实现自控分离对人血浆蛋白质量的影响

Influence of Fractionation under Automatic Control on Quality of Human Plasma Protein

目的对低温乙醇血浆蛋白分离工艺实现自控后分离的人血浆蛋白各项质量指标和收获率进行评价。方法按照《中国药典》三部(2005版)规定的方法和标准,对低温乙醇工艺实现自控后分离的人血浆蛋白样品各项指标进行测定,并将测定结果与自控前的制品进行比较。结果连续测定实现自控后分离的71批人血白蛋白和52批静注人免疫球蛋白(IVIG)样品,并与实现自控前的82批人血白蛋白、29批静注人免疫球蛋白(IVIG)成品检定结果进行比较,发现人血白蛋白及IVIG的纯度和收获率均有明显提高,多聚体含量明显下降,其他指标(离子含量、吸光度等)均无明显改变,且制品质量稳定,符合《中国药典》三部(2005版)要求。结论低温乙醇分离蛋白实现自控后,进一步提高了人血浆蛋白的质量,使分离过程更加容易控制,制品质量更加趋于稳定。

Objective To evaluate the quality indexes and recovery rate of human plasma protein prepared by fractionation with alcohol at low temperature under automatic control. Methods Test the human plasma protein prepared by fractionation with alcohol at low temperature under automatic control for quality indexes according to the requirements in Chinese Pharmacopoeia（ Volume Ⅲ, 2005 edition） ,and compare the results with those of human plasma protein fracfioned without automatic control. Results The final products of 71 lots of human plasma albumin and 52 lots of human immune globulin for intravenous use（IVIG） fractioned under automatic control, as well as those of 82 lots of human plasma albumin and 29 lots of IVIG fractioned without automatic control, were tested and compared. The results showed that, compared with those fractioned without automatic control,the purities and recovery rates of human plasma albumin and IVIG fractioned under automatic control increased significantly,while polymer contents decreased significantly, and other quality indexes such as ion content and absorbance showed no significant change. The quality of human plasma proteins fractioned under automatic control was stable and met the requirements in Chinese Pharmacopoeia（Volume Ⅲ ,2005 edition）. Conclusion The fractionation with alcohol at low temperature under automatic control improved the quality of human plasma proteins. Meanwhile,the procedure for fracfionation was easy to be controlled ,which further stabihze the quality of products.