头孢他啶与钠钾镁钙葡萄糖注射液的配伍稳定性

Compatible Stability of Ceftazidime and Sodium Potassium Magnesium Calcium and Glucose Injection

目的:研究注射用头孢他啶与钠钾镁钙葡萄糖注射液的配伍稳定性。方法:观察室温下8h内配伍液的外观、pH和不溶性微粒。采用高效液相色谱法测定配伍液在0℃、35℃、避光、光照条件下头孢他啶的含量、杂质变化。结果:配伍液8h内外观、pH和不溶性微粒数没有变化。0℃光照、避光条件下,8 h后配伍液中药物含量和杂质都符合《中国药典》规定。35℃光照条件下4 h时药物含量符合要求。但最大单杂超出范围。结论:注射用头孢他啶与钠钾镁钙葡萄糖注射液的配伍稳定性受温度影响较大,夏季高温应注意环境降温,并于2h内输注完毕。

To investigate the compatible stability of ceftazidime for injection with sodium potassium magnesium calcium and glucose injection. Methods： The appearance, pH and particle matter of the mixed solution were observed within 8 hours at room temperature. An HPLC method was designed to study the changes of contents of ceftazidime and impurities under 0℃, 35℃, light or light-proof conditions. Results： No differences were found in the appearance, pH value and particle matter within 8 hours. All the contents of ceftazidime and impurities conformed to the standard of Chinese Pharmacopeia under 0 ℃and light or light-avoided conditions within 8 hours. But under the 35℃ and light condition the content of maximum single impurity was out of range within 4 hours, although the content of ceftazidime conformed to the requirement. Conclusion： Temperature has a significant influence on the compatible stability of Cef-tazidime for injection with sodium potassium magnesium calcium and glucose injection. In hot summer days, temperature reduction should be paid attention to and the mixed solution should be used within 2 hours.