| 首批米非司酮国家对照品的研制 |
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| 引用本文： | 辛中帅,张慧,王嫦鹤,梁成罡.首批米非司酮国家对照品的研制[J].中国药事,2014(10):1148-1152. |
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| 作者姓名： | 辛中帅 张慧 王嫦鹤 梁成罡 |
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| 作者单位： | 1. 中国食品药品检定研究院,北京,100050
2. 陕西省食品药品检验所 |
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| 摘 要： | 目的建立首批米非司酮国家对照品。方法采用红外光谱、紫外光谱、飞行时间质谱和核磁共振谱进行结构确证,反相高效液相色谱法和DSC法测定纯度,通过质量平衡法计算含量。结果确证了米非司酮原料的结构,并确定了首批米非司酮国家对照品的含量为99.5%。结论首批米非司酮国家对照品（批号：410003-201301）可作为米非司酮原料和相关制剂的鉴别和含量测定用对照品。
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| 关 键 词： | 米非司酮 对照品 标准物质 结构确证 含量 |
Standardization of the First National Reference Standard of Mifepristone |
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| Xin Zhongshuai,Zhang Hui,Wang Changhe,Liang Chenggang.Standardization of the First National Reference Standard of Mifepristone[J].Chinese Pharmaceutical Affairs,2014(10):1148-1152. |
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| Authors: | Xin Zhongshuai Zhang Hui Wang Changhe Liang Chenggang |
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| Institution: | Xin Zhongshuai,Zhang Hui,Wang Changhe,Liang Chenggang(National Institutes for Food and Drug Control, Beijing 100050; 1Shaanxi Institute for Food and Drug Control) |
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| Abstract: | Objective To establish the first national reference standard of mifepristone.Methods IR,UV,TOF MS and NMR were used to confirm the structure of mifepristone.The purity of mifepristone was determined by HPLC and DSC.The content of the product was calculated by mass balance method.Results The structure of the material was confirmed and the content of the first national reference standard of mifepristone was assigned as 99.5%.Conclusion The first established mifepristone national reference（batch No：410003-201301）can be efficiently applied for identification and content determination of raw materials and related preparations of mifepristone. |
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| Keywords: | mifepristone reference standard standard substance structure confirmation content |
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