PEG化重组人促红素质量控制方法和标准研究

目的: 建立PEG化重组人促红素质量控制方法和质量标准。 方法: 用正常小鼠网织红细胞计数法测定体内生物学活性,使用iCE毛细管等电聚焦电泳分析异构体,用离子色谱确定N-糖链指纹图谱,反相HPLC进行Lys-C蛋白内切酶酶切的肽图分析以及纯度测定。其余检测项目按2010年版中国药典三部方法进行。 结果: 建立的方法经过比较和对PEG化重组人促红素的检测,结果稳定可靠,重复性好,各指标符合《人用重组DNA制品质量控制技术指导原则》和2010年版中国药典三部的要求。 结论: 本研究建立了一套完善的PEG化重组人促红素质量控制体系。

Objective: To establish methods and requirements for the quality control of PEG-EPO. Methods: In vivo bioactivity of PEG-EPO was determined by the count of reticulocytes in normocythaemic mice.Isoforms were analyzed by cIEF.Oligosaccharide fingerprint profiling was determined by HPAEC.Purity and peptide mapping were analyzed by reverse HPLC system.Other routine tests were all carried out according to the Chinese pharmacopoeia(volume Ⅲ,2010 edition). Results: The requirements and methods for the quality control of PEG-EPO have been established.The results of all tests were reliable and reproducible,and complied with the Chinese pharmacopoeia and guidelines for the quality control of recombinant DNA products. Conclusion: The methods and requirements for PEG-EPO showed the characteristics of assuring the products safety and efficacy,which can be used for the quality control of PEG-EPO.

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