中国药典膜剂通则修订的考量
Considerations for the Revision of General Requirements of Pharmaceutical Films in the General Chapter of the Chinese Pharmacopoeia
陈芳 1王健 1李铭岩 1尚悦 2侯惠民1
作者信息
- 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
- 折叠
摘要
膜剂系指采用流延或挤出等方法将药物分散在成膜材料中制备的薄膜状制剂,由于给药方便、患者依从性好,近年来发展迅速,日益受到关注.该文梳理了上市的膜剂品种及其质量标准和贮存要求,调研了膜剂溶化时限和溶出度等质量检查项目的测定方法,结合《美国药典》《欧洲药典》和《日本药局方》要求,对《中华人民共和国药典》膜剂通则的修订做简要说明.
Abstract
The pharmaceutical films are thin sheets formed by various methods such as casting or extrusion,which results in a dispersion of the active pharmaceutical ingredients through the film.They are subject to growing re-search and have received increasing interests recently due to their convenient administration and improved patient com-pliance.This review summarizes the marketed products of film dosage form,their quality standards,and storage requirements.Besides,the testing methods of quality inspection items including disintegration time and dissolution are discussed.Finally,brief explanations are provided for the revision of general requirements of pharmaceutical films in the general chapter of the Chinese Pharmacopoeia by comparing with the United States Pharmacopoeia,European Pharmacopoeia,and Japanese Pharmacopoeia.
关键词
膜剂/质量标准/中华人民共和国药典/通则/修订Key words
pharmaceutical film/quality standard/Chinese Pharmacopoeia/general chapter/revision引用本文复制引用
基金项目
国家药典委员会国家药品标准制修订研究课题(2021)(2021Y29)
出版年
2024
NETL
NSTL
万方数据