| 年帅,黄美容,曹阳,等.氢溴酸沃替西汀杂质的制备研究[J].安徽医药,2020,24(6):1075-1077. |
| 氢溴酸沃替西汀杂质的制备研究 |
| Study on the preparation of vortioxetine hydrobromide impurities |
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| DOI：10.3969/j.issn.1009?6469.2020.06.004 |
| 中文关键词: 氢溴酸沃替西汀 分析样品制备方法 药物污染 化学技术，合成 杂质 |
| 英文关键词: Vortioxetine hydrobromide Analytic sample preparation methods Drug contamination Chemical techniques,syn?thetis Impurity |
| 基金项目:合肥市关键技术研究重大专项(ZR201809200179) |
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| 中文摘要: |
| 目的研究抗抑郁药物氢溴酸沃替西汀杂质， 1，4?二( 2?溴苯基)哌嗪和 2?溴苯基哌嗪的合成；从而为该药原料及片剂的质量研究提供对照品。方法以哌嗪为原料，与邻溴碘苯通过偶联反应得到两种氢溴酸沃替西汀杂质，并经过核磁共振氢谱( 1H NMR)、质谱( MS)等进行了结构确证。结果合成了氢溴酸沃替西汀两种杂质，纯度均在 98.0%以上，为建立质量标准所需的对照品提供了参考。结论合成氢溴酸沃替西汀杂质使用的各种原料经济易得，合成工艺简单，反应条件温和，反应操作简单，所得产品收率和纯度均较高，合成路线可行。 |
| 英文摘要: |
| Objective To study the synthesis of 1，4?bis(2?bromophenyl)piperazine and 2?bromophenylpiperazine，impurities ofthe antidepressant vortioxetine hydrobromide.So as to provide a reference for the quality research of the raw materials and tablets.Methods Using piperazine as raw material，two impurities of vortioxetine hydrobromide were synthesized by coupling reaction with o?bromoiodobenzene，and their structures were confirmed by NMR hydrogen spectroscopy(1H NMR)and Mass spectrometry(MS).Results Two impurities of vortioxetine hydrobromide were synthesized，with a purity of move than 98.0%，which provided a reference for the establishment of quality standards.Conclusion Various raw materials for the synthesis of vortioxetine hydrobro?mide impurities are economical and easy to obtain.The synthetic process is simple，the reaction conditions are mild，and the opera? tion is simple.The yield and purity of the product are high.The synthetic route is feasible. |
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