盐酸曲马多与枸橼酸芬太尼在氯化钠注射液中的稳定性研究

目的考察盐酸曲马多与枸橼酸芬太尼注射液在0.9%氯化钠注射液中的配伍稳定性。方法在室温条件下,观察两药配伍后的外观及pH值变化,盐酸曲马多与枸橼酸芬太尼的含量测定采用SinoChrom ODS-BP色谱柱,以乙腈-0.05 mol/L磷酸二氢钾水溶液（25∶75）为流动相,流速为1.0 ml/min。结果配伍液中盐酸曲马多与枸橼酸芬太尼的含量均大于98%,72 h内外观与pH值均未见明显变化。结论在室温条件下,盐酸曲马多与枸橼酸芬太尼注射液在0.9%氯化钠注射液中72 h内保持稳定。

Stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection

Objective To study the stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection.Methods The changes in appearance and pH value of the mixture of the two injections in 0.9% sodium chloride injection within 72 hours at ambient temperature were observed. The concentrations of the two drugs were determined by HPLC. The chromatographic separation was achieved on SinoChrom ODS-BP column, and the mobile phase consisted of acetonitrile:0.05 mol/L potassium dihydrogen phosphate (25:75) at a flow rate of 1.0 ml/min..Results No significant differences were found in the pH value and appearance of the solution. The contents of tramadol hydrochloride and fentanyl citrate were high than 98% within 72 hours.Conclusion The mixture of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection was stability within 72 hours under room temperature.