PEG化重组人促红素质量控制方法和标准研究  

Study on methods and requirements for quality control of Pegylated Erythropoietin(PEG-EPO)

作　　者：周勇[1] 王丽[1] 于传飞[1] 杨鹏云[1] 王箐舟[1] 侯继锋[1] 王军志[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2012年第4期661-664,649,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：国家"重大新药创制"科技重大专项项目(2009ZX09307-001)

摘　　要：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 vi- vo 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 m ,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.

关 键 词：PEG化重组人促红素 活性 红细胞计数法 毛细管等电聚焦电泳 离子色谱 反相高效液相 糖链指纹图谱 肽图分析 纯度测定 

分 类 号：R917[医药卫生—药物分析学]