目的　制备符合临床应用质量标准的鼠源性 m Ab F(ab′) 2 片段 .方法　采用胃蛋白酶消化小鼠腹水抗体 ,疏水作用色谱法纯化 F(ab′) 2 片段的新工艺 ,替代原有的木瓜蛋白酶消化 Ig G,阴离子交换色谱法纯化的旧工艺 .结果　新工艺所制备的 F(ab′) 2 片段经 SDS- PAGE检测纯度达 98%以上 ,ABC免疫组化法测定免疫活性为 1∶ 80 0 0 ,回收率大于 5 0 % ,核酸含量及热原均合格 ,整个工艺流程可在 48h内完成 .结论　新工艺制备人用鼠源性 m Ab F(ab′) 2 片段更简便高效、安全实用 ,能够适应中试放大及大规模生产的要求 Objective To prepare a mouse-derived m Ab F(ab’) 2 fragment that meets the clinical application quality standards. METHODS: A new process for the purification of F(ab’) 2 fragments by pepsin digestion of mouse ascites antibodies and hydrophobic interaction chromatography was used. The papain digestion of Ig G, anion exchange chromatography purification of the old process. Results The new process of F (ab’) 2 fragment purity by SDS-PAGE detection of more than 98%, ABC immunohistochemistry method for measuring the immune activity of 1 : 80 0 0 , the recovery rate is greater than 50%, nucleic acid content and pyrogen are all qualified, and the whole process can be completed in 48 hours. Conclusion New process to prepare human-derived m Ab F(ab’) 2 fragments is more convenient and efficient , safe and practical, able to adapt to the requirements of pilot scale-up and large-scale production