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《China Pharmaceuticals》 2018-18
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Study on Stability of Cefoxitin Sodium for Injection at Room Temperatures

Wang Hongrui;Xu Yuhong;He Ying;Fuyong People’s Hospital of Shenzhen;The Eighth Affiliated Hospital of Sun Yat-Sen University;  
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 ℃.
【Fund】: 广东省深圳市科技计划项目[201202160]
【CateGory Index】: R927.11
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