帕利哌酮缓释片仿制药药学研究探究  

Discussion on the pharmaceutical development of paliperidone extended-release tablets

作　　者：司晓菲 姜典卓 SI Xiao-fei;JIANG Dian-zhuo(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国临床药理学杂志》2025年第5期747-750,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：抗精神病药物是治疗精神分裂症的主要药物。帕利哌酮作为第2代非典型抗精神病药物,已被开发为调释制剂帕利哌酮缓释片,有效地应用于精神分裂症的治疗。该缓释片可以一定程度上减少血药浓度波动,提高患者依从性,近年来得到了广泛的关注。本研究通过检索国外相关审评报告和文献,对帕利哌酮缓释片药学研究进行探讨,重点关注处方工艺和质量控制等方面,为其仿制药研究开发提供科学参考和依据。Antipsychotic drugs are the main drugs for the treatment of schizophrenia.Paliperidone is the atypical second-generation antipsychotic(SGA)that has been developed as extended-release(ER)tablets.They have been used effectively in the treatment of schizophrenia,which can reduce the fluctuation of blood drug concentration and improve patient compliance to some extent.Based on literature investigation,the pharmaceutical considerations were put forward in terms formulation,manufacturing process and quality control,aimed to provide scientific reference for research and development of paliperidone extended-release tablets.

关 键 词：帕利哌酮 缓释片 仿制药 处方工艺 质量控制 

分 类 号：R971[医药卫生—药品]