检测CHO基因工程乙肝疫苗残余DNA方法的建立和应用  

Establishing a Method to Detect the Residual CHO Cell DNA for CHO Cell Recombinant HB Vaccine

作　　者：王佑春[1] 吴小音[1] 李河民[1] 

机构地区：[1]中国药品生物制品检定所

出　　处：《微生物学免疫学进展》1995年第3期133-135,共3页Progress In Microbiology and Immunology

摘　　要：对样品的处理方法进行了探索，最后选用一个疫苗剂量的蛋白酶Ｋ同时消化样品和标准ＤＮＡ，并将消化处理后的样品和标准ＤＮＡ用地高辛标记的探针进行检测，灵敏度达１０ｐｇ。共检测２１批检品，除一批ＤＮＡ残余量超过１００ｐｇ／ｄｏｓｅ以外，其它２０批样品的ＤＮＡ残余量均低于１００ｐｇ／ｄｏｓｅ。The CHO cell recombinant HB vaccine and CHO cell DNA standard were detected for residual CHO cell DNA with digoxigenin labelling probe after they were digested with protease K at the same condition. The sensitivity of this test was 10pg and 21 lots samples were tested with this method. The CHO cell DNA for one lot was more than 100pg/dose and for other twenty lots were less than 100pg/dose.

关 键 词：乙型肝炎疫苗 CHO基因工程 DNA探针 

分 类 号：R512.620.3[医药卫生—内科学] R392－33[医药卫生—临床医学]