长效人红细胞生长刺激蛋白质量控制标准研究  

Study on the specification for quality control of novel erythropoiesis stimulating protein(NESP)

作　　者：周勇[1,2] 黄培堂[2] 杨鹏云[1] 王敏力[1] 肖林[1] 程雅琴[1] 王军志[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]军事医学科学院,北京100850

出　　处：《药物分析杂志》2008年第10期1597-1601,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：国家863高科技研究发展计划项目(2003AA2Z3480)

摘　　要：目的:建立长效人红细胞生长刺激蛋白质量控制方法和质量标准。方法:用 UT-7细胞依赖株和 ELISA 测活法测定生物学和免疫学活性,使用高效液相色谱系统分析 N-糖链结构、测定纯度,及胰蛋白酶酶切的肽图分析.等电聚焦电泳分析异构体,使用比色法检测唾液酸含量。其余检测项目按2005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长效人红细胞生长刺激蛋白的检测,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2005年版中国药典三部的要求。结论:本研究建立了一套完善的长效人红细胞生长刺激蛋白质量控制体系。Objective：To establish methods and requirements for quality control of novel erythropoiesis stimulating protein（NESP）. Method：Bioactivity and immunoactivity of NESP were respectively determined by UT -7 cell and ELISA. N - linked carbohydrates,purity and peptide mapping were analysed by respective HPLC systems. The isomeride of NESP was assayed by isoelectric focusing（lEF）. Sialic acid content was detected by colorimeter. The rest routine tests were all analysed according to the Chinese Pharmacopoeia（2005. volume Ⅲ）. Results：The requirements and methods for quality control of NESP had been established. The results of all test were reliable and duplicable. The specification complied with the Chinese Pharmacopoeia and guidelines for quality control of recombinant DNA products. Conclusion：A feasible system for NESP was developed.

关 键 词：长效人红细胞生长刺激蛋白 质量控制 活性 

分 类 号：R917[医药卫生—药物分析学]