Method for preparing stable amorphous drug solid preparation

The invention discloses a method for preparing a stable amorphous drug solid preparation. The method comprises the following steps of firstly, preparing an amorphous form by using an anti-solvent crystallization method during amorphous form preparation of nilotinib; secondly, when the amorphous form...

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Hauptverfasser: LAI XIANGXIANG, ZHAN WENHE, LI ZUNHUA, ZHAN ZHIYING, YANG YULAN
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses a method for preparing a stable amorphous drug solid preparation. The method comprises the following steps of firstly, preparing an amorphous form by using an anti-solvent crystallization method during amorphous form preparation of nilotinib; secondly, when the amorphous form is characterized, measuring the amorphous form PXRD so as to obtain a PDF, and measuring amorphousform DSC so as to calculate Rc information; and then, when the optimal process parameters for preparing the stable amorphous form are determined, carrying out PCA on the PDFs of all amorphous form samples, so that the optimal process energy number is obtained. According to the method, a system for evaluating the stability of the amorphous drug by combining the PDF method, the Rc method and the PCAmethod is constructed, the method is a new method which is never seen in previous literatures, and a very useful reference is provided for stability research of the amorphous drug. 本发明公开了一种制备稳定无定型药物固体制剂的方法,首先,在尼洛替尼无定型制备时,使用反溶