注射用头孢西丁钠与钠钾镁钙葡萄糖注射液的配伍稳定性考察Δ

目的:考察注射用头孢西丁钠与钠钾镁钙葡萄糖注射液的配伍稳定性。方法:考察室温下8 h内配伍液的外观和pH值变化;采用高效液相色谱法测定配伍液在0、35℃时避光、光照条件下头孢西丁钠的含量、杂质变化。结果:室温下配伍液8 h内外观和pH值均无明显变化。0℃避光、光照条件下,8 h内头孢西丁钠的含量和杂质均符合《中国药典》(2010年版)规定,配伍稳定。35℃避光、光照条件下,8 h时药物含量明显下降,总杂质超出标准规定。结论:注射用头孢西丁钠与钠钾镁钙葡萄糖注射液临床可配伍使用,但应注意控制环境温度,并应在6h内使用完毕。

Compatible Stability of Cefoxitin Sodium for Injection and Sodium Potassium Magnesium Calcium and Glu- cose Injection

OBJECTIVE： To investigate the compatible stability of Cefoxitin sodium for injection with Sodium potassium magnesium calcium and glucose injection. METHODS： The appearance and pH value of the mixed solution were observed within 8 h under room temperature. HPLC method was designed to determine the contents of cefoxitin sodium and impurity at 0 ℃ and 35℃ under light and light-avoided conditions. RESULTS： No significant change was found in the appearance and pH value within 8 h under room temperature. The contents of cefoxitin sodium and impurity complied with Chinese Pharmacopoeia （2010 edition） requirement within 8 h at 0 ℃ under light-avoided or light conditions, with good compatible stability. At 35 ℃ under light-avoided or light conditions, the content of drug decreased significantly at 8 h, and the total impurities exceeded the limit. CONCLUSIONS： Cefoxitin sodium for injection can be mixed with Sodium potassium magnesium calcium and glucose injection for clinical use. Meanwhile, more attention is paid to the environment temperature, and the mixed solution should be used within 6 h.