利福霉素钠及其制剂水分的研究  

Study on the Water Content of Rifamycin Sodium and Rifamycin Sodium for Injection

作　　者：王立萍[1] 刘英[1] 赵静[2] 

机构地区：[1]河南省食品药品检验所,郑州450003 [2]郑州大学药学院,郑州450003

出　　处：《中国药品标准》2014年第3期187-189,共3页Drug Standards of China

摘　　要：目的:对利福霉素钠及其制剂中的水分进行分析研究。方法:采用费休氏水分测定法、减压干燥法、热重分析法和粉末X射线衍射分析法测定利福霉素钠及其制剂中的水分,并分析其存在状态。结果:利福霉素钠及其无菌分装工艺的注射用利福霉素钠含6个分子水分,以结晶状态存在。结论:利福霉素钠及其制剂中结晶水的存在保证了其稳定性。Objective：To study the water content of rifamycin sodium and its preparation.Methods：To analyze the water content of rifamycin sodium and its preparation by the methods of Karl Fischer titration、loss on drying in vacuo、thermogravimetric analysis and X-ray diffraction.Results：Six molecular crystal water were authenticated in rifamycin sodium and itspreparation .Conclusion：The crystal water makes rifamycin sodium and its preparation more stability.

关 键 词：利福霉素钠 水分 费休氏水分测定法 减压干燥法 热重分析法 粉末X射线衍射分析法 

分 类 号：R921.2[医药卫生—药学]