银杏叶提取物质量标准比较及标准提高思路探讨  

Comparison of different specifications of Ginkgo Biloba Extract and discussion on specification improvement

作　　者：唐溱 姜典卓 赵晓霞 张永文[1] TANG Zhen;JIANG Dianzhuo;ZHAO Xiaoxia;ZHANG Yongwen(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国药品标准》2020年第1期21-25,共5页Drug Standards of China

摘　　要：银杏叶提取物(GBE)及其制剂在国内外广泛用于治疗心脑血管疾病。作者通过比较各国药典中GBE质量标准,对不同国家标准中的主要检测指标进行比较,并进一步与另一种GBE—银杏酮酯(GBE50)质量标准作对比分析。在此基础上,作者对GBE质量标准提高思路进行了探讨,目的为提高GBE的质量可控性,也为类似的天然药物提取物质量标准内容的选择提供参考。Ginkgo biloba extract(GBE)and its preparations are world-widely used in the treatment of cardiovascular and cerebrovascular diseases.The GBE monographs in the different pharmacopoeias were compared,and the main test indices in these monographs were compared.The further comparison analysis was made with another ginkgo biloba extract(GBE50).On the basis of the comparison analysis,the proposals on specification improvement of GBE were discussed.That helps improve the quality control of GBE and provide the reference for specifications establishment of other similar natural extracts.

关 键 词：银杏叶提取物 质量研究 质量标准提高 

分 类 号：R921.2[医药卫生—药学]