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按照美国的最低要求,吸附白喉类毒素的效力试验是在豚鼠体内进行毒素中和(TN)试验滴定免疫豚鼠血清中的白喉抗毒素,该试验豚鼠用量大且麻烦。为此,本文作者使用体外Vero细胞法滴定免疫豚鼠血清的白喉抗毒素,并与体内TN法进行了比较。 在Vero细胞法中所用的一个毒素剂量称为Lcd/1,即与1IU/ml的标准白喉抗毒素等体积混合后在4天时引起约50%的Vero
In accordance with the U.S. minimum requirement, the diphtheria toxin-binding potency test is performed in a guinea pig toxin-neutralizing (TN) assay to titrate the diphtheria antitoxin in guinea pig serum, which is bulky and cumbersome. To this end, the authors use in vitro Vero cell titration immunization guinea pig serum anti-diphtheria anti-toxin and in vivo TN method were compared. One dose of toxin used in the Vero cell-based method, referred to as Lcd / 1, elicited about 50% of Vero at 4 days after mixing with an equal volume of 1 IU / ml of standard diphtheria antitoxin