盐酸氢吗啡酮在不同条件下的稳定性研究

Stability Study of Hydromorphone Hydrochloride Under Different Conditions

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 solution in different conditions in order to provide the references information for rational drug in clinical practice. METHODS In a simulated clinical situation, hydromorphone hydrochloride was undergone appropriate dilution with 0.9% sodium chloride injection and was stockpiled in infusion bags（PVC）, infusion bags（non-PVC） or drug infusion pumps（PVC）. Then HPLC was employed to determine hydromorphone concentrations at 0, 1, 2, 3, 5, 7, 9, 11, 13, 15, 17 d under 25 ℃ or 37 ℃. The appearance was observed and the p H was measured. RESULTS No notable changes in p H or appearance were observed at different temperatures, different time and implantable infusion system for 15 d. CONCLUSION It is appropriate that 0.05 mg·m L^（-1） hydromorphone hydrochloride is in 40 m L 0.9% sodium chloride injection in different implantable infusion system to keep stable for at least 10 d from the perspective of drug stability.