固态胶原基材料在医疗器械中的应用  

Application of solid collagen-based materials in medical devices

作　　者：胡张捷 张宝贯 张智武 Hu Zhangjie;Zhang Baoguan;Zhang Zhiwu(Zhejiang Chumsun Biological Products Co.,Ltd.,Hangzhou 311100,Zhejiang Province,China;Shanghai Guangming Middle School,Shanghai 200021,China)

机构地区：[1]浙江崇山生物制品有限公司,浙江省杭州市311100 [2]上海市光明中学,上海市200021

出　　处：《中国组织工程研究》2025年第16期3503-3512,共10页Chinese Journal of Tissue Engineering Research

摘　　要：背景:胶原蛋白是细胞外基质的主要构成成分,具有稳定的三螺旋结构特性、良好的生物学特性和可加工性,是一种理想的生物医用材料,已被广泛应用于医疗器械领域。目的:分析固态胶原基材料的主要产品形态、技术特点、制备工艺和临床应用。方法:应用计算机检索PubMed和中国知网数据库收录的有关固态胶原基材料在医疗器械领域应用的研究,英文检索词为“collagen,collagen sponge,collagen membrane,collagen powder,collagen gel,decellularized extracellular martix,medical device,clinical application”,中文检索词为“胶原,胶原海绵,胶原膜,胶原粉,胶原凝胶,脱细胞基质,医疗器械,临床应用”。根据纳入与排除标准对所有文章进行初筛后,保留质量和相关性较高的92篇文献进行综述。结果与结论:以动物源来源固态胶原基材料作为医疗器械制备材料,已在原料提取、制备工艺及临床应用等方面取得显著进展,海洋生物胶原和重组胶原增加了胶原来源的可选择性。固态胶原基医疗器械产品类型丰富,制备方法多样,其中交联改性是提升材料性能的重要途径,值得被深入研究。在产品开发思路上,固态胶原基医疗器械产品研究正朝着立体化和仿生化方向发展,与其他生物材料、药物复合的研究也展现出巨大潜力。尽管国内已有不少胶原基医疗器械应用于临床,但在人工皮肤、软骨修复和神经损伤修复等领域的产品开发仍显不足,需在技术和产业化上进一步突破与创新。BACKGROUND:Collagen is the main component of extracellular matrix.With its stable triple helix structure,good biological characteristics and machinability,collagen is an ideal biomedical material and has been widely used in the field of medical devices.OBJECTIVE:To analyze the main product morphology,technical characteristics,preparation process,and clinical application of solid collagen-based materials.METHODS:The research on solid collagen-based materials in the field of medical devices included in PubMed and CNKI was searched by computer.The English and Chinese search terms were“collagen,collagen sponge,collagen membrane,collagen powder,collagen gel,decellularized extracellular martix,medical device,clinical application.”After preliminary screening of all articles according to inclusion and exclusion criteria,92 articles with higher quality and relevance were retained for review.RESULTS AND CONCLUSION:Solid collagen-based materials from animal sources have been used as materials for the preparation of medical devices,and remarkable progress has been made in raw material extraction,preparation technology,and clinical application.Marine biological collagen and recombinant collagen have increased the selectivity of collagen sources.There are various types of solid collagen-based medical devices and various preparation methods,among which crosslinking modification is an important way to improve material properties,which is worthy of further study.In terms of product development ideas,research on solid collagen-based medical device products is developing in the direction of trivialization and biochemistry,and the research on compounding with other biological materials and drugs has also shown great potential.Although many collagen-based medical devices have been used clinically in China,product development in the fields of artificial skin,cartilage repair,and nerve injury repair is still insufficient,and further breakthroughs and innovations in technology and industrialization are needed.

关 键 词：胶原蛋白 固态胶原 生物学特性 医疗器械 制备工艺 临床应用 

分 类 号：R459.9[医药卫生—治疗学] R318.08[医药卫生—临床医学] R-1