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| 莫达非尼胶囊稳定性的研究 | |
| 引用本文： | 黄利,金描真,吕华冲,邓桂兴,王霆.莫达非尼胶囊稳定性的研究[J].中国医药指南,2012,0(25):3-6. |
| 作者姓名： | 黄利 金描真 吕华冲 邓桂兴 王霆 |
| 作者单位： | 1. 湘北威尔曼制药股份有限公司,湖南 长沙 410331 2. 广东药学院,广东 广州 510006 3. 广州威尔曼新药开发中心,广东 广州 510620 |
| 基金项目： | 湖南科技厅社会发展支撑计划重点项目（编号：2011SK3003） |
| 摘 要： | 目的考察莫达非尼胶囊稳定性。方法根据《中国药典》2005年版要求,对莫达非尼胶囊在市售包装下进行影响因素试验、加速试验和长期试验,考查各条件下药物的外观性状、含量、有关物质和溶出度的变化情况。结果在影响因素试验中,本品在高湿条件下略有吸湿增重,其他条件下各项指标均无明显变化,符合质量标准的规定。结论本品在上市包装条件下稳定,本品有效期可定为2年。 |
| 关 键 词： | 莫达非尼胶囊 影响因素试验 加速试验 长期试验 |
Study on Stability of Modafinil Capsules |
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| HUANG Li,JIN Miao-zhen,LV Hua-chong,DENG Gui-xing,WANG Ting.Study on Stability of Modafinil Capsules[J].Guide of China Medicine,2012,0(25):3-6. | |
| Authors: | HUANG Li JIN Miao-zhen LV Hua-chong DENG Gui-xing WANG Ting |
| Institution: | 1 Xiangbei Welman Pharmaceutical Co.,Ltd,Changsha 410331,China;2 Guangdong Medical College,Guangzhou 510006,China;3 Guangzhou Welman New Medicine Development Centre,Guangzhou 510620,China) |
| Abstract: | Objective To investigate the stability of Modafinil capsules.Methods According to the requirement of Chinese Pharmacopoeia（2005 edition）,the changes of various indexes including appearance,content,related substances and dissolution of Modafinil Capsules were tested in influencing factor test,accelerated test and long-term test.Results In influencing factor test,medicines stood stably in high light test and high temperature test and their weight and content varied slightly in high humidity test.another didn’t change clearly and were in line with the quality standard requirements.Conclution The quality of Modafinil capsules with commercially availabke package is stable and reliable and the shelf-life could be given for two years. |
| Keywords: | Modafinil capsules Influencing factor test Accelerated test Long-term test |
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