多糖类生化药物的质控策略与质控技术研究进展

Quality Control Strategies and Research Progress in Quality Control Technology of Polysaccharide Biochemical Drugs

对近年来多糖类生化药物质量控制技术和研究做整理分析。查阅近年来的国内外文献和实际工作实例,进行全面综合、整理和归纳。多糖药物质量控制难度较大,多糖质量控制应从定性、定量和安全性3个方面展开,可应用多角度激光光散射技术、离子色谱技术、液相色谱技术、核磁共振技术及红外光谱技术等多种技术和方法,对多糖药物理化性质、相对分子质量分布、糖组成与糖结构、含量、杂质控制及安全性检查项目等方面进行全面控制。

To analyze the quality control technologies and research of polysaccharides in recent years.By searching the domestic and international literatures and practical experiences in recent years,a comprehensive integrated progress was collated and induced.Polysaccharide drugs have complex structures and their quality control is difficult.The quality control of polysaccharides should be carried out from three aspects:qualitive test,quantitative test,and safety test.Various technologies and methods such as infrared spectroscopy technology,multi-angle laser light scattering,ion chromatography,liquid chromatography,and nuclear magnetic resonance techniques should be used comprehensively to control the physical properties,molecular weight distribution,sugar composition and sugar structure,content,impurity control,and safety of polysaccharide drugs.