重组人细胞因子制品细菌内毒素的检测  

Detection of bacterial endotoxin in recombinant human cytokine products

作　　者：李英华[1] 曾艳[1] 陈日兰[1] 孟东方[1] 姜崴[1] 兰燕[1] 杜晶[1] 周丽[1] 左毅[1] 曾繁启[1] 

机构地区：[1]长春生物制品研究所,长春130062

出　　处：《微生物学免疫学进展》2003年第1期11-15,共5页Progress In Microbiology and Immunology

摘　　要：为了考察细菌内毒素检查法 (BET法 )检测重组人细胞因子制品的细菌内毒素及其质量控制的可行性。按照 2 0 0 0年版《中国生物制品规程》的规定 ,确定L值 ,计算MVD ,进行干扰试验 ,检测制品的细菌内毒素 ,并与家兔热原法 (RPT法 )进行比较。结果表明 ,用标示灵敏度为 0 .12 5EU/ml的鲎试剂 ,重组人干扰素α2a(IFNα2a)、粒细胞巨噬细胞集落刺激因子 (GM CSF)、白介素 2 (IL 2 )制品 ,最高非干扰浓度分别为稀释至 3 1.7倍 ( 9.5万IU/ml) ,10 .9倍 ( 2 7.5万 μg/ml) ,40倍 ( 0 .2 5万IU/ml)。将IFNα2a和GM CSF按规程规定稀释 80倍 ,对细菌内毒素的检测均无干扰作用 ,而IL 2稀释 8倍对检测有抑制作用 ,但经 40倍稀释后可消除抑制。以BET法检测上述制品的细菌内毒素和以RPT法测定家兔热原质 ,符合率为 10 0 %。结果提示 。The feasibility study was carried out by endotoxin test(BET)in detection of endotoxin in recombinant human cytokine products, based on 'Requirements for Biological Products of China' year 2000 edition. The results showed that the highest and uninterfering concentration of recombinant human IEFα 2a,GM-CSF and IL_2 were diluted to 31.7 times(9.5×10 4IU/ml),10.9 times(27.5μg/ml) and 40 times (2.5×10 2IU/ml) respectively when they were detected with 0.125EU/ml of TAL(Tachypleus amebocyte lysate).There was no interferring effect in detection of endotoxin when IFNα 2a and GM-CSF were diluted to 80 times. However the restraining effect occurred when IL_2 was diluted to 8 times, which was eliminated when IL_2 was diluted 40 times.The results of detected endotoxin by BET were consistent with that of detected pyogen by RPT (Rabit pyogen test),the confirmation rate reached to 100%. It indicated that BET way be used in detection of endotoxin in place of RPT.

关 键 词：细菌内毒素检查法 鲎试剂 细胞因子制品 

分 类 号：R927[医药卫生—药学]