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拉莫塞特龙3.0μg/mL与德克萨米他松 (0.05,0.1,0.2 mg/mL) 结合在输液溶液中:物理化学稳定性研究

Baoxia Fang¹, Lijun Zhao², Shirong Yu²

¹Department of Pharmacy, Sinopharm Dongfeng General Hospital, Hubei University of Medicine, Shiyan, China.

Dose-response : a publication of International Hormesis Society

|October 17, 2024

概括

拉莫塞特龙化和德克萨米他的组合在保护免受光线影响时,对临床使用是稳定的. 这种抗嘔吐组合在冷藏14天和室温48小时内保持稳定.

科学领域:

药理学药理学是指药理学的学科.
制药化学制药化学制药化学
临床药房临床药房

背景情况:

德克萨米他和血清素3受体对抗剂用于恶心和吐.
化疗引起的和术后的恶心和吐 (CINV/PONV) 是常见的临床挑战.
联合抗治疗需要稳定性评估,以确保安全的临床应用.

研究的目的:

为了研究拉莫塞龙化水化合物的稳定性与甲结合在输液溶液中.
为了确定这种抗嘔吐组合的最佳储存条件.
提高拉莫塞和德克萨米他联合治疗的安全性和临床适用性.

主要方法:

拉莫塞龙化水 (3.0μg/mL) 和甲松 (0.050.2 mg/mL) 在0.9%的化注射中制备.
溶液被包装在聚烯袋或玻璃瓶中.
在冷藏 (14天,黑暗) 和室温 (48小时,黑暗) 下评估稳定性.

主要成果:

药物度在所有解决方案中保持在97%以上,当保护免受光线影响时.
暴露于光线导致药物度随着时间的推移而下降.
没有观察到清晰度,颜色,度或降水的变化; pH 保持稳定.
不溶性颗粒符合中国药典的标准.

结论:

在0.9%的化注射中,拉莫塞龙化和德克萨米他酸的组合是稳定的.
在4°C稳定14天,在25°C稳定48小时,在不受光线影响的情况下.
这些发现支持这种联合抗治疗的安全临床使用.

关键词:

德克萨米他是一种药物相互作用药物相互作用药物的稳定性药物的稳定性高性能液体色谱学高性能液体色谱学拉莫索特朗是什么意思

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