申请人:PRODOTTI CHIMICI E ALIMENTARI SPA
公开号:EP2221313A1
公开(公告)日:2010-08-25
Process for preparing the disodium salt of ursodeoxycholic acid 3,7-disulfate comprising the following steps: a) reaction of ursodeoxycholic acid with a complex of trimethylamine-sulphuric anhydride, to obtain the ursodeoxycholic acid 3,7-disulfate di-trimethylammonium reaction intermediate; b) treatment of the di-trimethylammonium salt of ursodeoxycholic acid 3,7-disulfate with organic or inorganic sodium bases to obtain the tri-sodium salt of ursodeoxycholic acid 3,7-disulfate; c) treatment with an inorganic acid in presence of isopropanol up to a pH comprised in the range between 3.0 and 4.5, to obtain the disodium salt of ursodeoxycholic acid 3,7-disulfate in solution; d) removal of the salts present and obtaining the disodium salt ofursodeoxycholic acid 3,7-disulfate.
制备3,7-二硫酸盐熊去氧胆酸二钠的过程包括以下步骤:a)将熊去氧胆酸与三甲胺硫酸酐复合物反应,得到熊去氧胆酸3,7-二硫酸盐二三甲基铵反应中间体;b)用有机或无机钠碱处理熊去氧胆酸3,7-二硫酸盐二三甲基铵盐,得到熊去氧胆酸3,7-二硫酸盐三钠盐;c)在异丙醇存在下用无机酸处理至pH在3.0至4.5范围内,以得到熊去氧胆酸3,7-二硫酸盐二钠的溶液;d)去除存在的盐并获得熊去氧胆酸3,7-二硫酸盐二钠。