重组(CHO细胞)乙型肝炎疫苗细菌内毒素含量检测法的建立  

Assay Establishment of Baterial Endotoxin Content in Recombinant CHO Cells Hepatitis B Vaccine

作　　者：陈万革[1] 金立杰[1] 罗璇[1] 蔡岩[1] 

机构地区：[1]长春生物制品研究所,吉林长春130062

出　　处：《微生物学杂志》2002年第4期34-35,共2页Journal of Microbiology

摘　　要：采用鲎试剂法检测重组 (CHO细胞 )乙型肝炎疫苗中的细菌内毒素含量 ,研究了甲醛、硫柳汞、氢氧化铝等疫苗成分对鲎试剂试验的影响。结果表明 ,疫苗中各成分对检测未见影响 ,所以检测本疫苗中内毒素含量时 ,采用鲎试剂法是可行的。同时 ,用此试验方法对本室所生产的重组 (CHO细胞 )乙型肝炎疫苗进行了检测 。Bacterial endotoxin in recombinant CHO cells hepatitis B vaccine was determined by TAL (Tachypleus Amebocyte Lysate, or LAL, Limulus Amebocyte Lysate) method. Effects of vaccine components against the TAL test including formaldehyde, ethylmercurithiosalicylate, and aluminum hydroxide were studied. The results showed that all the above mentioned vaccine components have no effects against the test. Therefore, TAL assay is feasible. At the same time, the assay was used to inspect the content of the bacterial endotoxin in the recombinant CHO cell hepatitis B vaccine produced in our institute with qualification.\;

关 键 词：乙型肝炎疫苗 细菌内毒素 鲎试剂 

分 类 号：R392-33[医药卫生—免疫学]