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重组(CHO细胞)乙型肝炎疫苗细菌内毒素含量检测法的建立
引用本文:陈万革,金立杰,罗璇,蔡岩.重组(CHO细胞)乙型肝炎疫苗细菌内毒素含量检测法的建立[J].微生物学杂志,2002,22(4):34-35.
作者姓名:陈万革  金立杰  罗璇  蔡岩
作者单位:长春生物制品研究所,吉林,长春,130062
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 ,疫苗中内毒素含量全部合格

关 键 词:乙型肝炎疫苗  细菌内毒素  鲎试剂
文章编号:1005-7021(2002)04-0034-02
修稿时间:2001年10月18

Assay Establishment of Baterial Endotoxin Content in Recombinant CHO Cells Hepatitis B Vaccine
CHEN Wan''''ge,JIN Lijie,LUO Xuan,CAI Yan.Assay Establishment of Baterial Endotoxin Content in Recombinant CHO Cells Hepatitis B Vaccine[J].Journal of Microbiology,2002,22(4):34-35.
Authors:CHEN Wan'ge  JIN Lijie  LUO Xuan  CAI Yan
Abstract: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.
Keywords:hepatitis B vaccine  bacterial endotoxin  TAL  
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