琼脂糖凝胶电泳法测定静注人免疫球蛋白纯度

Purity Determination of Human Immunoglobulin for Intravenous Injection by Agarose Gel Electrophoresis

建立了琼脂糖凝胶电泳法测定静注人免疫球蛋白纯度。采用全自动电泳仪及其配套的试剂盒,以0.35%酸性蓝作为染色液,染色液体积为800 μl,加样体积为50 μl,对115批静注人免疫球蛋白样品进行测定,并与醋酸纤维素薄膜法的测定结果进行比较。结果显示,琼脂糖凝胶电泳法定量测定区间为蛋白浓度1%~5%,最低检测浓度为0.5%,精密度试验RSD为0.17%、0.20%。琼脂糖凝胶电泳法与醋酸纤维素薄膜法的检测结果基本一致,但统计学分析显示2种方法的测定结果存在显著性差异,后续将进一步比较研究2种方法存在差异的原因。琼脂糖凝胶电泳法的精密度和耐用性良好,可用于静注人免疫球蛋白纯度测定。

An agarose gel electrophoresis method was established to determine the purity of human immunoglobulin for intravenous injection.The automatic electrophoresis instrument and its matching kit were used,with the 0.35% acid blue as staining solution.The volume of the staining solution was 800 μl,and the sample volume was 50 μl.115 Batches of human immunoglobulin for intravenous injection samples were tested,and results were compared with those of the cellulose acetate membrane electrophoresis method.The results showed that the quantitative determination interval of agarose gel electrophoresis was that the protein concentration was 1% to 5%.The minimum detection protein concentration was 0.5% and the precision test RSDs were 0.17% and 0.20%.The observation results of agarose gel electrophoresis method and cellulose acetate membrane electrophoresis method were similar,but the statistical analysis showed that the measurement results of two methods were significantly different.The reason for the difference between the two methods will be studied in the future.The agarose gel electrophoresis method is precise and durable,which can be used to determine the purity of human immunoglobulin for intravenous injection.