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沙特阿拉伯部分过期特定药品的质量评估

Quality assessment of some specific drug products beyond expiration dates in Saudi Arabia.

作者信息

Aljohar Haya, Altoum Ghadah H, Alkarni Shahad A, Alburaidi Modhi M, Alhabardi Samiah

机构信息

Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.

Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.

出版信息

Saudi Pharm J. 2025 May 13;33(3):9. doi: 10.1007/s44446-025-00016-4.

Abstract

This study investigates the stability of expired emergency medications, dopamine, dexamethasone, naloxone, epinephrine, and dobutamine, beyond their labeled expiration dates in Saudi Arabia. The research addresses a critical issue in healthcare, where short shelf lives lead to substantial medication waste and financial losses. Using validated HPLC methods compliant with USP and BP guidelines, we analyzed the active pharmaceutical ingredient (API) content of these medications post-expiry. Our methodology involved collecting expired samples from public hospitals, which were stored under controlled conditions (protected from light and maintained at a consistent temperature between 15 °C and 30 °C), and conducting physical and chemical analyses to assess their stability. The results indicate that naloxone, dexamethasone, and dobutamine may be viable candidates for shelf-life extension programs, as they retained their API content within acceptable limits. However, epinephrine and dopamine exhibited stability challenges, with significant degradation observed in some samples. The findings suggest that pharmaceuticals can remain effective longer than their expiration dates, potentially reducing waste and improving resource management. However, packaging materials and storage conditions are crucial for maintaining drug stability. This study contributes to the ongoing discussion on shelf-life extension and highlights the need for further research to validate these results across different brands and environmental conditions. The implications of this research are significant, as extending shelf lives could enhance drug availability and reduce shortages, particularly for critical emergency medications like naloxone. Future studies should focus on conducting long-term stability tests under various climatic conditions to support shelf-life extension initiatives effectively.

摘要

本研究调查了沙特阿拉伯过期急救药物多巴胺、地塞米松、纳洛酮、肾上腺素和多巴酚丁胺在其标签规定的有效期之后的稳定性。该研究解决了医疗保健领域的一个关键问题,即保质期短会导致大量药物浪费和经济损失。我们使用符合美国药典(USP)和英国药典(BP)指南的经过验证的高效液相色谱(HPLC)方法,分析了这些药物过期后的活性药物成分(API)含量。我们的方法包括从公立医院收集过期样本,这些样本在受控条件下储存(避光并保持在15°C至30°C的恒定温度),并进行物理和化学分析以评估其稳定性。结果表明,纳洛酮、地塞米松和多巴酚丁胺可能是保质期延长计划的可行候选药物,因为它们的API含量保持在可接受的限度内。然而,肾上腺素和多巴胺存在稳定性问题,在一些样本中观察到明显降解。研究结果表明,药品的有效时间可能比其有效期更长,这有可能减少浪费并改善资源管理。然而,包装材料和储存条件对于保持药物稳定性至关重要。本研究为正在进行的关于保质期延长的讨论做出了贡献,并强调需要进一步研究以在不同品牌和环境条件下验证这些结果。这项研究的意义重大,因为延长保质期可以提高药品的可及性并减少短缺,特别是对于像纳洛酮这样的关键急救药物。未来的研究应专注于在各种气候条件下进行长期稳定性测试,以有效支持保质期延长计划。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c65f/12075053/460937a50cba/44446_2025_16_Fig1_HTML.jpg

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