在沙特阿拉伯,对某些特定药物产品的质量评估超出了到期日
Haya Aljohar1, Ghadah H Altoum1, Shahad A Alkarni1
1Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
概括
过期的紧急药物,如纳洛和德克萨米他,表现出超过标签日期的稳定性,这表明可能延长保质期. 然而,上腺素和多巴胺降解,强调需要仔细评估和控制的储存条件.
科学领域:
- 制药科学 制药科学
- 药物的稳定性和保质期延长
- 医疗保健资源管理 医疗保健资源管理
背景情况:
- 紧急药物的保质期短,导致医疗保健中的大量浪费和财务损失.
- 评估过期药物的稳定性对于改善药物可用性和减少短缺至关重要.
- 由于严格的到期日期,沙特阿拉伯面临着紧急药物浪费的挑战.
研究的目的:
- 为了研究过期的紧急药物的稳定性 (多巴胺,德克萨米他,纳洛,上腺素,多布他) 超出标签上的过期日期.
- 确定关键紧急药物的保质期延长计划的可行性.
- 评估储存条件对药物稳定性和活性药物成分 (API) 含量的影响.
主要方法:
- 从沙特阿拉伯公共医院收集过期的紧急药物.
- 使用经过验证的高性能液体染色学 (HPLC) 方法,遵守USP和BP的指导方针.
- 分析了API含量,并在受控存储下 (15°C30°C,免受光线影响) 进行物理/化学稳定性评估.
主要成果:
- 纳洛,甲松和多布他胺的API含量保持在可接受的范围内,表明可能延长保质期.
- 上腺素和多巴胺样本显示显著降解,造成稳定性挑战.
- 存储条件和包装材料被确定为影响药物耐用期后稳定性的关键因素.
结论:
- 某些过期的紧急药物可能会在标签上标明的日期之后保持稳定和有效,从而为减少浪费提供了机会.
- 延长保质期的计划需要对药物进行仔细评估,并考虑特定的稳定性概况.
- 需要进一步研究不同气候条件下的长期稳定性,以支持更广泛的保质期延长倡议.
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