盐酸曲马多与硫酸镁注射液在氯化钠注射液中的配伍稳定性研究

Stability of tramadol hydrochloride combined with Magnesium Sulfate Injection in 0.9% sodium chloride injection

目的考察盐酸曲马多注射液与硫酸镁注射液配伍的稳定性,为临床用药安全提供依据。方法模拟临床用药方案,观察盐酸曲马多与硫酸镁注射液在0.9%氯化钠注射液配伍后,在168 h内的外观、p H值及不溶性微粒变化,并采用高效液相色谱法测定盐酸曲马多质量浓度的变化。结果配伍液在室温条件下外观、p H值及不溶性微粒均无明显变化,两药配伍后盐酸曲马多相对质量浓度>99%。结论盐酸曲马多注射液与硫酸镁注射液在0.9%氯化钠注射液配伍后,在室温条件下168 h可保持稳定。

Objective To investigate the stability of Tramadol Hydrochloride Injection combined with Magnesium Sulfate Injection in 0.9% sodium chloride injection, to provide an experimental basis for clinical drug safety. Methods According to the common concentration and preparation methods used in clinic, the appearance, pH values, and insoluble particles in combined solution were observed within 168 h, and the concentrations were determined by HPLC method after combination of tramadol with magnesium sulfate. Results No obvious change was found in the appearance, pH values and insoluble particles of the mixtures at room temperature. The contents of tramadol hydrochloride were above 99%. Conclusion Tramadol Hydrochloride Injection combined with Magnesium Sulfate Injection are stable in 0.9% sodium chloride injection under room temperature within 168 h.