医药导报2025，Vol.44Issue(11)：1773-1778,6.DOI:10.3870/j.issn.1004-0781.2025.11.008
2025年版《中华人民共和国药典》光散射法测定粒度通则修订与应用
Revision and Application of the General Rule for Particle Size Analysis by Light Scattering in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
摘要
Abstract
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.关键词
中华人民共和国药典/光散射法/粒度/修订Key words
The Pharmacopoeia of the People's Republic of China/Light scattering method/Particle size/Revision分类
医药卫生引用本文复制引用
吴慧,张宝喜,郑萍,杨永健,薛巧如,陆益红,陈雪帆,谢兰桂,赵霞..2025年版《中华人民共和国药典》光散射法测定粒度通则修订与应用[J].医药导报,2025,44(11):1773-1778,6.基金项目
国家药典委员会2023年度国家药品标准制修订研究课题(2023Y05) （2023Y05）
药品监管科学全国重点实验室课题"新型雾化装置和仿生技术在吸入液体制剂中的研究及应用"(2024SKLDRS0213). （2024SKLDRS0213）
