重组胶原蛋白创面敷料关键性能及测试研究  

Research Progress for Key Properties and Test Methods of Recombinant Collagen Wound Dressing

作　　者：王晓晨 夏文龙 杨政 柴谦 WANG Xiao-chen;XIA Wen-long;YANG Zheng;CHAI Qian(Shandong Center for Food and Drug Evaluation&Inspection,Shandong Jinan 250014;Jiangsu High-Wit Biotechnology Co.,Ltd.,Jiangsu Nanjing 211500)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014 [2]江苏海智生物医药有限公司,江苏南京211500

出　　处：《中国医疗器械信息》2023年第23期19-22,共4页China Medical Device Information

摘　　要：重组胶原蛋白基于基因优化修饰后的功能特点可制备成第二类重组胶原蛋白创面敷料医疗器械产品,广泛用于创面护理等生物组织工程领域。根据《重组胶原蛋白创面敷料注册审查指导原则》,结合技术审评经验和部分审评案例,从产品不可吸收方法选择和模型设计、物理阻隔层测试方法和效果评价、有效成分鉴别分析、有效成分含量测定的四方面梳理重组胶原蛋白创面敷料的关键性能指标,介绍目前常采用的检验方法,提供一些证明重组胶原蛋白创面敷料安全有效性能的设计方案,归纳分析不同鉴别含量测试方法的优势和缺点。以期为注册申请人提供申报参考,开拓研究思路,为统一各省技术审评人员对重组胶原蛋白创面敷料的审评标准和尺度提供帮助,促进第二类重组胶原蛋白创面敷料产品的高质量健康发展。Based on the functional characteristics of recombinant collagen after gene optimization and modification,recombinant collagen can be prepared into the second type of recombinant collagen wound dressing medical device products,which are widely used in the field of biological tissue engineering such as wound care.In this paper,according to the Guiding Principles for Registration Review of Recombinant Collagen Wound Dressings,combined with technical review experience and some review cases,some key performance indicators of recombinant collagen wound dressings were sorted out from four aspects:nonabsorbable method selection and model design,physical barrier layer test method and effect evaluation,active ingredient identification analysis,and active ingredient content determination.The test methods commonly used at present are introduced,some design schemes to prove the safety and effectiveness of recombinant collagen wound dressings are provided,and the advantages and disadvantages of different identification analysis and content test methods are summarized.This paper provides application reference for registration applicants and opens up research ideas,which is conducive to unifying the evaluation standards and scales of technical reviewers in various provinces for recombinant collagen wound dressings,and promotes the high-quality and healthy development of the second type of recombinant collagen wound dressings.

关 键 词：重组胶原蛋白创面敷料 不可吸收模型 物理阻隔层 成膜 鉴别 含量 

分 类 号：R318.08[医药卫生—生物医学工程]