精神障碍类治疗药物口腔膜剂药学研究探究  

Pharmaceutical research on the oral soluble film for the treatment of mental disorders

作　　者：司晓菲 姜典卓 SI Xiao-fei;JIANG Dian-zhuo(Center for 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：《临床药物治疗杂志》2023年第5期1-6,共6页Clinical Medication Journal

摘　　要：精神障碍类治疗药物口腔膜剂成为国内近期药物研发的热点。部分口腔膜剂可以一定程度上提高患者依从性,有良好的临床治疗效果和安全性,为临床提供更多的治疗选择。通过检索相关国外审评报告和文献资料,概述国内外上市(包括中国、美国、欧洲和日本)和注册申报的治疗精神障碍化学药品口腔膜剂情况,并结合治疗精神障碍代表性药物实例(如奥氮平口溶膜、多奈哌齐口溶膜等),从审评角度对此类药物的药学研究关注点进行探究。提出加强处方工艺和质量控制等研究的考虑,需关注原料药理化性质对制剂质量的影响,并结合膜剂和产品特性进行全面药学研究。从而为精神障碍类治疗药物口腔膜剂的研究开发和技术评价提供一定的参考。The oral soluble film for the treatment of mental disorders has become the hot spots in drug research and devel⁃opment in recent years.Some oral soluble films have been demonstrated therapeutic effectiveness and good drug safety,which can improve patient compliance to some extent and provide more treatment options for clinical use.By searching foreign drug evaluation reports and literatures,this review summarizes the situation of oral soluble film formulationsfor the treatment of men⁃tal disorders listed at the domestic and aboard(including China,the United States,Europe and Japan)and registered,com⁃bined with representative drug examples(such as olanzapine oral soluble film,donepezil hydrochloride oral soluble film,etc.).This article explores the pharmaceutical.This paper proposes the consideration of strengthening the research on formu⁃lating,manufacturing process and quality control,and to conduct a comprehensive pharmaceutical research in combination with film and product characteristics,and the properties of active pharmaceutical ingredients(API)which may affect the quality of formulations.It provides references for drug research and development and the technical evaluation of oral soluble film.

关 键 词：精神障碍类药物 口腔膜剂 处方工艺 质量控制 药学研究 

分 类 号：R95[医药卫生—药学] R971.4