文章摘要
海洋生物医用材料的临床应用和安全性评价
An investigation on clinical application and safety evaluation of marine biomedical materials
投稿时间:2020-02-26  修订日期:2020-05-26
DOI:
中文关键词: 海洋生物材料,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 characterization  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)
作者单位邮编
史建峰 中国食品药品检定研究院 102629
柯林楠 中国食品药品检定研究院 
王春仁 中国食品药品检定研究院 
李静莉* 中国食品药品检定研究院 102629
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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 review and analyze the medical application, biosafety evaluation and future trend of marine biomedical materials. This study was conducted to provide references for translating to clinic. Methods: The information of marine biomedical materials was collected, including classifications and application of those biomaterials, the key procedures and challenges of safety evaluation were also introduced and demonstrated. Result and Conclusion: The commonly used marine biomedical materials are mainly 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 the properties and intended use of materials.
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