中国药物警戒 ›› 2014, Vol. 11 ›› Issue (9): 564-566.

• 药械安全性研究 • 上一篇    下一篇

静电纺丝纳米纤维在医用敷料的应用及风险评估

许耘, 邓洁*   

  1. 国家食品药品监督管理总局医疗器械技术审评中心,北京100044
  • 收稿日期:2014-01-24 修回日期:2016-02-03 出版日期:2014-09-08 发布日期:2016-03-02
  • 通讯作者: 邓洁,女,主任药师,医疗器械评价。
  • 作者简介:许耘,女,博士,讲师,医疗器械评价。

Application and Risk Evaluation of Electrospinning Nanofibers in Dressing

XU Yun, DENG Jie*   

  1. Centre for Medical Device Evaluation, CFDA, Beijing 100044, China
  • Received:2014-01-24 Revised:2016-02-03 Online:2014-09-08 Published:2016-03-02

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摘要： 静电纺丝技术是制备连续纳米纤维的一种重要方法,该法所制备纤维的直径在数十纳米到微米之间,该技术已逐渐引入医用敷料的生产过程。由于纳米材料独特的理化特性及生物学特性,其在医疗领域的应用引起了极大的关注。本文就静电纺丝纳米纤维在医用敷料方面的研究进展及其带来的安全风险和控制进行简述,以供大家探讨。

关键词: 医用敷料, 静电纺丝, 纳米纤维, 风险评价

Abstract: Electrospinning is an important method that produces continuous polymer fibers with diameters in the range of nanometer to micrometer, which has been used in the process of medical dressing. Since the special physicochemical and biological features of nanomaterials, many focus has been raised on the usage in medical area. We discussed the progress of medical dressing made with electrospinning and the risk management thereof.

Key words: dressing, electrospinning, nanofibers, risk evaluation

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