口腔黏膜给药制剂质量评价要点及标准现状  

Key points and standard status of quality evaluation of oromucosal drug delivery preparations

作　　者：杨柳榴 李铭岩 张隽齐 王兵[1] 尚悦[2] 陈芳[1] YANG Liuliu;LI Mingyan;ZHANG Junqi;WANG Bing;SHANG Yue;CHEN Fang(National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国医药工业研究总院医药先进制造国家工程研究中心,上海201203 [2]国家药典委员会,北京100061

出　　处：《中国药品标准》2024年第3期220-226,共7页Drug Standards of China

基　　金：国家药典委员会2021年度国家药品标准制修订研究课题项目“膜剂通则修订”(2021Y29)。

摘　　要：口腔黏膜给药制剂具有给药方便、利于吞咽困难的患者、快速起效和避免肝脏首过效应等优点。《中国药典》2020年版、EP11.0、BP2022、USP44-NF39、JP18均收载了对不同口腔黏膜给药制剂进行质量控制的相关标准。本文比较了不同国家收载的口腔黏膜制剂通则的差异,并对国内外上市及药典收载的口腔黏膜制剂检查项目进行梳理。国外药典收载的口腔黏膜给药制剂品种较多,对作用于全身的口腔黏膜给药制剂的质量控制更为精细,可为我国对口腔黏膜给药制剂标准的完善和提高提供参考。Oromucosal drug delivery preparations offer advantages such as convenient administration,suitability for patients with dysphagia,rapid onset of action,and avoidance of first-pass metabolism in the liver.The 2020 edition of the Chinese Pharmacopoeia,EP 11.0,BP 2022,USP 44-NF 39,and JP 18 all include relevant standards for the quality control of different oromucosal drug delivery systems.This article compares the differences in general requirements for oromucosal formulations among different countries and provides an overview of inspection items for marketed oral mucosal formulations and those documented in pharmacopoeias both domestically and internationally.Foreign pharmacopoeias include a wide range of oromucosal drug delivery formulations,with more refined quality control measures for systemic action.These findings can serve as a reference for the improvement and enhancement of standards for oromucosal drug delivery systems in China.

关 键 词：口腔黏膜给药制剂 中国药典 欧洲药典 英国药典 美国药典 日本药局方 

分 类 号：R921.2[医药卫生—药学]