| 肝素钠鉴别及有关物质检查用国家对照品的研制 |
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| 引用本文： | 宋玉娟,任丽萍,王悦,廖海明,郝苏丽,范慧红.肝素钠鉴别及有关物质检查用国家对照品的研制[J].中国药事,2011,0(9):885-886,898. |
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| 作者姓名： | 宋玉娟 任丽萍 王悦 廖海明 郝苏丽 范慧红 |
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| 作者单位： | (中国食品药品检定研究院,北京100050) |
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| 摘 要： | 目的建立肝素钠鉴别及有关物质检查用国家对照品。方法采用红外光谱、核磁法进行结构确认,SEC-MALLS法测绝对分子质量,毛细管电泳和离子色谱法进行纯度分析。结果本批待标品红外吸收峰与肝素钠的结构特征相吻合,核磁谱图解析结果与文献一致,毛细管电泳和离子色谱法纯度均为100%。结论所建肝素钠鉴别及有关物质检查用对照品可用作国家对照品。
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| 关 键 词： | 肝素钠 国家对照品 质量分析 |
Study on Establishment for National Reference Standard of Heparin Sodium's Identification and Related Substances |
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| Song Yujuan,Ren Liping,Wang Yue,Liao Haiming,Hao Suli,Fan Huihong.Study on Establishment for National Reference Standard of Heparin Sodium's Identification and Related Substances[J].Chinese Pharmaceutical Affairs,2011,0(9):885-886,898. |
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| Authors: | Song Yujuan Ren Liping Wang Yue Liao Haiming Hao Suli Fan Huihong |
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| Institution: | Song Yujuan,Ren Liping,Wang Yue,Liao Haiming,Hao Suli and Fan Huihong(National Institutes for Food and Drug Control,Beijng 100050) |
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| Abstract: | Objective To establish a national reference standard for heparin sodium's identification and related substances.Methods Structure elucidation by IR and NMR,determination of absolute molecular weight by SEC-MALLS method,purity test by capillary electrophoresis and ion chromatography.Results The IR spectrum met the structural features of heparin and NMR spectrum is in accordance with literature;the purity of capillary electrophoresis and ion chromatography were both 100%.Conclusion The establishment of nation... |
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| Keywords: | heparin sodium national reference standard quaity analysis |
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