用于过敏治疗的聚烯注射器中Paclitaxel的物理化学稳定性研究
J Sorrieul1, F Nicolle1, J Robert1
1Pharmacy, Institut de Cancérologie de l'Ouest Paul Papin, 15 rue Boquel, 49055 Angers, France.
Annales pharmaceutiques francaises
|February 21, 2026
概括
帕克利塔塞尔在冷藏时,在用于过敏测试的聚烯注射器中是稳定的. 适当的储存对于防止降解至关重要,特别是在更高的温度下,确保在瘤学中安全的临床使用.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 临床药房 临床药房
背景情况:
- 帕克利塔塞尔是一种重要的化疗剂,可在约10%的患者中引起过敏反应 (HSR).
- 管理HSR通常涉及过敏学测试,但缺乏关于这些测试的注射器中paclitaxel稳定性的数据.
研究的目的:
- 为了评估在聚烯注射器中低度的帕克利塔塞尔的物理化学稳定性.
- 为了确定预先准备的帕克利塔塞尔溶液的最佳储存条件,用于过敏学测试.
主要方法:
- 开发并验证了一种稳定性指示的UPLC-DAD方法.
- 评估了帕克利塔塞尔在0.9%NaCl中的稳定性 (0.006-0.6毫克/毫升) 在聚烯注射器中在-20°C,5°C,25°C和40°C下持续28天.
- 监测化学稳定性 (降解产品) 和物理稳定性 (pH,颜色,度,降水).
主要成果:
- 在所有测试度中,paclitaxel 在5°C和25°C下在28天内保持化学稳定.
- 化学降解发生在40°C.
- 在40°C (6日) 和25°C/5°C (21日) 观察到物理不稳定性 (降水,度),特别是在较稀释的溶液中.
- 化学和物理稳定性在-20°C下维持了28天.
结论:
- 帕克利塔塞尔可以预制并存储在低度的聚烯注射器中,在冷藏条件下 (5°C) 用于过敏学用途.
- 严格遵守储存准则是防止化学和物理降解的必要条件,特别是在高温下.
- 研究结果支持高效的医院工作流程来管理瘤病人的HSR.
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