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| 注射用盐酸椒苯酮胺稳定性考察 | |
| 引用本文： | 李茹冰,李若冰,杨向阳,耿智毅,孙智平,万华印.注射用盐酸椒苯酮胺稳定性考察[J].中国药师,2012,15(1):30-32. |
| 作者姓名： | 李茹冰 李若冰 杨向阳 耿智毅 孙智平 万华印 |
| 作者单位： | 1. 广州军区广州总医院药剂科 广州510010 2. 广东省人民医院心外科 3. 广州军区广州总医院心内科 4. 广州市众为生物技术有限公司 |
| 基金项目： | 国家“十二五”新药创制科技重大专项(编号:2011ZX091011-003);科技部创新基金项目(编号:10C26214412687);广东省中国科学院全面战略合作项目(编号:2009B091300065);广州市专利技术产业化示范项目(编号:200903);广州市重大专项(编号:2008A1-E4161) |
| 摘 要： | 目的:考察注射用盐酸椒苯酮胺稳定性.方法:依据《中国药典》要求,进行了注射用盐酸椒苯酮胺稳定性试验,包括:影响因素试验；加速试验；长期试验.结果:考察2年结果显示,三批样品的外观性状、熔点、溶液的颜色和澄清度、pH、干燥失重、含量均无显著变化,单个及总有关物质有所增加.结论:本品以棕色玻璃瓶包装,在常温阴凉处保存,有效期暂定2年. |
| 关 键 词： | 注射用盐酸椒苯酮胺 稳定性 影响因素试验 加速试验 长期试验 |
| 收稿时间： | 2011/9/15 0:00:00 |
| 修稿时间： | 2011/10/10 0:00:00 |
Investigation on Stability of Piperphentonamine Hydrochloride for Injection |
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| Li Rubing,Li Ruobing,Yang Xiangyang,Geng Zhiyi,Sun Zhiping and Wan Huayin.Investigation on Stability of Piperphentonamine Hydrochloride for Injection[J].China Pharmacist,2012,15(1):30-32. | |
| Authors: | Li Rubing Li Ruobing Yang Xiangyang Geng Zhiyi Sun Zhiping and Wan Huayin |
| Institution: | Pharmacy,Guangzhou General Hospital of Guangzhou Military Command Area,Guangzhou 510010,China;Cardial Surgery of the People Hospital of Guangdong Province;Depatment of Cardiology,Guangzhou General Hosptial of Guangzhou Millitary Command Area;Pharmacy,Guangzhou General Hospital of Guangzhou Military Command Area,Guangzhou 510010,China;Pharmacy,Guangzhou General Hospital of Guangzhou Military Command Area,Guangzhou 510010,China;Guangzhou Zhongwei Biotechnology Limited Company |
| Abstract: | Objective： To investigate the stability of piperphentonamine hydrochloride for injection. Method： Influencing factor test, accelerated test and long-term test were performed according to Chinese Pharmacopoeia. Result： Except for a little increase in re- lated substance of the samples, the other indices all showed no significant change. Conclusion ： Piperphentonamine hydrochloride for in- jection is stable. Packaged with amber glass bottle and stored in shady place at room temperature,the tentative expiry date of the injec- tion is two years. |
| Keywords: | Piperphentonamine hydrochloride for injection Stability Influencing factor test Accelerated test Long-term test |
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