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

可吸收止血材料是指应用于伤口出血部位,通过加速血液凝固过程达到止血目的,在一定时间内能被人体吸收的医用材料。常见的可吸收止血材料有胶原、明胶、氧化纤维素、氰基丙烯酸类组织胶等。可吸收止血材料对于创伤急救和快速止血具有重要意义,是目前医疗行业关注的热点之一。然而,由于这类产品组成复杂,国内缺乏相关的产品标准和上市指导原则,在一定程度上限制了新产品的研发上市。美国FDA发展历程较长,对可吸收止血材料的技术要求相对完善。本文就可吸收止血材料的研发现状、美国FDA的技术要求及当前注册申报中的常见问题进行了简述。

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 hemo- static materials make significant contributions to first-aid and rapid hemostasis, which is one of the hot points in medical in- dustry. 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 gen- eral problems with registration.