应用生产人白细胞干扰素的沉积物制备人白细胞转移因子的报告

Preliminary Report on Preparation of HuLeTF Using the Leucocyte Precipitate after Preparation of HuleIFN

作者利用生产人白细胞干扰素后的白细胞沉积物按超滤法试制了4批人白细胞转移因子,每批分经酸处理与未经酸处理两个样品。经生物学及生物化学检定。除1个样品的 E260nm/E280nm 比值低于1.8外,其余7个的比值均大于或等于1.8,其他各项质量指标均可达到或符合《人白细胞转移因子制造和检定暂行规程》及有关规程要求。平均收率为1ml TF/6.7×10~8细胞,约为正常白细胞收率的36%。用经酸处理的沉积物制备的转移因子的浓度、多肽和核苷酸含量均较未经酸处理者分别平均低50%、32.9%和43.0%,两者的比值无显著差异。NDV检测结果表明,酸处理和所采用的超滤系统可有效地灭活和截留 NDV 感染颗粒。初步结果证明,利用这种“沉积物”生产人白细胞转移因子是可行的。

Since the collection of human leucocyte is rather difficult,production of Hu-LeTF is limited.4 small hatches of HuLeTF have been prepared with the leucocyte pre-cipitate after preparation of HuLeIFN Each lot was divided into two portions for acid treat-ment and non-acid treatment.By biological and biochemical examination,the ratio valuesof E260 nm/E280nm for all the samples except one attain at and are overl.8.Other qualitycontrol results could all reach and conform to the provisional requirements for productionand testing of HuLeTF,as well as regulations referred.The mean recovery was 1 ml TF/6.7×10~8 cells.It is about 36% of recovery of normal leucocytes.The mean concentration and contents of polypeptide and nucleotide of the samples withacid treatment were 50%,32.9% and 43% lower than that of non-acid treatment.The ratiosbetweenacid and non-acid treatment showed no signifficant difference.The infective particlesof NDV were effectively inactivated by means of acid treatment and intercepted by theultrafi ltration system.The preliminary results showed that it would be feasible to produce HuLeTF using the leucocyteprecipitate.