低分子量肝素一致性评价技术研究概况

Overview of the Research on Consistency Evaluation Technology of Low Molecular Weight Heparin

低分子量肝素是一类结构复杂的多组分糖胺聚糖类药物,在抗凝血、抗血栓、抗炎等领域有广泛的应用。本文对低分子量肝素产品一致性评价进展情况进行阶段性总结,并依据相关指南、文献等资料回顾了低分子量肝素一致性技术研究现状。重点从理化性质的一致性、体内外活性一致性、低分子量肝素杂质概况、免疫原性风险评估等低分子量肝素一致性重点研究项目和包材相容性等常规研究项目进行介绍。相关技术探讨与展望对提高国产低分子量肝素产品质量,提高我国肝素产业竞争力具有重要意义。

Low molecular weight heparin is a kind of multicomponent glycosaminoglycan drugs with a complex structure, which is widely used in the fields of anticoagulant, antithrombotic, anti-inflammatory and so on. This paper reviews the progress of consistency evaluation of low molecular weight heparin products and the research status on consistency evaluation technology of low molecular weight heparin referring to technical guidelines and literatures. This study focuses on the key researches on consistency of low molecular weight heparin and routine researches such as compatibility of packaging materials, mainly including consistency of physical and chemical properties, in vitro and in vivo activity, impurity profile, immunogenicity risk assessment and so on. The discussion and prospect of related technologies are of great significance to improve the quality of domestic low molecular weight heparin products and enhance the competitiveness of China’s heparin industry chain.