胶原蛋白医疗器械产品的质量评价研究现状  

Research status of quality evaluation of collagen medical device products

作　　者：刘璟 刘子琪 陈卓颖 丁黎[2] 付步芳[1] LIU Jing;LIU Ziqi;CHEN Zhuoying;DING Li;FU Bufang(National Institutes for Food and Drug Control,Beijing102629;China Pharmaceutical University,Nanjing211198;South China University of Technology,Guangzhou 510641)

机构地区：[1]中国食品药品检定研究院,102629 [2]中国药科大学,南京211198 [3]华南理工大学,广州510641

出　　处：《北京生物医学工程》2024年第3期320-326,共7页Beijing Biomedical Engineering

基　　金：国家重点研发计划(2017YFC1105000)资助。

摘　　要：胶原蛋白(collagen)是结缔组织中主要的一种结构性蛋白,具有良好的生物相容性和生物可降解性,胶原蛋白相关产品的研发是国内外相关领域的研究热点之一。总结概括胶原蛋白产品的质量和安全相关的检测和评价方法,对于胶原蛋白医疗器械产品质量控制具有重要的意义。本文首先回顾胶原蛋白应用与标准化现状,介绍代表性医疗器械产品胶原蛋白植入剂和常用于止血和促进创面愈合的敷料类产品,并对相关产品的标准化研究现状进行概括。其次,重点阐述胶原蛋白的质量评价研究,主要介绍胶原蛋白的类型和鉴别、蛋白质含量分析和重金属检测等关键指标。其中,通过对氨基酸和三螺旋结构的分析能够进一步实现对胶原蛋白的鉴别,分别对杂蛋白、胶原蛋白和总蛋白的含量分析则可实现对相关胶原蛋白产品中蛋白质含量的全面分析。最后对胶原蛋白领域的研究和质量评价现状进行概括,并对其未来发展进行展望。胶原蛋白作为应用广泛的生物材料,应不断完善其评价技术和方法,提升相关质量评价标准,才能促进胶原蛋白相关产业的健康发展。Collagen is a major structural protein in connective tissue,which has great biocompatibility and biodegradability.In worldwide,the research and development of collagen-related products has become a hotspots.Summarizing the quality and safety detection and evaluation methods is important for the quality control of collagen-related medical devices and products.Firstly,this paper reviewes the application and standardization of collagen.It introduces representative medical device products,such as collagen implants and dressing for hemostasis and healing promotion and,and summarizes the related standardization.Sencondly,focuses on the quality evaluation of collagen,mainly introduces the key indicators such as the type and identification of collagen,protein content analysis and heavy metal detection.The analysis of amino acids and triple helix structures can help identify collagen,and the separate analysis of impurity protein,collagen protein and total protein content can be comprehensive analysis of protein content in collagen products.Finally,this paper summarizes the research and quality evaluation status of collagen,and prospectes the future development.As a widely used biomaterial,the evaluation methods and the quality control criteria of collagen should be enhanced continuously in order to promote the development of related industries.

关 键 词：胶原蛋白 医疗器械 质量评价 标准化 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]