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用二硫代苏糖醇还原基因工程药物产品中的二硫键,并用碘乙酰胺封闭巯基,再用胰蛋白酶裂解,经微柱高效液相色谱分离分析rhG-CSF产品的肽谱,3个批号批间结果完全一致。该方法具有系统操作误差小,用样品量少,较常现高效液相色谱检测灵敏度高,重视性好的优点。是适用于基因工程药物产品肽谱分析,衡量产品生产纯化工艺稳定性比较优秀的方法之一。
Dithiothreitol was used to reduce the disulfide bonds in genetically engineered drug products and the thiol groups were blocked with iodoacetamide. The peptide was cleaved with trypsin. The peptide profiles of rhG-CSF were separated and identified by micro-column high performance liquid chromatography. Three Batch batch results exactly the same. The method has the advantages of small system operation error, less sample amount, higher detection sensitivity and more importance than high performance liquid chromatography. It is one of the best methods to measure peptide spectrum of genetically engineered drug products and measure the stability of product purification process.