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汪建明, 陈砚美, 张海禄, 张炎锋, 陈敏华. 达沙替尼原料药的晶型分析[J]. 中国药科大学学报, 2015, 46(5): 575-578. DOI: 10.11665/j.issn.1000-5048.20150510
引用本文: 汪建明, 陈砚美, 张海禄, 张炎锋, 陈敏华. 达沙替尼原料药的晶型分析[J]. 中国药科大学学报, 2015, 46(5): 575-578. DOI: 10.11665/j.issn.1000-5048.20150510
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WANG Jianming, CHEN Yanmei, ZHANG Hailu, ZHANG Yanfeng, CHEN Minhua. Crystal form identification of dasatinib in tablets[J]. Journal of China Pharmaceutical University, 2015, 46(5): 575-578. DOI: 10.11665/j.issn.1000-5048.20150510
Citation: WANG Jianming, CHEN Yanmei, ZHANG Hailu, ZHANG Yanfeng, CHEN Minhua. Crystal form identification of dasatinib in tablets[J]. Journal of China Pharmaceutical University, 2015, 46(5): 575-578. DOI: 10.11665/j.issn.1000-5048.20150510
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达沙替尼原料药的晶型分析

Crystal form identification of dasatinib in tablets

    摘要
  • 摘要: 建立片剂中达沙替尼原料药的晶型分析方法。使用X射线粉末衍射(XRPD)和固态核磁共振光谱(ssNMR)，分别对达沙替尼市售片剂施达赛®；和依尼舒®；中达沙替尼原料药的晶型进行分析。结果显示，施达赛®；片剂中达沙替尼原料药为一水合物，而依尼舒®；片剂中达沙替尼原料药为无水晶型。在施达赛®；片剂中没有观察到无水晶型，而依尼舒®；片剂中没有观察到一水合物。XRPD与ssNMR两种方法检测结果一致，均可用于固体片剂中达沙替尼原料药的晶型分析。

     

    Abstract: The aim of this study was to establish the methods to identify crystal form of dasatinib in tablets. X-ray powder diffraction(XRPD)and solid-state nuclear magnetic resonance(ssNMR)were used to analyze the crystal form of dasatinib in Sprycel® tablets and Yinishu® tablets. The results showed that monohydrate and anhydrate were identified in Sprycel® and Yinishu® tablets respectively, with no detectable anhydrate in Sprycel® tablets and no detectable monohydrate in Yinishu® tablets. The results of XRPD and ssNMR were consistent, and could be both applied in the crystal form identification of dasatinib in tablets.

     

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