摘要
目的:对美国药典30版注射用头孢孟多酯和英国药典2005年版收载的头孢孟多酯钠中碳酸钠的含量测定方法的可行性进行考证。方法:采用酸碱滴定法和离子色谱法。结果:注射用头孢孟多酯钠的离子色谱检测中检出碳酸根离子和甲酸根离子,并且随着检测溶液形成时间的增加水解产生的甲酸也增加。结论:注射用头孢孟多酯钠中的碳酸钠被头孢孟多酯钠水解产生的甲酸中和,不能用酸碱滴定法对头孢孟多酯钠中的碳酸钠定量。因此,美国药典和英国药典在注射用头孢孟多酯和头孢孟多酯钠标准中收载的方法并不可行。
Objective： Research on the assay method of sodium carbonate in Cefamandole Nafate for Injection in USP and Cefamandole Nafate in Ph Eur. Methods： An acerbity titration method and ion chromatogram method was used. Results： Carbonate acid and formyl was Checked out in Cefamandole Nafate for Injection by IC. The formyl increased along with the process of preparation Cefamandole Nafate solution. Condusions： Sodium carbonate was neutralized by formyl acid due to the hydrolyzation of Cefamandole Nafate. Quantitative analysis sodium carbonate in Cefamandole Nafate by acerbity titration method is not feasible.
出处
《中国药品标准》
CAS
2008年第4期254-256,共3页
Drug Standards of China
关键词
注射用头孢孟多酯钠
碳酸钠
甲酸
Cefamandole Nafate for Injection
Sodium carbonate
Formyl acid
