| 重组白细胞抑制因子和水蛭肽嵌合蛋白质量标准研究 |
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| 引用本文： | 辛中帅,李克坚,杨化新,梁成罡.重组白细胞抑制因子和水蛭肽嵌合蛋白质量标准研究[J].中国新药杂志,2008,17(21). |
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| 作者姓名： | 辛中帅 李克坚 杨化新 梁成罡 |
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| 作者单位： | 中国药品生物制品检定所,北京,100050 |
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| 摘 要： | 目的:建立重组白细胞抑制因子和水蛭肽嵌合蛋白(TNHH)的质控方法和质量标准.方法:采用抗凝血酶活性试验和抗白细胞黏附试验测定活性;通过胰蛋白酶消化分析该蛋白还原型肽图;利用RP-HPLC法和SEC-HPLC法分别测定有关物质和高分子蛋白质含量;其余检测项目均按<中华人民共和国药典)2005版三部相关规定进行.结果:用建立的方法分别对一批TNHH原液和成品进行了检定,各项指标均符合<入用重组DNA制品质量控制技术指导原则>和现版<中华人民共和国药典>的要求.结论:建立的质控方法可有效地控制TNHH产品质量,并可用于TNHH原液及成品的常规检定.
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| 关 键 词： | 白细胞抑制因子 水蛭肽 质量标准 |
Study on specifications for quality control of recombinant neutrphil inhibitory factor and hirulog hybrid |
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| XIN Zhong-shuai,LI Ke-jian,YANG Hua-xin,LIANG Cheng-gang.Study on specifications for quality control of recombinant neutrphil inhibitory factor and hirulog hybrid[J].Chinese Journal of New Drugs,2008,17(21). |
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| Authors: | XIN Zhong-shuai LI Ke-jian YANG Hua-xin LIANG Cheng-gang |
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| Institution: | National Institute for the Control of Pharmaceutical and Biological Products;Beijing 100050;China |
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| Abstract: | Objective:To establish methods and specifications for quality control of recombinant neutrphil inhibitory factor and hirulog hybrid(TNHH).Methods: Biological activity of TNHH was determined by anti-thrombin assay and anti-leucocyte cell adhesion assay.Reduced peptide mapping was analyzed by trypsin digestion and following RP-HPLC.Related compounds and high molecular weight proteins were analyzed by RP-HPLC and SEC-HPLC.Other tests were performed according to the requirements of Chinese Pharmacopoeia.Results... |
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| Keywords: | neutrphil inhibitory factor hirulog specification |
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