Refining method of clopidogrel bisulphate

The invention belongs to the technical field of pharmaceutical chemical manufacturing, and particularly relates to a refining method of clopidogrel bisulphate. The method comprises the steps of material dissolution, organic extraction, organic phase removal, dissolution and decoloration treatment, c...

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Hauptverfasser: CHEN RANYING, ZHANG HUITING, NIAN BEILEI, YIN HENGLIANG, QIAN DAN, XU WENBIN, WANG WENHUA, LIU JIFANG, LAI SHEN, XUE JUAN, FAN ZHEN, YANG MING, WU YANJIE, WANG JUNCHEN, REN HEYI
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention belongs to the technical field of pharmaceutical chemical manufacturing, and particularly relates to a refining method of clopidogrel bisulphate. The method comprises the steps of material dissolution, organic extraction, organic phase removal, dissolution and decoloration treatment, crystallization, finished product preparation and the like. The main technical thought of the invention is as follows: clopidogrel bisulphate to be refined is dissolved in purified water, clopidogrel free alkali is prepared under the action of sodium carbonate, and then the free alkali reacts with sulfuric acid in a mixed solvent (acetone, methanol and purified water) and is further crystallized to prepare the high-purity II type clopidogrel bisulphate. The refining process well solves the quality problems of unstable crystal form, high impurity content and red color in the clopidogrel hydrogen sulfate prepared by the existing industrial production. According to the process, the quality standard of related products