Rupatadine fumarate compound crystal and tablet

The invention relates to the technical field of biological medicine, in particular to a rupatadine fumarate compound crystal. The melting point range of the rupatadine fumarate compound crystal is 212to 215 DEG C; furthermore, in the X-ray powder diffraction spectrum, characteristic peaks exist at 8...

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Bibliographische Detailangaben
Hauptverfasser: ZHU SHUN, LI HAIFEN, HE XIAPING, WU TINGHUA, CHU YANFENG, DING JUNLU, JIANG JIAWEN
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to the technical field of biological medicine, in particular to a rupatadine fumarate compound crystal. The melting point range of the rupatadine fumarate compound crystal is 212to 215 DEG C; furthermore, in the X-ray powder diffraction spectrum, characteristic peaks exist at 8.2+/-0.1, 9.7+/-0.1, 11.5+/-0.1, 14.1+/-0.1, 16.4+/-0.1, 19.5+/-0.1, 23.4+/-0.1, 25.8+/-0.1, 28.2+/-0.1 and 33.3+/-0.1. In the preparation method of the rupatadine fumarate compound crystal provided by the invention, a solvent adopts a ketone/alcohol/ester compound solvent, the volume ratio of theketone/alcohol/ester is strictly limited in the range of (2-3):(0.5-1):(4-6), so that the total impurity content of the obtained rupatadine fumarate compound crystal is between 0.1 percent and 0.23 percent, and the rupatadine fumarate compound crystal has higher stability and can be stored for a long time. 本发明涉及生物医药技术领域,尤其涉及种富马酸卢帕他定化合物晶体,其熔点范围为212-215℃,并且其X-射线粉末衍射谱图中,在8.2±0.1,9.7±0.1,11.5±0.1,14.1±0.1,16.4±0.1,19.5±0.1,23.