动物源性补片产品的研究现状和安全性思考
Research Status and Safety Considerations of Animal-Derived Mesh Products
赵丹妹 1李崇崇 1俞兰 2刘丽 1黄元礼 1柯林楠1
作者信息
- 1. 中国食品药品检定研究院,北京市,102629
- 2. 重庆医疗器械质量检验中心,重庆市,400799
- 折叠
摘要
随着经济发展和技术进步,越来越多的动物源性补片产品应用于组织和器官修复替代的医学领域.动物源性补片由于结构组成和生产工艺的复杂性,其在实际应用中仍存在力学强度不足、降解速率快、有害可沥滤物检出等问题.其中,产品生产工艺是影响产品质量的关键要素.该文重点综述了目前国内动物源性补片的生产工艺和质量控制的关键点,以期为该类产品的质量控制和监督管理提供新思路.
Abstract
With the development of the economy and technological progress,more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement.Owing to the complexity of their structure and production process,these animal-derived meshes still face several challenges in practical applications,such as insufficient mechanical strength,rapid degradation rates,and the detection of harmful leachable substances.Among these challenges,the production process is a key factor affecting product quality.This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China,offering new insights for the quality control and regulatory oversight of such products.
关键词
动物源性补片/生产工艺/质量控制/脱细胞/残留溶剂Key words
animal-derived meshes/production process/quality control/decellularization/residual solvent引用本文复制引用
出版年
2024
NETL
NSTL
万方数据