咖啡因酸盐在化和葡萄糖溶液中的静脉稀释的稳定性
Grzegorz Szynkaruk1, Marta Puchalska2, Julia Kerner1
1The Student Scientific Society, Poznan University of Medical Sciences, Poznań, Poland.
European journal of hospital pharmacy : science and practice
|December 9, 2025
概括
盐水或葡萄糖中的咖啡因酸盐溶液在室温下稳定48小时,符合关键稳定性标准. 冷藏溶液在24小时后显示出与最严格的USP标准的微小偏差.
科学领域:
- 新生儿药理学 新生儿药理学
- 药物稳定性 药物稳定性
- 密集护理医学是密集护理的医学.
背景情况:
- 咖啡因酸盐对于管理新生儿重症监护室中早产性呼吸暂停至关重要.
- 精确的咖啡因酸盐剂量需要在早产婴儿的静脉注射液中进行各种稀释.
- 评估这些稀释的稳定性对于安全有效的治疗至关重要.
研究的目的:
- 为了评估咖啡因酸盐溶液的化学稳定性.
- 在1 mg/mL和12.5 mg/mL度下评估稳定性.
- 为了确定0.9%的化和5%的葡萄糖溶液在室温和8°C下保存长达48小时的稳定性.
主要方法:
- 使用紫外线检测 (HPLC-UV) 的高性能液态色谱用于度测量.
- 溶液在22°C (室温) 和8°C (冷藏) 的温度下存储.
- 根据国际协调委员会 (ICH) M10和美国药典 (USP) 标准评估稳定性.
主要成果:
- 所有的咖啡因酸盐溶液都符合ICH M10稳定性标准 (±15%).
- 大多数样本也符合更严格的USP标准 (±10%).
- 三个特定样本 (12.5 mg/mL在盐液中24小时冷藏;1 mg/mL在葡萄糖中24小时和48小时冷藏) 超过了USP +10%的限制.
结论:
- 咖啡因酸盐在0.9%的化或5%的葡萄糖中在室温下化学稳定48小时,符合ICH和USP标准.
- 冷藏的咖啡因酸盐溶液 (8°C) 在24小时内始终不符合USP ±10%的标准.
- 这些发现支持在研究参数范围内使用室温储存用于准备的咖啡因酸盐输注.
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