室温下注射用头孢西丁稳定性研究

Study on Stability of Cefoxitin Sodium for Injection at Room Temperatures

目的探讨注射用头孢西丁在室温贮存条件下的稳定性,为温度变异条件下的药品贮存提供依据。方法参照2015年版《中国药典(二部)》注射用头孢西丁项下方法测定不同温度条件下药品含量、有关物质含量、酸度,检查药品澄清度及颜色;采用药物稳定性长期试验方法研究注射用头孢西丁在室温下贮存6个月后的稳定性及杀菌能力变化;采用经典恒温法研究注射用头孢西丁热降解规律,预测其在不同温度条件下的有效期。结果注射用头孢西丁在26℃和30℃分别贮存6个月和3个月后,其含量、有关物质、酸度及溶液澄清度与颜色仍符合法定质量标准要求,杀菌能力未发生明显变化;在试验温度范围内的热降解符合一级动力学特征,在20℃和25℃温度条件下,预期有效期分别为29个月和17个月。结论温度对注射用头孢西丁的稳定性有较大影响,贮存温度在20～30℃波动时,注射用头孢西丁至少在3个月内可维持质量稳定。

Objective To investigate the stability of Cefoxitin Sodium for Injection at room temperature,and to provide a evidence for its storage in the condition of temperature fluctuation. Methods According to the detection method of Cefoxitin Sodium for Injection in Chinese Pharmacopoeia（2015 Edition,Volume Ⅱ ）,the drug content,related substances content,acidity were determined, the clarity and color were checked at different temperatures. The stability and bactericidal activity of Cefoxitin Sodium for Injection after storage at room temperature for 6 months were studied by long- term stability test. The thermal degradation of Cefoxitin Sodium for Injection was studied by classic homeothermia method,and the validity periods at different temperatures were predicted. Results The content,related substances,acidity,solution clarity and color of Cefoxitin Sodium for Injection still met the requirements of the statutory quality standards after 6 months and 3 months of storage at 26 ℃ and 30 ℃ ,respectively,and the bactericidal ability did not change significantly. The thermal degradation in the range of test temperature conformed to the first- order kinetic characteristics, and the expected validity periods were 29 months and 17 months at 20 ℃ and 25 ℃ ,respectively. Conclusion The temperature has significant influence on the stability of Cefoxitin Sodium for Injection. The quality of Cefoxitin Sodium for Injection can be maintained for at least 3 months at the storage temperature in the range of 20 to 30 ℃.