非口服缓控释制剂在精神分裂症治疗中的应用及其研发的一般思考  

The application of non-oral modified release preparation in the treatment of schizophrenia and general consideration for its research and development

作　　者：刘孟斯 韩鸿璨 孙春萌[2] LIU Meng-si;HAN Hong-can;SUN Chun-meng(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;National Medical Products Administration Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients,Center for Research,Development and Evaluation for Pharmaceutical Excipients and Generic Drugs,China Pharmaceutical University,Nanjing 210009,Jiangsu Province,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]国家药品监督管理局药物制剂及辅料研究与评价重点实验室,中国药科大学药用辅料及仿创药物研发评价中心,江苏南京210009

出　　处：《中国临床药理学杂志》2021年第10期1255-1260,1265,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：精神分裂症属于慢性精神障碍,通常患者服药依从性差,且需要相对长期的治疗以防止复发。以长效注射剂与透皮贴剂为代表的非口服缓控释制剂是近年来开发的用于精神分裂症治疗的新剂型,相较于普通口服剂型,其具有给药频次少、利于提高长期治疗的依从性以及避免患者自行藏药影响治疗等明显优势,且为临床治疗方案提供了更多选择。本文就近年来国内外在精神分裂症治疗中使用的非口服缓控释制剂进行了综述,介绍了其作用机制及临床优势,对其制备工艺、药学特点及临床研究要求进行了简要讨论。Schizophrenia is a chronic mental disorder. Usually, patients have poor medication compliance and require relatively long-term treatment to prevent recurrence. Non-oral modified release preparation, including Long-acting injection and transdermal patch, emerges as a new dosage form developed in recent years for schizophrenia. Compared with ordinary oral dosage form, the non-oral dosage has significant advantages such as less dosing frequency, which helps to improve the compliance of long-term treatment, preventing patients from concealing the medication and thus affecting treatment, and providing more options for clinical treatment protocols. This paper reviews the advances on the non-oral modified-release preparations for schizophrenia treatment in recent years, describes their mechanisms of actions and clinical advantages, and briefly discusses their preparation processes, pharmaceutical characteristics and clinical research requirements.

关 键 词：精神分裂症 非口服缓控释制剂 药学研发 临床研究要求 

分 类 号：R95[医药卫生—药学]