中国临床药理学杂志2025，Vol.41Issue(5)：747-750,4.DOI:10.13699/j.cnki.1001-6821.2025.05.029
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
司晓菲 1姜典卓1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100076
- 折叠
摘要
Abstract
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Key words
paliperidone/extended-release tablet/generic drug/formulation and manufacturing process development/quality control分类
医药卫生引用本文复制引用
司晓菲,姜典卓..帕利哌酮缓释片仿制药药学研究探究[J].中国临床药理学杂志,2025,41(5):747-750,4.
