糖类药物制药生产工艺及其质量控制方法研究进展

Research Progress on Production Processes and Quality Control Methods of Carbohydrate Drugs

糖类广泛存在于动物、植物及微生物中,结构复杂多样,具有广泛的药理活性,尤其在抗凝血、抗血栓、调血脂、调节免疫功能方面都有显著的疗效。随着对糖类药物研究的日趋深入及现代分析技术的应用,糖类药物化学结构、分子量及分子量分布、有关物质(杂质)等项目的检测得到飞速发展。该文就近年来糖类药物在提取工艺、分离纯化工艺、组成成分,含量分析及结构分析等方面的进展做简要概述,为糖类药物的开发及其质量控制提供一定的参考。

Carbohydrates,with complex and diverse structures,exist widely in animals,plants,and microorganisms.Carbohydrates have a wide range of pharmacological activities,especially in anticoagulation,antithrombotic,blood lipid regulation,and immune function regulation.With the deepening of the research of carbohydrate drugs and the application of modern analytical technology,the detection of chemical structure,molecular weight and molecular weight distribution,and related substances(impurities)of carbohydrate drugs has been developed rapidly.In this paper,the progress of carbohydrate drugs in extraction technology,separation and purification technology,composition analysis,content determination,and structural analysis in recent years was briefly reviewed,which provided some guidance for developing and quality control of carbohydrate drugs.