在溶剂膨胀聚合物中提取动力学的基于物理的模型:使用非详尽的提取来估计可提取量的总量
Robert M Elder1, Kaleb J Duelge1, Nimesh P R Ranasinghe Arachchige1
1Center for Devices and Radiological Health, FDA, Silver Spring, Maryland, USA.
Journal of biomedical materials research. Part B, Applied biomaterials
|December 29, 2025
概括
一个新的自由体积模型估计了使用非详尽的提取方法从医疗器械中初始可漏量 (M0). 这种方法可以解释聚合物胀,并准确预测可漏量,改善患者暴露风险评估.
科学领域:
- 材料科学与工程 材料科学与工程
- 生物医学工程 生物医学工程
- 化学工程是化学工程的重要组成部分.
背景情况:
- 聚合物医疗器械中的可溶性物质通过体内迁移带来潜在的健康风险.
- 准确估计初始可漏量 (M0) 对于基于物理的大众运输模型至关重要.
- 由于动力或热力学限制,对M0的确定进行详尽的提取测试可能是不切实际的.
研究的目的:
- 开发一种新的自由体积模型,用于从非详尽的提取中估计M0.
- 将溶剂膨胀对聚合物矩阵内的溶解物扩散率 (D) 的影响纳入.
- 为改善M0预测提出聚合物/溶剂分区系数 (K) 的极限值.
主要方法:
- 开发了一个自由体积模型,整合了溶剂膨胀对溶液扩散率 (D) 的影响.
- 分析了聚合物/溶剂分区系数,以确定K的极限值.
- 将开发的模型与一个质量运输方程相结合,以预测M0.
主要成果:
- 该模型在预测溶解物扩散率 (D) 和初始可漏量 (M0) 方面表现出数量级的准确性.
- 对实验数据的验证证实了该模型的预测能力.
- 预测的M0值,当在体内暴露模型中使用时,产生了与使用先验M0知识的结果相似的结果.
结论:
- 不详尽的提取可以有效地用于推断聚合物医疗器械的可提取总量.
- 开发的自由体积模型为估计M0提供了一种实用和准确的方法,适用于性聚合物和疏水系统.
- 这种方法可以保守地估计患者暴露在水材料中的情况,从而提高医疗器械安全性评估.
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