Girard M, Bietlot H P, Cyr T D
Drugs Directorate, Health Canada, Sir F.G. Banting Research Centre, Tunney's Pasture, Ottawa, Ontario, Canada.
J Chromatogr A. 1997 Jun 6;772(1-2):235-42. doi: 10.1016/s0021-9673(97)00099-x.
Human serum albumin (HSA) preparations and HSA-containing recombinant human erythropoietin (rhEPO) formulations were analyzed by capillary zone electrophoresis. HSA was separated into several components by the addition of 1,4-diaminobutane to 20 mM sodium phosphate, pH 6.0 as electrophoretic buffer. Resolution was improved by increasing the buffer pH to 8.5. A comparative analysis of HSA preparations from three manufacturers provided evidence that this method can be used to differentiate individual preparations. The analysis of rhEPO formulations, composed largely of HSA, showed levels of heterogeneity comparable to that of HSA preparations. Electrospray ionisation mass spectrometry was used as an independent method to confirm the heterogeneous nature of HSA.
采用毛细管区带电泳法分析人血清白蛋白（HSA）制剂以及含HSA的重组人促红细胞生成素（rhEPO）制剂。以20 mM磷酸钠（pH 6.0）为电泳缓冲液，添加1,4 - 二氨基丁烷后，HSA被分离为几个组分。将缓冲液pH提高到8.5可改善分离度。对来自三个制造商的HSA制剂进行的对比分析表明，该方法可用于区分不同的制剂。对主要由HSA组成的rhEPO制剂的分析显示，其异质性水平与HSA制剂相当。采用电喷雾电离质谱法作为独立方法来确认HSA的异质性。
