| 首批脱苏氨醇~8奥曲肽对照品的研制 |
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| 引用本文： | 任雪,廖海明,杨洪淼,范慧红.首批脱苏氨醇~8奥曲肽对照品的研制[J].中国药事,2012,26(11):1197-1199. |
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| 作者姓名： | 任雪 廖海明 杨洪淼 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： | 目的建立首批脱苏氨醇8奥曲肽对照品。方法应用红外光谱、基质辅助激光解析飞行时间质谱、氨基酸序列分析等对脱苏氨醇8奥曲肽进行结构确证,采用HPLC法测定纯度、检测醋酸含量及氨基酸比值。结果确证了脱苏氨醇8奥曲肽原料的结构,并确定其含量为85.9%。结论首批脱苏氨醇8奥曲肽对照品（批号：140795-201001）的建立便于对奥曲肽杂质进行定性控制。
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| 关 键 词： | 脱苏氨醇8奥曲肽 对照品 高效液相色谱法 |
Standardization of the National Reference Standard of des-Thy-ol8-octreotide |
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| Ren Xue
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Liao Haiming
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Yang Hongmiao
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Fan Huihong.Standardization of the National Reference Standard of des-Thy-ol8-octreotide[J].Chinese Pharmaceutical Affairs,2012,26(11):1197-1199. |
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| Authors: | Ren Xue Liao Haiming Yang Hongmiao Fan Huihong |
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| Institution: | (National Institutes for Food and Drug Control,Beijing 100050) |
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| Abstract: | Objective To establish a national reference standard for des-Thy-ol8-octreotide.Methods IR,MALDI-TOF and Amino Acid Sequence Analysis were used to confirm the structure of des-Thy-ol8-octreotide.HPLC was applied to determine the purity,the content of acetic acid and the ratio of amino acid.Results The structure of the material was confirmed and the content was 85.9%.Conclusion The established national reference standard of des-Thy-ol8-octreotide（Batch No 140795-201001） can efficiently control the quality of des-Thy-ol8-octreotide in octreotide. |
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| Keywords: | des-Thy-ol8-octreotide the national reference standard HPLC |
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