创面组织再生修复材料的安全性和有效性评价技术研究进展

Progress of safety and effectiveness evaluation technology of materials for wound tissue regeneration and repair

新型组织再生修复生物材料具有促进创面细胞增生和迁移,加速创面愈合速度和提高创面愈合质量的作用。随着这类新型材料的不断涌现,传统的评价方法和技术在一定程度上已经不完全适用,因此就新型创面再生修复材料的表征以及生物安全性和有效性评价的最新研究进展进行了总结。介绍了这类材料的化学性能、降解吸收、物理性能以及生物相容性评价要求,重点综述了新建立的有效评价技术,包括体外细胞增殖、细胞迁移、体外屏蔽保护、微血管形成试验,以及体内动物创伤模型的建立和创面愈合有效性评价方法。

Newly developed biomedical materials for tissue regeneration and repair can promote cell proliferation and immigration in wounds,accelerate wound healing,and enhance healing quality.With the development of these new materials,the traditional evaluation method and technology are no longer completely applicable.Therefore,the recent progress of research on characterization,biosafety,and effectiveness evaluation of newly developed materials for wound tissue regeneration and repair was summarized.The chemical property,degradation and absorption,physical property,and biocompatibility evaluation requirement of the materials were introduced,and the established effectiveness evaluation technology was described,including in vitro cell proliferation,cell immigration,in vitro barrier protection,and microangiogenesis tests,as well as in vivo animal wound modeling and wound healing effectiveness evaluation method.