毛细管电泳技术在聚乙二醇化蛋白药物质量控制中的应用

发布时间：2018-04-04 02:05

本文选题：毛细管电泳　切入点：聚乙二醇化　出处：《药物分析杂志》2015年11期

【摘要】：毛细管电泳是一种以高压电场为驱动力,熔融石英毛细管为分离通道的液相微分离技术。该技术样品消耗量少,分离模式灵活多样,能够检测氨基酸、多肽、蛋白质、细胞、病毒颗粒等多种生物样品,较高效液相色谱有更强的样品适应性。目前,该技术呈现了与其他分析技术联用,检测体系芯片化,检测通量不断提高的发展趋势。蛋白分子异质性分析是蛋白质药物质量控制的重要方面。由于聚乙二醇分子本身具有一定程度的异质性,蛋白聚乙二醇化的过程也有可能引入新杂质,因此聚乙二醇化蛋白药物异质性分析更加必要。聚乙二醇修饰蛋白药物质量控制需要说明蛋白质上连接聚乙二醇分子的数量和位置,即需要检测蛋白的聚乙二醇修饰率和聚乙二醇修饰位点。通过回顾近几年毛细管电泳在聚乙二醇化蛋白药物质量控制中的应用,说明不论是传统毛细管电泳系统还是芯片毛细管电泳系统都能够实现多种蛋白药物聚乙二醇修饰率检测,通过毛细管电泳与质谱联用也能够分析蛋白药物聚乙二醇修饰位点。毛细管电泳与应用非常广泛的分子排阻色谱和聚丙烯酰胺凝胶电泳相比,具有分离效果好,分析速度快,定量准确的优势。综上所述,毛细管电泳技术是聚乙二醇化蛋白药物质量控制的一种重要技术手段,在聚乙二醇化蛋白质量控制方面具有广阔的应用前景。
[Abstract]:Capillary electrophoresis (CE) is a liquid phase microseparation technique with high electric field as the driving force and fused quartz capillary as the separation channel.This technique has less sample consumption, more flexible separation patterns, and can detect amino acids, polypeptides, proteins, cells, virus particles and other biological samples, which is more adaptable than high performance liquid chromatography (HPLC).At present, this technology presents the development trend of combining with other analytical techniques, chip detection system and increasing detection flux.Protein molecular heterogeneity analysis is an important aspect of protein drug quality control.Due to the heterogeneity of polyethylene glycol molecule and the possibility of introducing new impurities into the process of protein polyethylene glycol, it is more necessary to analyze the heterogeneity of polyethylene glycol protein drugs.The drug quality control of PEG-modified protein requires that the number and position of PEG-linked molecules on the protein should be explained, that is to say, the polyglycol modification rate and the peg-modified site of the protein should be detected.By reviewing the application of capillary electrophoresis in the quality control of pegylated protein drugs in recent years, it is shown that both the traditional capillary electrophoresis system and the chip capillary electrophoresis system can be used to detect the polyethylene glycol modification rate of many protein drugs.Capillary electrophoresis and mass spectrometry can also be used to analyze the modified sites of the protein drug polyethylene glycol.Compared with the widely used molecular exclusion chromatography and polyacrylamide gel electrophoresis, capillary electrophoresis has the advantages of good separation effect, fast analysis speed and accurate quantitative analysis.In conclusion, capillary electrophoresis (CE) is an important technique for the quality control of PEGPs, and has a broad application prospect in the field of PEG-protein quantity control.
【作者单位】：成都生物制品研究所有限责任公司;
【分类号】：R917

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