精神障碍类药物特殊制剂的药学研究思考  

Pharmaceutical considerations on the development ofgeneric special antipsychotic medicines

作　　者：司晓菲 袭辰辰 张仲恒 姜典卓 SI Xiao-fei;XI Chen-chen;ZHANG Zhong-heng;JIANG Dian-zhuo(Centerfor Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2022年第9期840-844,共5页Chinese Journal of New Drugs

摘　　要：化学药物特殊制剂广泛应用于精神障碍类疾病的治疗,成为近期仿制药研发的热点。本文通过对国外审评报告的分析和专利文献的研究等,结合具体的药物案例,综合提出精神障碍类药物特殊制剂的处方工艺、释药机制、原料控制等方面研究的思考。建议考虑临床用药需求进而深入药学研究,以期为精神障碍类特殊仿制药的研发提供更多参考。The special chemical preparations are widely used in the treatment of mental disorders, they have become hotspots in the application of generic drugs in recent years. Based on the analysis of the relevant review reports and literature abroad, by taking specific cases study, some pharmaceutical considerations on the development of generic special antipsychotic medicines, such as formulation and manufacturing process, drug release mechanism and drug substance control are discussed in this article. It’s recommended to take clinical needs into account and conduct further in-depth pharmaceutical studies, in order to provide some reference for the future generic drug research.

关 键 词：精神障碍类仿制药 特殊制剂 释药机制 处方 

分 类 号：R971.4[医药卫生—药品]