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盐酸安非他酮缓释片稳定性的研究

Study on the stability of amfebutamone hydrochloride controlled-release tablet

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【作者】 李晓昕戴建国陈庆才

【Author】 LI Xiao xin,DAI Jian guo,CHEN Qing cai (? Nanjing Aosaikang Medicinal Science Co.Ltd.,Nanjing 210029, China )

【机构】 南京奥赛康医药科技有限公司南京奥赛康医药科技有限公司 南京210029南京210029南京210029

【摘要】 目的 :研究盐酸安非他酮缓释片的稳定性。方法 :经空气、光照、高温、高湿、加速、室温条件放置 ,测定其稳定性。结果 :本品经各种试验条件的影响 ,其外观均为白色薄膜衣片 ,除去薄膜衣显类白色 ,释放度、含量、有关物质等各项考察指标与放置前比较均无明显变化。结论 :本品具有较好的稳定性。

【Abstract】 Objective:To study the stability of amfebutamone hydrochloride controlled release tablet.Methods:Under exposed to air,light,high temperature,heavy humidity,accelerated speed test and room temperature,the appearance and the content of amfebutamone hydrochloride were examined.Results:Through varied testing condition,the appearance of this tablet appeared to be white coated tablet.After the tablet was decoated,it is off white.All the specifications examined including releasing,assay and related substances were not changed in comparison with those in pre exposure.Conclusion:Amfebutamone hydrochloride controlled release tablet had good stability.\;

  • 【文献出处】 中国新药杂志 ,Chinese New Drugs Journal , 编辑部邮箱 ,2002年08期
  • 【分类号】R944
  • 【被引频次】2
  • 【下载频次】123
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