注射用头孢替坦二钠的稳定性研究

Study on the stability of cefotetan disodium for injection

目的考察光照、温度、湿度、残氧率和p H值对头孢替坦二钠稳定性的影响,并考察头孢替坦二钠与4种输液配伍的稳定性。方法采用《美国药典》的检测方法测定头孢替坦二钠在上述因素影响下的质量分数,采用2010年版《中国药典》二部附录ⅨA第一法测定头孢替坦二钠的颜色,采用2010版《中国药典》二部附录ⅧM第一法A测定头孢替坦二钠的水分。结果注射用头孢替坦二钠对光照、高温、高湿、O2及p H均敏感,在4种常用临床溶液中均可安全使用。结论头孢替坦二钠在包装、贮存和临床使用时应严格控制条件,以保证药品使用安全有效。

Objective To investigate the influences of light,temperature,humidity,oxygen remain and pH on the stability of cefotetan disodium,and the stability of the compatibility of complexes of cefotetan disodium with four other infusions. Methods The analysis method in USP was employed to determine the mass concentration of cefotetan disodium. The first method of appendix ⅨA of Ch P（ edition 2010） was used to detect the colour of cefotetan disodium,and the first method A of appendix Ⅷ M of Ch P（ edition 2010）was used to detect the water content of cefotetan disodium. Results Cefotetan disodium was sensitive to light,high temperature,high humidity,oxygen remain and pH,and can be used safely with four other regular infusions in clinic. Conclusion The conditions of packing,storage and clinical use of cefotetan disodium should be strictly controlled to ensure the safety and effectiveness of this drug.