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用RP-HPLC法对基因工程人胰岛素纯度的评价 被引量:2

Evaluation of purity for recombinant human insulin by RP-HPLC
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摘要 用国际(EP、IP、USP)[1]推荐的RP-HPLC法,在美国VydacProteinorPeptideC18柱上进行胰岛素的纯度试验,解决了动物实验无法控制样品的纯度问题。该方法获得了良好的精密度,选择性和分高效果,同时,与国产普通C18柱进行了对比实验。 The desamido insulin and polymers may emerge in the processes of production and storage of insulin injection by some outside elements. testing and controling the limiting of the components are important to the quality of insulin injection. A Vydac protein/peptide reverse phase columns (USA) was applied for purity of insulin by HPLC used in BP,JP and USP. A domestic reverse phase column (Kromasile C18 5μm column) was also used. The method has replaced animal response assay method in testing purity of insulin preparation the method has a good precision selectivity and separation effects.
出处 《天津药学》 1998年第2期76-78,共3页 Tianjin Pharmacy
关键词 基因工程 人胰岛素 聚合体 RP-HPLC法 recombinant human insulin, RP-HPLC, desamido insulin, polymers
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