药学研究2026，Vol.45Issue(2)：182-187,6.DOI:10.13506/j.cnki.jpr.2026.02.010
化学仿制药复方双层片处方工艺开发一般考虑
General considerations for the prescription and process development of chemical generic compound bilayer tablets
率亚平 1赵娜 1孙元朋 1谢琰 1章俊麟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
Compound bilayer tablets have been widely concerned in the development of novel solid formulations because of its advantages including enhancing drug efficacy,reducing side effects and improving patient compliance by combining medications or adjusting the rate of drug release.This review summarized the key points in prescription screening and process development of chemical generic compound bilayer tablets,combining the literature patents,relevant domestic and foreign drug laws and regulations.This included the characteristics of active pharmaceutical ingredients,the selection of ex-cipients,the design of multi-strengths prescription,the development of bilayer process and batch amplification,etc.,in order to provide a reference for generic compound bilayer tablets drug development.关键词
复方双层片/粒径分布/处方工艺开发Key words
Compound bilayer tablets/Particle size distribution/Prescription and process development分类
医药卫生引用本文复制引用
率亚平,赵娜,孙元朋,谢琰,章俊麟..化学仿制药复方双层片处方工艺开发一般考虑[J].药学研究,2026,45(2):182-187,6.
