化学药品口崩片药学研究关注点探讨  

Discussion on pharmaceutical research concerns of chemicalorally disintegrating tablets

作　　者：张钊瑞 胡延臣 ZHANG Zhaorui;HU Yanchen(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药学研究》2025年第4期359-363,共5页Journal of Pharmaceutical Research

摘　　要：口崩片系指在口腔内不需要用水即能迅速崩解或溶解的片剂。口崩片作为片剂剂型之一,具有服用方便、在口腔内迅速崩解或溶解等优势,有助于改善患者用药依从性。本文结合口崩片相关指导原则、药典标准及上市药品情况,对口崩片处方工艺、质量研究和质量控制、稳定性和包装等方面进行探讨。希望有助于口崩片的开发,期待更多高质量口崩片上市,满足特定患者的用药需求。Orally disintegrating tablets are tablets that can disintegrate or dissolve quickly without water in the mouth.As one of the dosage forms of tablets,orally disintegrating tablets have the advantages of easy to take,rapid disintegration or dissolution in the mouth,which is helpful to improve the patients compliance.Discussions on formulation and manufacturing process,quality research and quality control,stability and packaging of orally disintegrating tablets were based on the marketing drug,pharmacopoeia standards and guiding principles at home and abroad.These discussions are expected to guide the development of orally disintegrating tablets,and promote marketing of high-quality orally disintegrating tablets to meet the needs of specific patients.

关 键 词：口崩片 处方工艺 质量控制 稳定性和包装 新药注册 

分 类 号：R943[医药卫生—药剂学]