用于皮肤测试的聚烯注射器中储存的5%葡萄糖中的碳烯溶液的物理化学稳定性
Auriane Blanchet1, Solène Loyau1, Julien Robert1
1Institut de Cancérologie de l'Ouest (ICO), 15, rue André-Boquel, 49055 Angers, France.
Annales pharmaceutiques francaises
|October 30, 2025
概括
在5%葡萄糖中高度稀释的碳烯溶液在冷藏和室温下在聚烯注射器中稳定28天. 这种稳定性支持预先准备临床使用.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 分析化学 分析化学
背景情况:
- 碳白是一种重要的化疗剂.
- 了解稀释碳烯的稳定性对于安全有效的临床应用至关重要.
- 稀释的药物配方需要严格的稳定性评估.
研究的目的:
- 为了评估高度稀释的碳烯溶液的物理化学稳定性.
- 评估卡博普拉丁在5%葡萄糖中在不同温度 (5°C和25°C) 的稳定性.
- 为了确定聚烯注射器中碳烯的保质期.
主要方法:
- 稳定性研究遵循国际协调理事会的指导方针.
- 碳酸稀释剂是以无菌方式制备的,并被保护免受光线影响而存储.
- 超高性能液态染色学 (UHPLC) 用于28天的度监测.
- 进行了物理参数和强制降解研究.
主要成果:
- 碳白金溶液保持超过95%的初始度28天.
- 在测试条件下没有检测到任何显著的降解产品.
- 没有观察到物理特征 (颜色,清晰度,pH) 的显著变化.
结论:
- 5% 葡萄糖中的碳烯在聚烯注射器中至少在 28 天内是化学和物理稳定的.
- 在冷藏 (5°C) 和室温 (25°C) 两种存储是可行的,当保护免受光线.
- 这些发现支持提前制备稀释碳烯,可能改善药房运营.
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