| 注射用福美坦的稳定性考察 |
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| 引用本文： | 彭丽琳,唐小海,安林,宋鑫,胡晓,杨红.注射用福美坦的稳定性考察[J].中国药房,2011(1):58-60. |
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| 作者姓名： | 彭丽琳 唐小海 安林 宋鑫 胡晓 杨红 |
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| 作者单位： | 四川大学华西药学院;重庆莱美药业股份有限公司;四川大学制药与生物工程系; |
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| 基金项目： | 重庆莱美药业股份有限公司对该课题的资助 |
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| 摘 要： | 目的:考察注射用福美坦的稳定性。方法:根据《中国药典》2005年版要求,对注射用福美坦在市售包装条件下进行影响因素试验、加速试验和长期试验,考察各条件下药物含量、外观、pH值及有关物质等指标变化情况。结果:温度、湿度、光线及贮存时间等对注射用福美坦的质量指标影响不大,各项质量指标的检测结果均符合《中国药典》要求。结论:注射用福美坦在市售包装条件下的有效期内质量稳定、可靠。
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| 关 键 词： | 注射用福美坦 稳定性 影响因素试验 加速试验 长期试验 考察 |
Study on Stability of Formestane for Injection |
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| PENG Li-lin,YANG Hong TANG Xiao-hai,AN Lin,SONG Xin.Study on Stability of Formestane for Injection[J].China Pharmacy,2011(1):58-60. |
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| Authors: | PENG Li-lin YANG Hong TANG Xiao-hai AN Lin SONG Xin |
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| Institution: | PENG Li-lin,YANG Hong(West China School of Pharmacy,Sichuan University,Chengdu 610041,China) TANG Xiao-hai,AN Lin,SONG Xin(Chongqing Lummy Pharmaceutical Co.,Ltd.,Chongqing 401336,HU Xiao(Dept.of Pharmaceutical and Biological Engineering,China) |
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| Abstract: | OBJECTIVE:To study the stability of Formestane for injection.METHODS:According to the requirement of Chinese Pharmacopeia(2005 edition),the quality of Formestane for injection was investigated in influencing factor test,accelerated test and long-term test,and the change of content,appearance,pH value and other index of samples were observed.RESULTS: Several factors influenced the quality of Formestane for injection slightly,such as temperature,humidity,light and time of storage. The indexes of quality were ... |
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| Keywords: | Formestane for injection Stability Influencing factor test Accelerated test Long-term test Investigation |
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