在口服液样本中评估抗药物的稳定性
João Martinho1,2, Ana Y Simão1,2, Tiago Rosado1,2,3
1RISE-Health, Departamento de Ciências Médicas, Faculdade de Ciências da Saúde, Universidade da Beira Interior, Av. Infante D. Henrique, 6200-506 Covilhã, Portugal.
Pharmaceuticals (Basel, Switzerland)
|July 30, 2025
概括
对抗药物的干唾液点 (DSS) 分析为治疗药物监测 (TDM) 提供了一种稳定,非侵入性的方法. 最佳的储存包括在黑暗中用甲酸制冷,以确保临床使用药物的稳定性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 分析化学 分析化学
- 临床诊断 临床诊断 临床诊断
背景情况:
- 影响全球5000万,抗药物 (AED) 是主要治疗方法.
- 由于治疗窗口狭窄,治疗药物监测 (TDM) 对AED至关重要.
- 口服液是TDM的一个有前途的替代基因,提供适合不同人群的非侵入性采集.
研究的目的:
- 在干唾液点 (DSS) 样本中评估四种常见的AED的稳定性 (费诺巴尔比他,芬伊托因,碳胺,碳胺-10,11-环氧化物).
- 确定最佳的储存条件,以长时间保持AED分析物的完整性.
- 评估防腐剂,温度,光线和持续时间对口服液中AED稳定性的影响.
主要方法:
- 采集了含有AED的口腔液体样本,并将其作为DSS存储.
- 使用二极管阵列检测 (HPLC-DAD) 的高性能液态色谱进行量化.
- 实验设计 (DOE) 工具系统地评估影响分析物的稳定性的因素.
主要成果:
- 在黑暗中冷藏下,以低度的 Askorbic 酸作为防腐剂实现了最佳稳定性.
- 与没有防腐剂或之前报告的数据的样本相比,10μg/mL的样本的稳定性延长了14天.
- 一个意想不到的发现是,在没有防腐剂的样本中,在0.5μg/mL时分析物的稳定性更高.
结论:
- 这项研究是首次将DSS采集与HPLC-DAD结合起来,以评估AED在口服液中的稳定性.
- 这些发现支持了基于唾液的TDM对AED的可行性,为非侵入性监测策略提供了有价值的见解.
- 优化的储存条件提高了用于药物的临床TDM的DSS的可靠性.
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