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目的考察盐酸氢吗啡酮注射液在不同条件下的稳定性,为临床合理用药提供依据。方法模拟临床鞘内给药剂量,将盐酸氢吗啡酮溶于生理盐水中,分别储存于自控镇痛泵(PVC)、玻璃瓶(非PVC)、普通注射器(PVC)中。在25,37℃下,采用HPLC测定盐酸氢吗啡酮第0,1,2,3,5,7,9,11,13,15天的药物浓度,观察外观变化并测定其pH值。结果在不同温度、不同时间点,盐酸氢吗啡酮注射液在自控镇痛泵、玻璃瓶、普通注射器中浓度、外观及pH值均无明显变化,15 d内保持稳定。结论在临床实践中,将盐酸氢吗啡酮注射液分别加入含生理盐水40 m L的自控镇痛泵、玻璃瓶、普通注射器中,使其浓度为0.05 mg·m L~(-1),在输液器内保存10 d以上是可行的。
Objective To investigate the stability of hydromorphone hydrochloride injection under different conditions and provide the basis for clinical rational drug use. Methods The dose of clinical intrathecal injection was simulated. Hydromorphone Hydrochloride was dissolved in normal saline and stored in controlled release analgesia pump (PVC), glass bottle (non-PVC) and ordinary syringe (PVC) respectively. At 25 and 37 ℃, the drug concentrations of hydromorphone hydrochloride on 0, 1, 2, 3, 5, 7, 9, 11, 13 and 15 days were determined by HPLC. Results At different temperatures and different time points, the concentration, appearance and pH of hydromorphone hydrochloride injection in controlled analgesia pump, glass bottle and common syringe did not change significantly, and remained stable within 15 days. Conclusion In clinical practice, the hydromorphone hydrochloride injection was added into the controlled-release analgesia pump, glass bottle and common syringe with normal saline 40 m L respectively to make the concentration 0.05 mg · m L -1 It is possible to store more than 10 days in the infusion set.