| 摘要 |
<p>A method for preparing a risedronate sodium salt anhydride is provided to obtain the stable risedronate sodium salt anhydride in an anhydrous form with high yield and high purity by reacting a 3-pyridyl-1-hydroxyethylidine-1,1-bisphosphonic acid mono-sodium salt 2.5 hydrate with glycol. A method for preparing a stable anhydride of a 3-pyridyl-1-hydroxyethylidine-1,1-bisphosphonic acid mono-sodium salt comprises the steps of: (a) after adding glycol such as PEG(polyethylene glycol) 200, 400, and 600 to 6000 to a 3-pyridyl-1-hydroxyethylidine-1,1-bisphosphonic acid mono-sodium salt 2.5 hydrate in an aqueous solution at a temperature of about 70-85 deg.C, increasing the temperature to 95-110 deg.C; (b) agitating the reaction product obtained from the step(a) at a temperature of 100-170 deg.C for 20-40 minutes; (c) cooling down the reaction product obtained from the step(b) to a temperature of 20-40 deg.C; (d) filtering crystals obtained by cooling; and (e) washing the filtered crystals with C1-3 alcohol.</p> |
