使用超高性能液态染色体-并列质谱测量,对共组织和骨中的万科米辛和克林达米辛的量化
Amanda J Holst1, Soma Bahmany1, Angela C J van Dorp1
1Department of Hospital Pharmacy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Therapeutic drug monitoring
|September 5, 2025
概括
一种新的方法可以准确地测量手术后骨和关节组织中的万科米辛和克林达米辛. 这有助于优化周围假肢关节感染 (PJIs) 的抗生素剂量.
科学领域:
- 分析化学
- 药物动力学
- 骨科手术
背景情况:
- 在接受关节或膝关节整形手术的患者中,周围假肢关节感染 (PJIs) 占1-2%.
- 目前的PJI治疗依赖于修复手术和长时间的抗生素治疗.
- 感染部位的抗生素度可能导致治疗失败或不良反应.
研究的目的:
- 开发和验证一种新的超高性能液体染色体-双重质谱法 (UHPLC-MS/MS) 方法.
- 在突组织和骨样本中量化范胺和克林达胺度.
- 为了更好地了解PJI治疗中的抗生素药动力学.
主要方法:
- 开发一种UHPLC-MS/MS技术用于抗生素量化.
- 方法验证符合欧洲药物管理局 (EMA) 和美国食品和药物管理局 (FDA) 的指导方针.
- 测试抗生素提取物的线性,精度,准确性和稳定性.
主要成果:
- 通过UHPLC-MS/MS方法在骨和突组织中证明了万科米辛和克林达米辛的优异线性 (r2 > 0. 990).
- 精度,准确性和转移的验证参数处于可接受的范围内.
- 克林达米辛提取物在24小时内稳定;万科米辛提取物在突组织中稳定,但在骨中不稳定.
结论:
- 已成功开发了一种经过验证的UHPLC-MS/MS方法,用于在突组织和骨中量化范胺素.
- 这种方法为PJI的药理动力学研究提供了至关重要的工具.
- 这些组织度测量可以为优化抗生素剂量策略提供信息.
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