CAJ | 학술논문

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溎和依尼舒溎中达沙替尼原料药的晶型进行分析。结果显示，施达赛溎片剂中达沙替尼原料药为一水合物，而依尼舒溎片剂中达沙替尼原料药为无水晶型。在施达赛溎片剂中没有观察到无水晶型，而依尼舒溎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。
건립편제중체사체니원료약적정형분석방법。사용X사선분말연사（XRPD）화고태핵자공진광보（ssNMR），분별대체사체니시수편제시체새연화의니서연중체사체니원료약적정형진행분석。결과현시，시체새연편제중체사체니원료약위일수합물，이의니서연편제중체사체니원료약위무수정형。재시체새연편제중몰유관찰도무수정형，이의니서연편제중몰유관찰도일수합물。 XRPD여ssNMR량충방법검측결과일치，균가용우고체편제중체사체니원료약적정형분석。
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.