多糖类抗血栓药物舒洛地特与低分子肝素的多方位比较分析  

Multi-dimensional Comparison between Sulodexide and Low Molecular Weight Heparin of Polysaccharide Antithrombotic Drugs

作　　者：吴朝阳[1] 李湛军[1] 董武军 Wu Zhaoyang;Li Zhanjun;Dong Wujun(National Institutes for Food and Drug Control,Beijing 102629,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国药事》2023年第7期817-824,共8页Chinese Pharmaceutical Affairs

基　　金：2023年中国食品药品检定研究院学科带头人培养基金(编号2023X7);北京市自然科学基金(编号7194337)。

摘　　要：目的:舒洛地特与低分子肝素都是多糖类抗血栓药物,多方位比较二者的异同,对监管提出建议。方法:从构效关系入手,探讨质控基本要求,对作用机理、临床应用、不良反应等多方位进行全面梳理并比较二者的抗凝、抗血栓强度及临床应用价值。结果与结论:舒洛地特与低分子肝素作为抗血栓药物,二者抗血栓作用相当,抗凝作用舒洛地特比低分子肝素强,并且无出血风险。由于多组分多糖类药物质量控制难度较大,本文提出对原料药和制剂的监管需要从起始物料源头开始,参照生物类似药进行生产全过程质量控制,以保证多糖类药物的质量稳定、安全有效。Objective:To compare the similarities and differences between sulodipine and low molecular weight heparin from multiple perspectives,both of which are polysaccharide antithrombotic drugs,and to provide recommendations for regulation.Methods:Starting from the structure-activity relationship,we explored the basic requirements for quality control,comprehensively sorted out the mechanism of action,clinical application,adverse reactions,and other aspects,and compared the anticoagulation,antithrombotic strength,and clinical application value of the two.Results and Conclusion:As antithrombotic drugs,sulodexide and low molecular weight heparin have similar antithrombotic effects.The anticoagulant effect of sulodexide is stronger than that of low molecular weight heparin,and there is no risk of bleeding.Due to the diffi culty in quality control of multicomponent polysaccharide drugs,this article proposes that the supervision of APIs and preparations should start from the source of starting materials,and refer to the entire production process quality control of biosimilars to ensure the stability,safety and effectiveness of the quality of polysaccharide drugs.

关 键 词：舒洛地特 低分子肝素 抗凝 抗血栓 质量控制 

分 类 号：R97[医药卫生—药品]