案例信息

标题：海洋聚多糖止血材料（植入类医疗器械）的生物安全性评价

【专业学位类别】公共卫生

【专业领域/方向】转化医学，卫生毒理学

【作者】许零 教授

【单位】厦门大学公共卫生学院

【关键词】海洋聚多糖、止血材料、生物安全性、转化医学

【适用课程】现代公共卫生研究实例，生物制品学，转化医学选论

【版权说明】真实性案例，仅用于教学目的

【案例摘要】

海洋生物多糖具有止血、抑菌、愈创、镇痛、减少疤痕增生等多种生物学功能，广泛应用于可降解吸收的生物医用止血材料等研究中。本案例融合海洋生物学、化学、材料学等各学科力量，对海洋生物多糖等活性物质通过产学研用相结合的方式，进行研发和推广实用创新的高值化生物医药产品。通过解读该过程的关键环节生物安全性评价，使学生掌握植入类医疗器械的生物安全性评价，熟悉科研成果从实验室走向产业化的“概念验证、实验室小试”两个阶段，了解方案的设计与实施，培养学生科技成果转化应用研究的能力。

Tittle: Biosafety evaluation of Marine polypolysaccharide hemostatic materials (implantable medical devices)

Professional Degree Category: Master of Public Health

Specialized fields: Translational medicine, Health toxicology

Authors: Xu Ling

Affiliation: School of Public Health, Xiamen University, Translational medicine

Key words: Marine Polypolysaccharides, Hemostatic Materials, Biosafety, Translational Medicine

Abstract

Marine biological polysaccharide has many biological functions, such as hemostasis, bacteriostasis, guaixing, analgesia, reducing scar hyperplasia, etc.. Marine biological polysaccharide is widely used in the research of biodegradable and absorbable biomedical hemostasis materials. This case integrates the forces of Marine biology, chemistry, materials science and other disciplines to develop and promote practical and innovative high-value biomedical products by combining the production, study, research and application of Marine biological polysaccharides and other active substances. By interpreting the biosafety evaluation of the key link in the process, students can master the biosafety evaluation of implantable medical devices, get familiar with the two stages of "proof of concept and laboratory trial" when scientific research results move from laboratory to industrialization, understand the design and implementation of the program and cultivate students' ability to transform and apply research of scientific and technological achievements.

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