在线静脉输液过器的蛋白质吸附和相应的缓解计划
Xing Mu1, Yao Tang1, Hangting Hu1
1WuXi Biologics, 190 Hedan Road, Waigaoqiao Free Trade Zone, Shanghai 200131, China.
Journal of pharmaceutical sciences
|May 20, 2025
概括
蛋白质吸附在线过器中减少了静脉注射期间药物回收. 像调整pH值,使用充电过器,添加电解质或聚酸80等表面活性剂等策略可以最大限度地减少蛋白质损失.
科学领域:
- 生物制药科学 生物制药科学
- 材料科学是一种材料科学.
- 药物输送是药物输送的过程.
背景情况:
- 医疗器械的蛋白质吸附是静脉注射 (IV) 治疗的一个重大挑战,影响药物的疗效.
- 在线过器是蛋白质吸附的主要部位,因为它们的多孔结构和表面特性.
研究的目的:
- 在静脉注射期间,研究蛋白质吸附机制在线过器上.
- 评估减轻吸附引起的蛋白质损失的策略.
主要方法:
- 在乳糖 (D5W) 和盐溶液中评估了四种具有不同异电点 (pI) 和疏水性的蛋白质的吸附.
- 评估了溶液pH,过器电荷,电解质添加和表面活性剂 (聚酸盐80) 对蛋白质吸附的影响.
主要成果:
- 与输液袋和输液线相比,直线过器造成的蛋白质损失最为显著.
- 在D5W中吸附主要是由于静电相互作用,通过pH调整,充电过器或电解质减少.
- 疏水性相互作用主导了盐水中的蛋白质吸附,特别是对于疏水性蛋白质.
- 聚酸盐80 (0.005%) 在所有测试的蛋白质中几乎实现了100%的剂量恢复.
结论:
- 蛋白质吸附受静电和疏水相互作用的影响,这取决于稀释剂和蛋白质的特性.
- 缓解策略,包括添加表面活性剂,可以有效地防止IV输液期间的蛋白质损失.
- 决策树有助于根据特定条件选择适当的方法来减少蛋白质吸附.
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