医药导报2026，Vol.45Issue(4)：706-710,5.DOI:10.3870/j.issn.1004-0781.2026.04.021
利可君原料药及片剂国家药品标准研究
Study on the Pharmacopoeia Standards for Leucogen and Its Tablets
摘要
Abstract
As a mainstream oral preparation to promote leukocytosis in China,Leucogen is widely used in clinical prac-tice for the prevention and treatment of leukopenia,thrombocytopenia,aplastic anemia and other related conditions.In order to improve drug quality control,Chinese Pharmacopoeia Commission had led the enhancement of the national drug standards for leu-cogen and its tablets,which have been newly included in the 2025 edition of Chinese Pharmacopoeia(Volume Ⅱ).This study focused on analyzing the revision and improvement process of related substances and dissolution tests,and clarified the rationale and procedures behind the enhancement and establishment of the pharmacopoeia standards for leucogen and leucogen tablets,while also providing a reference for the improvement of other drug standards and the establishment of pharmacopoeia standards.关键词
利可君原料药/利可君片/药典标准/质量控制Key words
Leucogen active pharmaceutical ingredient/Leucogen tablets/Pharmacopoeia standards/Quality control分类
医药卫生引用本文复制引用
李海岛,郑萍,岳志华,赵志刚..利可君原料药及片剂国家药品标准研究[J].医药导报,2026,45(4):706-710,5.基金项目
国家药典委员会2019年度国家药品标准提高项目课题(2019H041/2019H042). （2019H041/2019H042）
