protein concentration was less than 40μg/ml, the detection limit for bacterial endotoxin was defined 40EU/ml, with which the tested samples were validated, 160-fold dilution did not interfere with the performed BET. It is feasible for BET in replacement of pyrogen test on rabbit.

关 键 词：重组人戊型肝炎疫苗 细菌内毒素检查方法 

分 类 号：R392[医药卫生—免疫学]