本文選題：聚乙二醇　切入點：重組人尿酸氧化酶　出處：《中國藥學雜志》2015年23期

【摘要】：聚乙二醇化重組人尿酸氧化酶(PEG-UOX)是對重組人尿酸氧化酶(UOX)進行聚乙二醇修飾以降低其免疫原性和延長體內(nèi)半衰期為目的的改構藥物。由于它是聚乙二醇隨機多位點修飾的蛋白藥物,使得修飾后的蛋白質在理化性質以及體內(nèi)外活性上的復雜程度都遠遠超出重組人尿酸氧化酶。對于此類藥物,目前國內(nèi)外無標準化的質量分析方法。筆者通過整理、歸納近年來關于聚乙二醇修飾藥物質控分析技術的文獻,對聚乙二醇化重組人尿酸氧化酶的3個關鍵質量控制難點——聚乙二醇對重組人尿酸氧化酶的平均修飾率、修飾均一度以及聚乙二醇在重組人尿酸氧化酶上的修飾位點所涉及的分析手段進行了綜述,以期對國內(nèi)企業(yè)開發(fā)此藥物提供技術指導。
[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.
【作者單位】： 天津大學化工學院;中國食品藥品檢定研究院;
【基金】：國家重大新藥創(chuàng)制課題資助項目(2012ZX09304010)
【分類號】：R96

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本文編號：1695833