Stability and compatibility of the mixture of tramadol, ketorolac, metoclopramide and ranitidine in a solution for intravenous perfusion

J. Cabrera , M. Mancuso , F. Cabrera-Fránquiz , J. Limiñana , A. Díez
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引用次数: 10

Abstract

Objective

To determine whether a mixture for intravenous perfusion containing tramadol (5 mg/ml), ranitidine (1.5 mg/ml), ketorolac (1.5 mg/ml) and metoclopramide (0.5 mg/ml) in a 0.9% sodium chlorides solution is compatible and stable at room temperature during a 48-hour period.

Methods

We tested the mixture for stability using the HPLC technique (high performance liquid chromatography), with parallel visual assessments of any changes in colour, appearance of precipitate or phase separation indicating incompatibilities between the components.

Results

At the end of the trial, chromatography data showed a mean metoclopramide concentration between 100% and 105% of the initial level, while concentrations of tramadol, ketorolac and ranitidine were between 99% and 102% of initial levels. There was no evidence of incompatibility between the drugs at any time during the study period.

Conclusions

The combination is stable as a solution and its components are physically and chemically compatible in the concentrations used in the study, during at least 48 hours at room temperature.

曲马多、酮咯酸、甲氧氯普胺和雷尼替丁在静脉灌注溶液中的稳定性和相容性
目的观察曲马多(5mg /ml)、雷尼替丁(1.5 mg/ml)、酮咯酸(1.5 mg/ml)、甲氧氯普胺(0.5 mg/ml)在0.9%氯化钠溶液中静脉灌注后48小时的相容性和稳定性。方法:采用高效液相色谱法(HPLC)检测混合物的稳定性,并对颜色、沉淀物外观或相分离的变化进行并行视觉评估,以表明组分之间的不相容性。结果实验结束时,色谱数据显示甲氧氯普胺的平均浓度在初始水平的100% ~ 105%之间,曲马多、酮咯酸和雷尼替丁的浓度在初始水平的99% ~ 102%之间。在研究期间,没有证据表明两种药物之间存在不相容性。结论:该制剂在室温下至少48小时内是稳定的溶液,其组成成分在研究中使用的浓度下具有物理和化学相容性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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