聚乙二醇化重组人尿酸氧化酶质控难点研究进展

发布时间：2018-04-01 13:34

本文选题：聚乙二醇　切入点：重组人尿酸氧化酶　出处：《中国药学杂志》2015年23期

【摘要】：聚乙二醇化重组人尿酸氧化酶(PEG-UOX)是对重组人尿酸氧化酶(UOX)进行聚乙二醇修饰以降低其免疫原性和延长体内半衰期为目的的改构药物。由于它是聚乙二醇随机多位点修饰的蛋白药物,使得修饰后的蛋白质在理化性质以及体内外活性上的复杂程度都远远超出重组人尿酸氧化酶。对于此类药物,目前国内外无标准化的质量分析方法。笔者通过整理、归纳近年来关于聚乙二醇修饰药物质控分析技术的文献,对聚乙二醇化重组人尿酸氧化酶的3个关键质量控制难点——聚乙二醇对重组人尿酸氧化酶的平均修饰率、修饰均一度以及聚乙二醇在重组人尿酸氧化酶上的修饰位点所涉及的分析手段进行了综述,以期对国内企业开发此药物提供技术指导。
[Abstract]:Polyethylene glycol (PEG-UOX) is a recombinant human uric acid oxidase modified by polyethylene glycol to reduce its immunogenicity and prolong its half-life in vivo.Because it is a polymorphic protein drug modified by polyethylene glycol at random, the complexity of the modified protein in physical and chemical properties and in vitro and in vivo activity is far beyond that of recombinant human uric acid oxidase.There are no standardized quality analysis methods for such drugs at home and abroad.The author summarized the literature on quality control analysis of polyethylene glycol modified drugs in recent years.The average modification rate of polyethylene glycol on recombinant human uric acid oxidase was studied.The methods involved in the modification of homogeneity and the modification site of polyethylene glycol on recombinant human uric acid oxidase were reviewed in order to provide technical guidance for domestic enterprises to develop this drug.
【作者单位】：天津大学化工学院;中国食品药品检定研究院;
【基金】：国家重大新药创制课题资助项目(2012ZX09304010)
【分类号】：R96

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