HPLC多柱系统在重组人肿瘤坏死因子衍生物鉴别分析中的应用  

HPLC Multi-Column System Applied for Identity Tests on Recombinant Human Tumor Necrosis Factor

作　　者：杨昭鹏[1] 李赣忠[1] 徐康森[1] 

机构地区：[1]中国药品生物制品检定所生化药品与基因工程药物室

出　　处：《药物分析杂志》1998年第1期6-9,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：采用反相高效液相色谱（ＲＰ－ＨＰＬＣ）、高效凝胶过滤色谱（ＨＰＳＥＣ）、高效疏水相互作用色谱（ＨＰＨＩＣ）和高效离子交换色谱（ＨＰＩＥＣ）及肽图谱测定等技术对国内３个厂家的重组人肿瘤坏死因子样品进行鉴别和同一性检定，对样品中存在的杂质峰给予了解释．为同类基因工程产品的质量控制提供了切实可行的方法和实验依据．Tumor Necrosis Factor (TNF) has specific effects on killing tumor cells in vitro and in vivo.Recombinant human Tumor Necrosis Factor-α derivatives have been produced by a few companies in our country.Several chromatographic techniques,which included the Reverse-phase High Performance Liquid Chromatography (RP-HPLC),High Performance Hydrophobic Interaction Chromatography (HPHIC),High Performance Size-exclusion Chromatography (HPSEC),High Performance Ion-exchange Chromatography (HPIEC) and Peptides mapping,have been applied to the products delivered by the manufactures for identification and identity Tests.Satisfied explanation on the impurities of genetic engineering products have been given.The experiments will supply reference methods for quality control on homogeneous products.

关 键 词：肿瘤坏死因子 衍生物 鉴别分析 高效液相色谱 

分 类 号：R979.5[医药卫生—药品] R927.11[医药卫生—药学]