注射用头孢呋辛钠室温储存质量稳定性考察

Quality Stability of Cefuroxime Sodium for Injection's Storage at Room Temperature

目的研究注射用头孢呋辛钠在室温(25℃)存放一定时间后的质量变化,为该药的储存管理提供参考。方法选取3个不同厂家的注射用头孢呋辛钠,置25℃下存放,分别于0,1,2,3个月时取样,按2010年版《中国药典(二部)》头孢呋辛钠项下方法,检查其性状、颜色、水分、p H、含量及有关物质是否符合规定。结果 3批不同厂家的注射用头孢呋辛钠质量差异大,主要是颜色不符合要求。结论温度对头孢呋辛钠质量影响大,应警惕近效期药品因储存不当而缩短效期。

Objective To study the quality change of Cefuroxime Sodium for Injection at room temperature（25 ℃） for a certain time,and provide reference for the drug＆#39;s storage management. Methods Cefuroxime Sodium for Injections from 3 manufacturers were selected and stored under room temperature at 25 ℃,The character,color,moisture content,pH,content and related substances of this drug were detected at 0,1,2,3 months respectively according to the provisions of cefuroxime sodium in Chinese Pharmacopoeia（2010 version）. Results The quality of Cefuroxime Sodium for Injection among the 3 manufacturers have significantly differences,the main problem was that the color was not in conformity with the requirements. Conclusion The temperature can significantly influence the stability of Cefuroxime Sodium for Injection,and should pay athention to the shortening of expiration date of the drugs due to poor storage.