文章摘要
史建峰,柯林楠,王春仁,李静莉.海洋生物医用材料的临床应用和安全性评价[J].中国药事,2020,34(6):680-686
海洋生物医用材料的临床应用和安全性评价
Clinical Application and Safety Evaluation of Marine Biomedical Materials
投稿时间:2020-02-26  
DOI:10.16153/j.1002-7777.2020.06.010
中文关键词: 海洋生物医用材料  医用材料  物理化学表征  生物学评价
英文关键词: marine biomedical materials  medical materials  physical and chemical characteristics  biocompatibility evaluation
基金项目:中国食品检定研究院中青年发展研究基金(编号2019C4);国家重点研发计划(编号2016YFC1101202)
作者单位E-mail
史建峰 中国食品药品检定研究院, 北京 102629  
柯林楠 中国食品药品检定研究院, 北京 102629  
王春仁 中国食品药品检定研究院, 北京 102629 chunrenwang@263.net 
李静莉 中国食品药品检定研究院, 北京 102629 lijli@nifdc.org.cn 
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中文摘要:
      目的: 对海洋生物医用材料在医疗领域的应用情况和海洋生物材料来源医疗器械的安全性评价趋势进行分析,为推进该材料的临床转化提供参考。方法: 归纳海洋生物医用材料的分类和应用,介绍该材料的安全性评价的程序要点,探讨其安全性评价中面临的挑战。结果与结论: 常用的海洋生物医用材料主要为多糖和蛋白质,在创伤修复和组织工程领域应用广泛。海洋生物医用材料具有生物活性和良好的生物相容性,对此类材料的安全性评价应根据材料特性和预期用途,科学制定评价程序和选择检验方法。
英文摘要:
      Objective: To analyze the medical application status of marine biomedical materials and the safety evaluation trends of medical devices sourced from marine biomedical materials, so as to provide references for their clinical transformation. Methods: The classifications and application of marine biomedical materials were summarised, and the key procedures and challenges encountered in their safety evaluation were disscused. Result and Conclusion: The commonly used marine biomedical materials mainly consist of polysaccharides and proteins, which are widely used in the fields of wound healing and tissue engineering. The marine biomedical materials possess the characteristics of bioactivity and biocompatibility. It was necessary to establish scientific evaluation procedures and test methods according to the properties and intended uses of materials.
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