| 重组人骨形成蛋白-2的质量控制 |
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| 引用本文： | 史新昌,韩春梅,李响,刘兰,丁有学,饶春明.重组人骨形成蛋白-2的质量控制[J].粉末涂料与涂装,2008,21(7):608-610. |
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| 作者姓名： | 史新昌 韩春梅 李响 刘兰 丁有学 饶春明 |
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| 作者单位： | 中国药品生物制品检定所生化室 北京100050 |
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| 摘 要： | 目的建立重组人骨形成蛋白-2(rhBMP-2)质控方法和质量标准。方法以小鼠体内异位成骨试验测定rhBMP-2的生物学活性,HPLC-SEC法测定纯度,蛋白N-末端测序仪测定N-末端15个氨基酸残基序列,其余检测项目按《中国药典》三部(2005版)规定进行。结果1批rhBMP-2原液鉴定结果显示,样品比活性为5.9×104BU/mg,纯度为97.6%,N-末端序列为(MKR)LKSSCKRHPLYV,其余项目检测结果均符合《中国药典》三部(2005版)的要求。结论该质控标准可用于rhBMP-2产品的常规检定。
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| 关 键 词： | 重组人骨形成蛋白-2 质量控制 标准 |
Quality Control of Recombinant Human Bone Morphogenetic Protein-2 |
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| SHI Xin-chang,HAN Chun-mei,LI Xiang,et al.Quality Control of Recombinant Human Bone Morphogenetic Protein-2[J].Chinese Journal of Biologicals,2008,21(7):608-610. |
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| Authors: | SHI Xin-chang HAN Chun-mei LI Xiang |
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| Abstract: | Objective To establish the method and standard for quality control of recombinant human bone morphogenetic protein-2 (rhBMP-2). Methods Determine one batch of rhBMP-2 bulk for biological activity by ectopic bone formation test in mice, for purity by HPLC-SEC, for the sequence of 15 amino acid residues at N-terminus by protein sequencer. Other tests were performed according to the requirements in Chinese Pharmacopoeia (Volume Ⅲ, 2005 edition). Results The specific activity, purity and sequence of 15 amino acid residues at N-terminus were 5. 9 × 104 BU / mg, 97. 6% and (MKR)LKSSCKRHPLYV respectively. Other quality indexes met the requirements in Chinese Pharmacopoeia (Volume Ⅲ, 2005 edition). Conclusion The established method and standard were suitable for the routine quality control of rhBMP-2. |
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| Keywords: | Recombinant human bone morphogenetic protein-2 (rhBMP-2) Quality control Standard |
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