| 重组人促红素糖指纹图谱分析技术研究 |
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| 引用本文： | 周勇,邵宝珠,YUEN Chun-ting,王丽,王军志. 重组人促红素糖指纹图谱分析技术研究[J]. 药物分析杂志, 2012, 0(4): 587-591 |
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| 作者姓名： | 周勇 邵宝珠 YUEN Chun-ting 王丽 王军志 |
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| 作者单位： | 中国食品药品检定研究院;沈阳三生制药有限责任公司;National Institute for Biological Standardsand Control(NIBSC) |
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| 基金项目： | 国家“重大新药创制”科技重大专项项目(2009ZX09307-001) |
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| 摘 要： | 目的:建立重组人促红素N-糖链特征性糖指纹图谱检测分析技术。方法:分别用外切糖苷酶(PNGase F)和神经氨酸酶酶切重组人促红素,超滤离心获得糖的各种组分,使用高pH离子色谱分析N-糖链的结构和组成并确定N-糖链指纹图谱。结果:建立的方法稳定可靠,重复性好,可用于重组人促红素糖结构和组成的研究和质量控制。结论:本研究建立了简便、有效的重组人促红素N-糖链特征性糖指纹图谱检测分析方法。
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| 关 键 词： | 糖蛋白激素 重组人促红素(rHuEPO) 糖指纹图谱 特征图谱 酶切图谱 糖谱分析技术 |
Study on methods of glycans for erythropoietin(EPO) |
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| ZHOU Yong,SHAO Bao-zhu,YUEN Chun-ting,WANG Li,WANG Jun-zhi. Study on methods of glycans for erythropoietin(EPO)[J]. Chinese Journal of Pharmaceutical Analysis, 2012, 0(4): 587-591 |
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| Authors: | ZHOU Yong SHAO Bao-zhu YUEN Chun-ting WANG Li WANG Jun-zhi |
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| Affiliation: | 1 (1.National Institutes for Food and Drug Control,Beijing 100050,China;2.Shenyang Sunshine Pharmaceuticals Co,Ltd.Shenyang 110141,China,3.National Institute for Biological Standards and Control(NIBSC),Potters Bar,Herts.EN6 3QG,UK) |
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| Abstract: | Objective:To establish analytical methods for N-glycans finger printing of human recombinant erythropoietin(rHuEPO).Methods:The N-glycosidically-linked oligosaccharide chains and the terminal sialic acid residues of rHuEPO are released from the glycoprotein by N-glycosidase F and neuraminidase digestion separately.After removal of the protein fraction,the resultiant oligosaccharides are chromatographically separated using high pH anion-exchange chromatography with pulsed amperometric detection(HPAEC-PAD).Results:The methods are well suited for the study and quality control of N-glycans structure and composition of rHuEPO,and the results of all tests were reliable and reproducible.Conclusion:The analytical methods of characteristic N-glycans finger printing have been established for the analysis and quality control of rHuEPO N-glycans. |
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| Keywords: | glycoprotein hormone recombinant human erythropoietin(rHuEPO) glycans finger printing characteristic chromatogram macrorestriction map sugar spectrum analysis technology |
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