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论文编号:ZY025 论文字数:10729,页数:25
摘 要：本论文建立比卡鲁胺的质量标准。通过实验我们确定的含量测定方法如下：Alltima柱子（150×4.6mm，5μ，Alltech），流动相为乙腈-水（47：53），流速是1.0mL/min，检测波长为270nm，进样体积为20μL。此法简便、准确、具专属性和良好的重现性，可用于该药物的质量控制。在有关物质检测项下的破坏性实验中，本品经过酸、碱、氧化、热降解及光照破坏后，产生的杂质峰能与主峰分离，说明该色谱系统能有效分离检测降解产物。在有机溶剂残留量测定项下，利用气相色谱顶空进样法检查乙醇、三氯乙烷、乙醚、二氯甲烷、四氢呋喃、甲苯、氯仿、乙酸乙酯、石油醚、二甲基甲酰胺和二甲基乙酰胺的残留量，DMF为溶剂，进样瓶在80℃下平衡30min，HP-5（0.32mm×30m×0.22μm）毛细管柱，进样口温度200℃，FID检测器温度200℃，柱温50℃。我们依据中国药典各项标准进行分析，最终以药典的形式写出各项目规范。
关键词：比卡鲁胺；质量标准；杂质检查；含量测定
Abstract：In this article we established the quality control standard of Bicalutamide. The methods of content determination which we have adopted were as follows: Alltima column（150×4.6mm，5μ，Alltech）,and the mobile phase consisted of a mixture of acetonitrile and water buffer solution (47:53) pumped at a flow rate of 1.0mL/min. The detection wavelength was 270nm. The methods of content determination was simple，specific and accurate. It can be used for the quality control of Bicalutamide. In destroying experiments of related substance measure item, the samples were destroyed by acid, alkali, oxidation, heating and illumination. The related substance can be separated from Bicalutamide, which showed this chromatographic system being effective. In organic residual solvents measure item, we used headspace GC chromatography to examine ethanol, trichloroethane, aether, dichloromethane, tetrahydrofuran, toluene, chloroform, ethyl acetate, petroleun ether, DMF and DMAC residue in Bicalutamide. DMF was used as solution. Sample had been equilibrated at 80℃ for 30min. HP-5（0.32mm×30m×0.22μm）capillary column was used. The temperature of injector, FID and column were 200℃., 200℃.and 50℃ respectively. We have done other experiments according to Chinese Pharmacopoeia. Finally, we have written quality standard of Bicalutamide in Chinese Pharmacopoeia’s formats.
Keywords：Bicalutamide; Quality standard; Test of impurities；Quality control
目录
中文摘要 I
英文摘要 II
目录 III
1． 绪 论 1
1．1 选题的目的及意义 1
1．2 选题的背景 1
1．3 国内外文献综述 1
1．4 主要研究内容 2
2． 实验部分 3
2．1 实验仪器与试剂 3
2．2 实验步骤 3
3． 结果与讨论 8
3．1 性状结果 8
3．2 鉴别结果 8
3．3 检查结果 10
3．4 含量测定结果 14
4． 总结和展望 17
4．1 总结 17
4．2 展望 19
致 谢 20
参考文献 21
