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用重新包装机使用剂量管理辅助器重新包装的克洛沙平片的稳定性
Marion Emonet1, Antony Citterio-Quentin2, Sandrine Bourgeois3
1Pharmacy Department, The Vinatier Hospital, Bron, France.
重新包装的克洛沙片在84天内保持化学稳定,符合质量均性标准. 然而,物理测试显示裂纹和硬度降低,导致84天的保质期.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 制定 发展 制定 发展
背景情况:
- 重包装用于自动发药的药物可能会影响药物的稳定性.
- 制造商的原始包装是稳定性评估的标准.
研究的目的:
- 为了评估重新包装的克洛扎片的物理和化学稳定性.
- 在医院药房设置中确定重新包装的克洛扎宾的合适保质期.
主要方法:
- 克洛扎100毫克片被重新包装,并在各种条件下储存了84天.
- 进行了物理测试 (外观,质量均性,易碎性,硬度) 和化学稳定性 (UHPLC-MS/MS).
- 结果与原包装中的对照片进行了比较.
主要成果:
- 没有观察到显著的化学降解或N-desmethyl-clozapine的形成.
- 质量均性得到维持,但平板显示在易碎性测试中出现裂,硬度降低.
- 视觉变化只发生在紫外线照射下.
结论:
- 重新包装的克洛沙平片表现出 84 天的良好化学稳定性.
- 物理完整性,特别是药片的硬度和易碎性,在重新包装后受到损害.
- 基于这些发现,重新包装的克洛扎片的保质期为84天.
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