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

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 fractioned 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 fractionation was easy to be controlled,which further stabilize the quality of products.