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1. 发明申请

WO2010000879A3 PROCESS FOR THE PREPARATION OF NON-GENOTOXIC DIACETYLRHEIN (DIACEREIN) AND FORMULATIONS COMPRISING NON-GENOTOXIC DIACETYLRHEIN 审中-公开
标题翻译：制备非基因型二乙酰基甘氨酸（DIACEREIN）的方法和包含非基因型二乙酰基甘氨酸的制剂
公开(公告)号：WO2010000879A3
公开(公告)日：2010-04-08
申请号：PCT/EP2009064555
申请日：2009-11-03
申请人： EVULTIS SA , MAZZOLA ALESSANDRO , MOIANA SILVIA
发明人： MAZZOLA ALESSANDRO , MOIANA SILVIA
IPC分类号： C07C51/47 , C07C66/02 , C07C69/157
CPC分类号： C07C51/47 , C07C51/412 , C07C67/56 , C07C66/02 , C07C69/017 , C07C69/16
摘要： The present invention is directed to a process for producing non-genotoxic Diacetylrhein (Diacerein), comprising: i) transformation of raw Diacerein (or raw Rhein), into a water-soluble salt; ii) adsorption of the salt Diacerein (or Rhein) solution on a hydrophobic resin; iii) washing with an appropriate solvent to eliminate the impurities (in particular the genotoxic impurities); iv) elution to recover Diacereinor Rhein; v) if the process is applied to Rhein, its transformation to Diacerein by acetylation; vi) acidification of purified Diacerein and its recovery, and drying. The invention is also directed to non-genotoxic Diacerein obtained by the process of the invention, in which the total content of genotoxic impurities is below 1ppm, and suitable for the preparation of pharmaceutical formulations, in particular capsules, for human and veterinary use, in agreement with the current Health Authorities request.
摘要翻译：本发明涉及生产无基因毒性的二乙酰纤维素（双醋瑞因）的方法，包括：i）将原始双醋瑞因（或生大黄酸）转化为水溶性盐; ii）盐双醋瑞因（或大黄酸）溶液在疏水性树脂上的吸附; iii）用合适的溶剂洗涤以消除杂质（特别是遗传毒性杂质）; iv）洗脱以回收Diacereinor Rhein; v）如果该过程应用于Rhein，则其通过乙酰化转化为双醋瑞因; vi）纯化的双醋瑞因的酸化及其回收和干燥。本发明还涉及通过本发明方法获得的非基因毒性的双醋柳黄素，其中基因毒性杂质的总含量低于1ppm，并且适用于制备用于人和兽医用途的药物制剂，特别是胶囊与当前的卫生当局请求达成一致。

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