Study On The Preparation Technology And Quality Of Donepezil Hydrochloride Tablets

As one of the central nervous system degenerative diseases, the pathogenesis of Alzheimer’s disease (AD) is partially associated with defficiency of cholinergic neurotransmission. The second generation of central acetylcholinesterase (AchE) inhibitors-Donepezil hydrochloride exerts a therapeutic action by enhancing the function of cholinergic neurotransmission. It can be reversible to inhibit AchE for the hydrolysis of acetylcholine, so as to improve the concentration of acetylcholine. It is a highly selective and reversible drug for AD.Japan eisai pharmaceutical co, independently developed donepezil HCL, at the same time cooperated with Pfizer for the development of the global market. In November 1996, donepezil HCL was used for clinical purposes as Aricept(?)approved by FDA. Aricept(?)has been promoted in more than 100 countries around the world since 1997. In October 1999, SFDA approved Aricept(?)registered in China. At present, listed drugs and specifications (5 mg,10 mg) are only used for mild or moderate AD patients. To relieve the symptoms of moderate or severe AD patients, our company developed donepezil hydrochloride tablets (23 mg).This article focuses on screening process and quality control study. Mass production of 23 mg specifications of Donepezil hydrochloride piece was used to treat moderate or severe Alzheimer’s disease symptoms.(1)The appropriate concentration and dosage of the donepezil hydrochloride tablets were defined by studying release agents, fillers and binders refered to the original research.(2) Screening the effect of the drying process conditions on the preparation process and quality to determine suitable drying process.(3) The prescription process of the donepezil hydrochloride tablets was further screened and optimized to determine the best formulation.(4) Reference documents and relevant materials, the quality of donepezil HCL methodology research, standards and quality control.