动物源性医疗器械精准风险评价的关键技术研究  

The Critical Techniques Research in Accurate Risk Evaluation of Animal Tissue-Derived Medical Devices

作　　者：徐丽明[1] 邵安良[1] 陈亮[1] 魏利娜[1] 段晓杰[1] Xu Liming;Shao Anliang;Chen Liang;Wei Lina;Duan Xiaojie(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药事》2019年第12期1348-1355,共8页Chinese Pharmaceutical Affairs

基　　金：国家科技重点研发计划(编号2016YFC1103200):生物源性材料及产品的检测与评价关键技术和标准化研究(2016-2020);再生型医用植入器械国家工程实验室首席专家项目(编号2012NELRMD002)获奖项目

摘　　要：目的:动物源性医疗器械的主要安全风险是外源因子污染和不可预测的免疫学及毒理学反应。本文概述最新动物源性医疗器械的精准风险评价关键技术,为相关产品研发和注册审评提供参考,为科学监管提供技术支持。方法:总结自主研发的针对动物源性医疗器械安全风险和质量控制的检测与评价关键技术、方法、标准,以及免疫毒理学评价的几点专家共识。结果和结论:动物源性生物材料DNA残留量测定、残留α-Gal抗原检测方法及标准已发布实施;研究建立了淋巴细胞增殖试验、采用Gal抗原缺失小鼠的免疫学评价方法等免疫毒理学评价技术手段。部分检测项目被《动物源性医疗器械注册技术审查指导原则》(2017修订版)收录。这些技术为动物源性医疗器械的精准风险评价和风险控制提供了技术支持。同时,作者展望了正在研究的风险评价新技术,提出了系统的精准风险评价体系仍需不断完善。Objective: The main safety risks of animal tissue-derived medical devices are contamination and transmission of adventitious agents and undesirable immunological or toxicological responses. Therefore, this review summarizes critical techniques for accurate risk assessment of animal tissue-derived medical devices, and provides support for related product development and registration evaluation that provides technical support for scientific supervision. Methods: A series of critical techniques, methods, standards and strategies used for risk assessments and quality control of animal tissue-derived medical devices developed by the author’s team were summarized, and some points of expert consensus on immunotoxicology evaluation in animal experiments were demonstrated. Results and conclusion: The methods and standards for the determination of DNA remnants and residual α-Gal antigens in animal tissue-derived biological materials were published and implemented;the results from the studies on the establishment of lymphocyte proliferation tests and the use of Gal antigen deficient mice on immunology evaluation provided immunotoxicological evaluation techniques and strategies. Some of the testing items were included in the "Guidelines for the Technical Review of Registration of Animal TissueDerived Medical Devices"(2017, Revised Edition). These technologies provided technical support for accurate risk assessment and control of animal tissue-derived medical devices. At the same time, the author looks forward to the new risk assessment technologies in the research, and proposes that the systematic accurate risk evaluation system still be improved.

关 键 词：动物源性医疗器械 安全风险 精准 风险评价 外源因子 免疫学反应 

分 类 号：R197.39[医药卫生—卫生事业管理] TH77[医药卫生—公共卫生与预防医学]