德克塞梅托米丁,胺和利多卡因联合注射溶液的稳定性用于止痛
Isabelle St-Jean1, Djamila Hachemi2, Mihaela Friciu3
1Pharmacy, Université de Montréal, Montreal, Quebec, Canada.
概括
这项研究评估了用于无阿片类药物麻醉的三种药物混合物的稳定性. 在5°C的温度下储存德克斯梅德托米丁,胺和利多卡因的组合,可确保其稳定性长达9天.
科学领域:
- 麻醉学 麻醉学
- 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
背景情况:
- 解决阿片类药物流行需要减少阿片类药物使用,并探索替代疼痛管理策略.
- 联合使用胺,利多卡因和德克斯梅德托米丁正在研究无阿片类药物麻醉和疼痛管理.
- 这三种药物混合在注射器中的物理化学稳定性未经评估.
研究的目的:
- 为了评估一个可注射配方的物理化学稳定性,该配方结合了德克斯米德米丁,胺和利多卡因.
- 确定最佳的储存条件,以保持添加剂的稳定性.
- 提供支持这种无阿片类药物麻醉组合临床使用的数据.
主要方法:
- 准备了一种配方,其中包括德克斯梅德托米丁 (1μg/mL),胺 (1 mg/mL) 和利多卡因 (10 mg/mL).
- 在5°C和21°C的聚烯注射器中存储该配方最多9天.
- 使用经过验证的稳定性指示HPLC方法评估药物度和颗粒数量.
主要成果:
- 胺和利多卡因在5°C和21°C两种温度下保持稳定9天.
- 德克斯梅德托米丁在5°C稳定9天,但在21°C稳定3天.
- 在两种温度下,颗粒数在9天内保持在可注射溶液的可接受限值以下.
结论:
- 德克斯梅德托米丁,胺和利多卡因的添加剂在5°C处在聚烯注射器中储存时可保持长达9天的稳定性.
- 建议冷藏 (5°C),以确保含有德克斯梅托米丁的配方的9天稳定性.
- 这一发现支持这种添加剂在多式无阿片类药物麻醉方案中的潜在使用.
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