在生理条件下的尼丁醇释放:表面氧化物,pH,过氧化和二酸盐的影响
Eric M Sussman1, Huiyu Shi2, Paul A Turner1
1Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, USA.
概括
从尼丁醇医疗器械中释放的在生理pH和活性氧物种 (ROS) 条件下增加. 了解设备-组织接口的化学环境对于预测离子释放至关重要.
科学领域:
- 生物材料科学 生物材料科学
- 材料科学 材料科学 材料科学
- 医疗设备工程 医疗设备工程
背景情况:
- 尼醇 (合金) 由于其独特的特性,对医疗器械至关重要.
- 从尼醇中释放的是一种担忧,受表面表面和制造工艺的影响.
- 现有有限的工具可以评估生理条件下的释放,如变化的pH值和活性氧物种 (ROS).
研究的目的:
- 为了量化尼铁离子从不同表面的尼醇线释放量.
- 在模拟生理学pH和ROS度下评估释放.
- 为了研究炎症条件对尼丁醇释放的影响.
主要方法:
- 具有不同表面成型的尼丁醇电线被暴露在受控的pH水平下.
- 在不同度的活性氧物种 (ROS),包括过氧化和NaOCl/HOCl中测量了释放.
- 实验条件的设计是为了模仿和超过报告的生理外细胞pH和ROS水平.
主要成果:
- 在生理 pH 和 ROS 条件下,从尼醇中释放的显著增加.
- 降低pH值对离子释放的增加有明显的影响.
- 过氧化和NaOCl/HOCl度的增加与释放的增加有关.
结论:
- 植入部位的化学环境极大地影响了尼丁醇设备中的释放.
- 准确预测释放需要考虑当地的pH和ROS水平.
- 对设备-组织接口化学的进一步研究对于尼丁醇医疗器械安全至关重要.
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