| 去乙酰毛花苷注射液的杂质研究 |
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| 引用本文： | 李舸远,陈东亚,蔡美明,陈民辉,王 玉. 去乙酰毛花苷注射液的杂质研究[J]. 药学与临床研究, 2011, 19(6): 508-510 |
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| 作者姓名： | 李舸远 陈东亚 蔡美明 陈民辉 王 玉 |
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| 作者单位： | 江苏省食品药品检验所,南京,210008 |
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| 摘 要： | 目的:对去乙酰毛花苷注射液中主要杂质之一杂质A进行分离和结构鉴定.方法:选择高温加热去乙酰毛花苷注射液的方法,制备杂质A,然后经柱层析分离、纯化,最后得到杂质A纯品.分别采用LC-MS、UV、IR、1H-NMR、13C-NMR等方法对该杂质纯品进行结构鉴定.结果:杂质A为地高辛苷元.结论:去乙酰毛花苷注射液在高温、酸、光照的条件下均可产生杂质A,表明应严格控制去乙酰毛花苷注射液生产过程中的高温灭菌条件及遮光贮存.
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| 关 键 词： | 去乙酰毛花苷注射液 地高辛苷元 杂质A 液质联用 紫外 红外 核磁共振 |
| 收稿时间： | 2011-09-23 |
| 修稿时间： | 2011-10-19 |
Impurity Study of Deslanoside Injection |
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| LI Ge-yuan,CHEN Dong-y,CAI Mei-ming,CHEN Ming-hui and WANG Yu. Impurity Study of Deslanoside Injection[J]. Pharmacertical and Clinical Research, 2011, 19(6): 508-510 |
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| Authors: | LI Ge-yuan CHEN Dong-y CAI Mei-ming CHEN Ming-hui WANG Yu |
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| Affiliation: | LI Ge-yuan,CHEN Dong-ya,CAI Mei-ming,CHEN Ming-hui,WANG Yu Jiangsu Institute for Food and Drug Control,Nanjing 210008,China |
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| Abstract: | Objective: To separate the impurity A,a major impurity of deslanoside injection,and identify its structure.Method: After high-temperature processing,impurity A was separated and purified with column chromatography,and then its structure was identified with LC-MS,UV,IR,1H-NMR and 13C-NMR.Result: The impurity A was proved to be digoxigenin.Conclusion: Each of high-temperature processing,acidification and/or highlight can bring about impurity A.It indicates that deslanoside injection must be well controlled in... |
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| Keywords: | Deslanoside injection Digoxigenin Impurities A HPLC-MS UV IR NMR |
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