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我们对批量生产临床级人血白细胞干扰素的工艺作了改进,指出:配制培养液最好使用玻璃器皿制备的三蒸水或离子水,否则干扰素产量下降2～4倍;在培养过程中细胞如凝成团块,可使产量下降63%;培养液的最适pH值应为7.0～7.2;用NaHCO_8缓冲系统时,不通气转床培养较通气为好。每一单位血(200ml)可制备干扰素0.48×10~(?)u。在4名健康人中作了药物动力学试验,证明肌注6小时体内血清中干扰素水平达高峰。在15例肿瘤患者中作了临床Ⅰ期试验,除个别患者有低烧、疲倦外无其他副反应。
We improved the process of mass production of clinical grade human leukocyte interferon, and pointed out that it is better to use the three-distilled water or ionized water prepared from glassware to prepare the culture broth, otherwise, the interferon production will be reduced by 2 to 4 times. During the cultivation process Cells such as clumps, can reduce the yield of 63%; the optimum pH of the culture medium should be 7.0 to 7.2; with NaHCO_8 buffer system, the ventilation is not ventilated bed culture is better than ventilation. Each unit of blood (200ml) can produce interferon 0.48 × 10 ~ (?) U. Pharmacokinetic tests were performed in four healthy individuals and demonstrated that interferon levels peaked within 6 hours of intramuscular in vivo. A clinical phase I trial was performed in 15 cancer patients, with no other side effects other than individual patients having low-grade fever and tiredness.