双苯氟嗪稳定性的影响因素研究  

Study on influence factors of dipfluzine

作　　者：陈汝红[1] 郭毅[1] 王熳[1] 王永利[2] 

机构地区：[1]河北省药品检验所,河北石家庄050011 [2]河北医科大学药学院,河北石家庄050017

出　　处：《中国医药导报》2011年第10期37-38,共2页China Medical Herald

基　　金：国家高科技研究发展计划(863计划)资助项目(国家级一类新药双苯氟嗪的开发;编号:2002AA2Z3132)

摘　　要：目的:探讨双苯氟嗪的固有稳定性,了解影响其稳定性的环境因素。方法:双苯氟嗪在高温、高湿、强光条件下放置0、5、10 d,采用HPLC、滴定等方法考察性状、熔点、含量、有关物质、风化性或吸湿性随时间的变化情况。结果:双苯氟嗪各项质量考察指标变化不大。结论:试验结果表明双苯氟嗪性质比较稳定,但对光﹑热稍显敏感,包装、贮藏应注意遮光、密闭。Objective：To research natural stability of dipfluzine,acquire environment factors having influence on stability of dipfluzine.Methods：Dipfluzine was placed for 0,5,10 days in conditions of high temperature,high humidity,strong light irradiation.Observing and studying the variations of character,melting point,content,related substance,weathering or hygroscopicity with time by HPLC and titration methods etc.Results：All quality indicators of dipfluzine less varied.Conclusion：The test showed dipfluzine was stable but sensitivity to light and heat.Its package and storage should pay attention to shading light and closeness.

关 键 词：双苯氟嗪 稳定性 影响因素 

分 类 号：R954[医药卫生—药学]