PROCESS FOR PREPARING CRYSTALLINE FORM I OF DONEPEZIL HYDROCHLORIDE SALT

摘要

PURPOSE: A method for preparing donepezil hydrochloride crystalline type I is provided to ensure long term-efficient drug expression. CONSTITUTION: A method for preparing donepecil hydrochloride crystalline type I comprises: a step of dissolving donepezil glass base in an organic solvent to prepare a donepezil solution; a step of adding tartaric acid to the solution for precipitating donepezil tartrate; a step of reacting the donepezil tartrate with an inorganic alkaline solution; a step of concentrating an organic layer; a step of adding hydrochloric acid-methanol solution to the concentrate to form donepezil hydrochloride; and a step of crystallizing the donepezil hydrochloride.