Di Stefano V, Pitonzo R, Bavetta S, Polidori P, Sidoti Mg
Department of Chemistry and Pharmaceutical Technology, Faculty of Pharmacy, University of Palermo, Via Archirafi 32, 90123 Palermo, Italy.
Int J Pharm Investig. 2011 Jan;1(1):48-52. doi: 10.4103/2230-973X.76729.
Tramadol hydrochloride (HCl) and ketorolac tromethamine are analgesic drugs, which are commonly used in combination in postoperative pain management. According to some studies, metoclopramide and magnesium sulfate (MgSO(4)) as adjuvant agents can improve analgesia and decrease the need for other pain drugs.
The chemical stability of tramadol HCl combined with ketorolac tromethamine and metoclopramide HCl has been studied using a stability-indicating high-performance liquid chromatographic assay method. Calibration curves were produced using linear regression of the peak area against concentration of each drug, with an r(2) value ≥ 0.96. Our aim was to investigate the stability of admixture solution of tramadol HCl combined with ketorolac tromethamine and metoclopramide HCl for 48 h (25°C) and 5 days (5°C), with MgSO(4), which has never been assessed.
Data obtained for admixtures prepared and stored at temperatures of 25°C and 5°C, show that all drugs have reached at least 98% of the initial concentration.
For the purpose of pre-preparing drug admixtures to use with confidence, tramadol HCl infusions may be prepared in advance and then thawed before use in clinical units. On the basis of our results, the intravenous mixture of tramadol (7.69 mg/mL), metoclopramide (0.19 mg/mL), ketorolac (1.15 mg/mL), and magnesium sulfate (77 mg/mL) may be considered for a possible commercial formulation.
盐酸曲马多和酮咯酸氨丁三醇是镇痛药，常用于术后疼痛管理。根据一些研究，甲氧氯普胺和硫酸镁作为辅助药物可改善镇痛效果并减少对其他止痛药物的需求。
采用稳定性指示高效液相色谱分析法研究了盐酸曲马多与酮咯酸氨丁三醇和盐酸甲氧氯普胺的化学稳定性。通过将每种药物的峰面积与浓度进行线性回归生成校准曲线，相关系数（r²）值≥0.96。我们的目的是研究盐酸曲马多与酮咯酸氨丁三醇和盐酸甲氧氯普胺的混合溶液在加入硫酸镁的情况下于25°C保存48小时和5°C保存5天的稳定性，此前从未对此进行过评估。
在25°C和5°C温度下制备和储存的混合液所获得的数据表明，所有药物的浓度均至少达到初始浓度的98%。
为了能够放心地预先制备药物混合液，盐酸曲马多输注液可提前配制，然后在临床使用前解冻。根据我们的研究结果，盐酸曲马多（7.69毫克/毫升）、甲氧氯普胺（0.19毫克/毫升）、酮咯酸（1.15毫克/毫升）和硫酸镁（77毫克/毫升）的静脉混合液可考虑制成一种可能的商业制剂。
