人血白蛋白及人免疫球蛋白类制品的纯度测定

Determination of the Purities of Human Albumin and IgG Products

目的:比较琼脂糖凝胶电泳法、毛细管区带电泳法与中国药典品种项下规定的醋酸纤维素薄膜电泳法测定人血白蛋白及人免疫球蛋白类制品纯度的结果差异。方法:将人血白蛋白及人免疫球蛋白类制品均制备成蛋白浓度为5%的溶液,分别采用全自动醋酸纤维素薄膜电泳仪、全自动琼脂糖凝胶电泳仪及全自动毛细管电泳仪进行测定,均以峰面积归一化法计算纯度。结果:除毛细管区带电泳法测得的人血白蛋白大部分结果不符合中国药典2015年版品种项下的标准限度外,另外两种方法测得的人血白蛋白结果及人免疫球蛋白类制品3种测定方法的结果均分别符合中国药典2015年版品种项下的标准限度。结论:初步判定琼脂糖凝胶电泳法和毛细管区带电泳法均可用于人血白蛋白及人免疫球蛋白类制品的纯度的测定。

Objective:To compare cellulose acetate method,agarose gel method and capillary zone electrophoresis for the purity determination of human albumin and Ig G products.Methods:The sample was prepared into a solution with the protein concentration of 5%,determined respectively by cellulose acetate method,agarose gel method and capillary zone electrophoresis,and calculated by area normalization method.Results:Most of the results of albumin determined by capillary zone electrophoresis didn’t meet the requirement of ChP2015,while the results from the other two methods all met the requirement,and all the results of Ig G products determined by the three methods met the requirement.Conclusion:Both garose gel method and capillary zone electrophoresis are suitable for determining the purities of human albumin and Ig G products.