The invention discloses an improved process for the purification of ropinirole hydrochloride by dissolving or suspending crude ropinirole base or its pharmaceutically acceptable salt in a suitable solvent, reacting with a nitrogenous base to form an imine derivative, optionally treating the reaction mixture with a base to adjust the pH, and isolating purified ropinirole hydrochloride. The invention also provides for a pharmaceutical composition comprising pure ropinirole hydrochloride as active ingredient.
该发明揭示了一种改进的过程,用于通过将粗制
罗匹尼罗碱或其药学上可接受的盐溶解或悬浮在合适的溶剂中,与含氮碱反应形成
亚胺衍
生物,可选择地用碱处理反应混合物以调整pH,并分离纯化的
罗匹尼罗盐酸盐。该发明还提供了一种包含纯
罗匹尼罗盐酸盐作为活性成分的药物组合物。