FVⅢ浓制剂生产工艺的改进

作者于常规制备工艺中增加一步酸沉淀,加上超滤浓缩,可使制品纯度有较大提高。本工艺制备的镧品,在适宜稳定剂保护下,能耐受80℃、72小时的剧烈干热处理。3批小量制备的结果显示制品的平均效价为28.7±2.4μ/ml,平均比活为1.14±0.11u/mg。对冷沉淀抽提液的活性总回收为602以上。热处理制品经3名甲种血友病人初步临床输用观察结果表明安全有效,平均体内活性回收为98.1±31.7％.半衰期为8～12小时。

Improved Manufacturing Process of FVⅢ Concentrate to Tolerate Severe Dry Heat-Treatment

An improved manufacturing process of FVⅢ concentrate was presented. By adding acid precipitation and ultrafiltration steps to the routine process, the product thus prepared had a much higher purity, and under the protection of suitable stabilizer could tolerate the severe dry heat-treatment at 80℃ for 72 hours. Results from three pilot production batches showed an average potency of 28.7±2.4 U/ml and a mean specific activity of 1.14 ± 0.11U/rag protein. The total recovery of activity from cryoprecipi tate extract was above60%. Preliminary clinical observation on three hemophilia A patients demonstrated the heat-treated product to be safe and effective with an average in vivo recovery of 98.1 ±31.7% and a half di sappearence time of 8 to 12 hours.