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可吸收止血材料研究现状与相关技术要求

张世庆 赵雄 鲁景艳 章金刚

军事医学2012,Vol.36Issue(11):862-866,5.
军事医学2012,Vol.36Issue(11):862-866,5.

可吸收止血材料研究现状与相关技术要求

Review on absorbable hemostatic material and its technical requirements

张世庆 1赵雄 2鲁景艳 2章金刚2

作者信息

  • 1. 国家食品药品监督管理局医疗器械技术审评中心,北京,100044
  • 2. 军事医学科学院野战输血研究所,北京,100850
  • 折叠

摘要

Abstract

Absorbable hemostatic materials, are proposed, are the medicals material used for stopping bleeding by accelerating the clotting process of blood, which would be absorbed within a certain period of time by the human body. Some materials are commonly used currently, such as collagen, gelatin, oxidized cellulose and cyanoacrylates. Absorbable hemostatic materials make significant contributions to first-aid and rapid hemostasis, which is one of the hot points in medical industry. However, the development of new products is hindered by complicated components and lack of product standards or guideline. The US FDA is more experienced in evaluating these products for their further development. In this article, we reviewed the development status and technical requirements of absorbable hemostatic materials. We also discussed the general problems with registration.

关键词

可吸收性/止血/美国食品和药物管理局

Key words

absorbability/ hemostasis/ United States Food and Drug Administration

分类

医药卫生

引用本文复制引用

张世庆,赵雄,鲁景艳,章金刚..可吸收止血材料研究现状与相关技术要求[J].军事医学,2012,36(11):862-866,5.

基金项目

北京市自然科学基金资助项目(7123222) (7123222)

军事医学

OA北大核心CSCDCSTPCD

1674-9960

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