95%乙醇循环系统对人血白蛋白质量的影响分析  

Effect of 95% ethanol circulation system on quality of human albumin

作　　者：李璐[1,2] 兰学渊 林宏辉[1] 

机构地区：[1]四川大学生命科学学院,四川成都610064 [2]成都蓉生药业有限责任公司,四川成都610041

出　　处：《中国生物制品学杂志》2017年第7期747-750,共4页Chinese Journal of Biologicals

摘　　要：目的分析采用低温乙醇工艺制备人血白蛋白时,95%乙醇循环系统对人血白蛋白原液的超滤收率和成品各项质量指标的影响。方法在多批次规模化生产中,分别测定对95%乙醇新增乙醇循环系统前后人血白蛋白原液的超滤收率和成品的纯度、多聚体含量、激肽释放酶原激活剂(prekallikrein activator,PKA)等指标,并将测定结果进行对比。结果新增乙醇循环系统后,人血白蛋白成品的纯度明显升高(P<0.001),多聚体含量明显下降(P<0.001),PKA无明显变化;同时,人血白蛋白原液超滤收率呈稳定趋势,未表现出明显变化。结论在低温乙醇工艺制备人血白蛋白的过程中,对95%乙醇使用乙醇循环系统自动控制添加过程,可降低操作难度,提高工作效率及操作精细度,更好地实现制品分离过程,进一步提升人血白蛋白产品的质量。Objective To investigate the effect of 95% ethanol circulation system on the ultrafiltration yield and quality indexes of bulk of human albumin during production by cold ethanol fractionation. Methods The ultrafiltration yield of bulk as well as purity, polymer content and prekallikrein activator（PKA） of final product of human albumin after introduction of circulation system for addition of 95% ethanol into multi-batch of large-scale production, and the results were compared with those before introduction of the system. Results After introduction of the circulation system, the purity of final product of human albumin increased significantly（P 0. 001）, while the polymer content decreased significantly（P 〈 0. 001）, and PKA showed no significant change. Meanwhile, the ultracentrifugation yield of bulk of human albumin showed a stable tendency without significant change. Conclusion The control of addition process of 95%ethanol by using ethanol circulation system during production of human albumin by cold ethanol fractionation showed reduced operation difficulty, improved work efficiency and improved operation precision, by which the procedure for fractionation was more effective, and the quality of human albumin was further improved.

关 键 词：人血白蛋白 95%乙醇 乙醇循环系统 纯度 多聚体含量 

分 类 号：R392-33[医药卫生—免疫学]