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

关键词:  盐酸氢吗啡酮  自控镇痛泵  稳定性  PVC输液袋  非PVC输液袋

Key words:  hydromorphone hydrochloride  patient controlled analgesia  stability  PVC infusion bags  non-PVC infusion bags

摘要:

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 mL的自控镇痛泵、玻璃瓶、普通注射器中，使其浓度为0.05 mg·mL^-1，在输液器内保存10 d以上是可行的。

Abstract:

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 pH was measured. RESULTS No notable changes in pH or appearance were observed at different temperatures, different time and implantable infusion system for 15 d. CONCLUSION It is appropriate that 0.05 mg·mL^-1 hydromorphone hydrochloride is in 40 mL 0.9% sodium chloride injection in different implantable infusion system to keep stable for at least 10 d from the perspective of drug stability.