银杏叶质量标准的对比分析  

Contrastive analysis of quality standards of ginkgo leaves

作　　者：周云鸿 王军 ZHOU Yunhong;WANG Jun(Shanghai TCM Co.,Ltd.,Shanghai 200082,China;SPH Xingling Sci.&Tech.Pharmaceutical Co.,Ltd.,Shanghai 201703,China)

机构地区：[1]上海市药材有限公司,上海200082 [2]上海上药杏灵科技药业股份有限公司,上海201703

出　　处：《上海医药》2020年第15期109-114,共6页Shanghai Medical & Pharmaceutical Journal

摘　　要：对比分析了《中国药典》2015年版、《美国药典》第41版、《欧洲药典》第9.0版中银杏叶质量标准的异同,其中上海上药杏灵科技药业股份有限公司所执行的企业标准总黄酮醇苷≥0.80%,萜类内酯≥0.40%,限度标准最为严格;而USP41在定性鉴别项下检查项目最为详细,采用了高效薄层色谱法(HPTLC)。上药杏灵针对银杏叶所制定执行的质量标准大部分项目处于较高水平,为行业良性发展和临床安全用药提供了保障。The similarities and differences between Xingling’s corporate standard and the Chinese Pharmacopoeia, the United States Pharmacopoeia and the European Pharmacopoeia were analyzed. The results showed that the corporate standard for the total flavonol glycosides( ≥0.80%) and terpenoids( ≥0.40%) implemented by Xingling was the strictest in limit criteria and USP41 had the most detailed inspection items under qualitative identification, using high-performance thin-layer chromatography(HPTLC). Most of the effective ingredient content quality standards formulated and implemented by Xingling for Ginkgo biloba were at a high level, which can provide a guarantee for the benign development of the industry and the clinical safety of drug use.

关 键 词：银杏叶 质量标准 总黄酮醇苷 萜类内酯 

分 类 号：R286[医药卫生—中药学] R921[医药卫生—中医学]