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在临床储存条件下对复制的阿扎西提丁进行定量稳定性评估
Stefano Ruga1, Renato Lombardi2, Tonia Bocci3
1Department of Health Sciences, University of Catanzaro Magna Græcia, 88100 Catanzaro, Italy.
Pharmaceuticals (Basel, Switzerland)
|January 28, 2026
概括
阿扎西提丁 (AZA) 在室温下不稳定,在24小时内降解超过85%. 在4°C的冷却将降解速度减慢到26%的损失,但立即使用仍然对疗效和成本效益至关重要.
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:
- 阿扎西提丁 (AZA) 是一种关键的化疗剂.
- 了解AZA在临床条件下的稳定性对于有效的治疗和废物减少至关重要.
- 目前的存储和处理协议需要验证以实现最佳的AZA利用.
研究的目的:
- 在标准的临床储存条件下评估阿扎西蒂丁 (AZA) 溶液的稳定性.
- 为了比较AZA在室温 (23±2°C) 和冷藏 (4°C) 的稳定性.
- 为实用的储存协议提供信息,以尽量减少药物降解,浪费,并提高成本效益.
主要方法:
- 准备和储存在23±2°C和4°C的阿扎西提丁溶液 (1mg/mL).
- 使用经过验证的高性能液态染色学 (HPLC) 方法与紫外线检测来评估稳定性.
- 在HPLC方法中使用了C18柱和酸缓冲体和酸的移动相,对AZA及其初级降解产品具有特异性.
主要成果:
- 阿扎西提丁在室温下呈现快速降解,在24小时内损失超过85%.
- 在4°C的冷却显著提高了稳定性,在24小时内仅显示大约26%的损失.
- 一个主要降解产物,可能是开环水解物种,被HPLC-UV.识别和监测.
结论:
- 复制的阿扎西提丁 (AZA) 是高度不稳定的,需要严格遵守即时使用协议.
- 在4°C的冷藏只能提供有限的稳定性延伸,需要在短时间内给药.
- 遵守处理指南对于确保治疗疗效和最大限度地减少与AZA降解相关的经济浪费至关重要.
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