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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 ,用BET法代替RPT法检测上述细胞因子制品的细菌内毒素及其质量控制是可行的
In order to investigate the bacterial endotoxin test (BET method) to detect recombinant human cytokine products of bacterial endotoxin and its feasibility of quality control. According to the regulations of China Biological Products Regulations of 2000, the L value was determined, the MVD was calculated, and the interference test was conducted to test the bacterial endotoxin of the products and compared with the rabbit pyrogen method (RPT method). The results showed that the highest sensitivity of 0.125EU / ml of 鲎 reagent, recombinant human interferon α2a (IFNα2a), granulocyte macrophage colony stimulating factor (GM CSF), interleukin 2 (IL 2) products, the highest non-interference The concentrations were diluted to 1.7 times (95,000 IU / ml), 10.9 times (21,500 μg / ml) and 40 times (0. 25,000 IU / ml), respectively. IFNα2a and GM CSF according to the rules of the provisions of 80-fold dilution, the detection of bacterial endotoxin were no interfering effect, and IL 8 diluted 8 times the test inhibition, but 40-fold dilution can eliminate inhibition. The bacterial endotoxin of the above products was detected by BET method and the pyrogen of rabbits by RPT method. The coincidence rate was 100%. The results suggest that it is feasible to use BET method instead of RPT method to detect bacterial endotoxin and its quality control in the above cytokine preparations