摘要
目的 分析热处理对冻干静脉注射用人免疫球蛋白 (IVIG)的理化性质和生物学功能的影响 ,探索冻干IVIG热处理灭活病毒的可行性和最佳条件。方法 分别采用 80℃ 72h水浴、1 0 0℃ 30min水浴、1 0 0℃ 30min干热 3种条件对冻干IVIG进行热处理处理 ,并测定处理后样品的各种理化性质和Fc段功能。结果 3种方式处理制品均符合规程的要求 ,其中以 1 0 0℃ 30min水浴最适合规模化生产要求 。
OBJECTIVE To explore the feasibility and optimal conditions of the virus inactivated freeze-dryed IVIG by means of heat-treatment.METHODS Freeze-dryed IVIG was treated under the conditions of 80℃ 72 h in water bath, 100℃ 30 min in water bath and 100℃ 30 min in oven,respectively. Samples before and after heating were taken to investigate the influence of the heating on the physical-chemical properties and the function of Fc fragment of the treated IVIG.RESULTS & CONCLUSION All samples have achieved the requirements of the regulation, but the product treated in water bath at 100℃for 30 min had the best examination results, and this heating method (100℃30 min in water bath) is most easily scaled up to mass production.
出处
《华西药学杂志》
CAS
CSCD
2002年第5期345-347,共3页
West China Journal of Pharmaceutical Sciences
