阿立哌唑智能制剂和长效注射剂的药学研究探究
Discussion on the pharmaceutical development of digital medicine and long-acting injections of aripiprazole
司晓菲 1唐谦 2袭辰辰 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
- 2. 浙江省药品化妆品审评中心,浙江杭州 310012
- 折叠
摘要
阿立哌唑已广泛应用于精神分裂症的治疗,其智能制剂和长效注射剂的开发可以在一定程度上提高患者依从性,近年来得到了广泛的关注.本研究通过检索相关国外审评报告和文献,结合《第三批鼓励仿制药品目录》中阿立哌唑长效注射剂收录情况,分析了国内外上市的阿立哌唑智能制剂和长效注射剂,对其药学研究进行探讨,重点关注处方工艺和质量控制等研究,为其仿制药研究开发提供科学参考和依据.
Abstract
Aripiprazole drug products have been used widely for treatment of schizophrenia.The digital medicine and long-acting injections of aripiprazole have received widespread attention in recent years,which can improve patient compliance to some extent.Based on literature investigation,combined with analysis long-acting injections of aripiprazole in China'Encourage generic drug catalogue(third batch)',the approval cases were summarized,and the pharmaceutical considerations were put forward in terms formulation,manufacturing process and quality control,aimed to provide scientific reference for research and development of such drugs.
关键词
阿立哌唑/智能制剂/长效注射剂/鼓励仿制药品目录/处方工艺/质量控制/药学研究Key words
aripiprazole/digital medicine/long-acting injection/China encourage generic drug catalogue/formulation and manufacturing process development/quality control/pharmaceutical research引用本文复制引用
基金项目
浙江省软科学研究计划(2023C35G1481898)
出版年
2024
国家科技期刊平台
NSTL
万方数据