克罗纳泽帕姆2.5 mg/mL口服溶液和1 mg/mL腹腔溶液在预填充的聚烯注射器中的稳定性研究
Juan Carlos Ruiz Ramirez1,2,3, Icram Talsi Hamdani1, Laura Bermúdez Gazquez1
1Deparment of Pharmacology, Faculty of Pharmacy, University of Murcia, 30003 Murcia, Spain.
Pharmaceutics
|October 29, 2025
概括
在预填聚烯注射器中重新包装的克罗纳泽帕姆在30天内保持稳定. 这种方法减少了医疗保健工作者对这种危险药物的暴露,提高了在施用期间的安全性.
科学领域:
- 制药科学 制药科学
- 药物稳定性研究 药物稳定性研究
- 职业健康与安全 职业健康与安全
背景情况:
- 克罗纳泽帕姆是一种抗发作药,被列为危险药物,需要特别的预防措施.
- 目前在玻璃容器中的包装在处理和管理过程中存在风险.
- 将其重新包装成预填充的聚烯注射器可能会提高医疗保健人员的施用安全性.
研究的目的:
- 评估重新包装在预填聚烯注射器中的克罗纳泽帕姆口服和肠道溶液的物理化学稳定性.
- 确定各种储存条件对这些注射器中克洛纳泽帕姆稳定性的影响.
主要方法:
- 一种经过验证的高性能液态染色学 (HPLC) 方法被用于量化克洛纳泽.
- 在不同的储存条件下 (冷藏,室温,暴露于光线) 评估了30天的稳定性.
- 通过监测视觉外观,pH值和晶体形成来评估物理稳定性.
主要成果:
- 在30天后,在所有测试条件下,克罗纳泽帕姆降解率低于10%.
- 没有观察到视觉外观,pH值或晶体形成的显著变化.
- 该药物在预填聚烯注射器中表现出良好的物理化学稳定性.
结论:
- 克罗纳泽帕姆口服 (2.5 mg/mL) 和肠道 (1 mg/mL) 溶液在预填聚烯注射器中稳定长达30天.
- 药房服务中的集中重新包装,使用封闭系统,尽量减少护理人员的操纵.
- 这种重新包装策略有效地减少了与克洛纳泽帕姆等危险药物相关的职业暴露风险.
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