银杏叶片及银杏叶胶囊的质量分析及建议  

Quality Analysis and Suggestion for Ginkgo Folium Tablets and Ginkgo Folium Capsules

作　　者：刘丽娜[1] 金红宇[1] 李耀磊[1] 许玮仪[1] 王莹[1] 昝珂[1] 马双成[1] LIU Li-na;JIN Hong-yu;LI Yao-lei;XU Wei-yi;WANG Ying;ZAN Ke;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国实验方剂学杂志》2021年第1期147-153,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家“重大新药创制”科技重大专项(2018ZX09303-024)。

摘　　要：目的:比较目前市场上不同厂家的银杏叶片及银杏叶胶囊样品,对质量差异进行分析,并对二者的质量标准提高和市场监管提出建议。方法:按照2015年版《中国药典》(一部)银杏叶片及银杏叶胶囊含量测定项方法测定了银杏叶片及银杏叶胶囊中总黄酮醇苷及萜类内酯的含量,按照国家药品监督管理局发布的银杏叶片及银杏叶胶囊相关补充检验方法,对银杏叶片及银杏叶胶囊中游离黄酮(槲皮素、山柰素、异鼠李素)及槐角苷检查项进行了测定,并对48家企业生产的328批银杏叶片及银杏叶胶囊的总黄酮醇苷、萜类内酯含量测定项以及游离黄酮、槐角苷检查项进行分析,比较不同批次及不同厂家银杏叶制剂的质量差异。结果:328批银杏叶片及银杏叶胶囊质量均符合标准规定,但总黄酮醇苷及萜类内酯含量分布范围均较宽,不同企业间样品质量差异较大。结论:建议各企业对工艺进行优化,对原材料进行严格控制,以保证样品的批间一致性。Objective: To conduct quality evaluation of Ginkgo Folium preparations by analyzing the national evaluation sampling test results,analyze the quality differences,and put forward suggestions for the improvement of quality standards and market supervision. Method: The contents of total flavonol glycosides and terpene lactones in Ginkgo Folium tablets and Ginkgo Folium capsules were determined according to the methods of determination in the 2015 edition of Chinese Pharmacopoeia(the first volume),and the contents of free flavonoids(quercetin,kaempferide and isorhamnetin)and sophoricoside in Ginkgo Folium preparations were determined according to related supplementary testing method of Ginkgo Folium tablets and Ginkgo Folium capsules issued by National Medical Products Administration. The quality differences of Ginkgo Folium preparations from different batches and different manufacturers were compared according to the contents of total flavonol glycosides,terpene lactones,free flavonoids and sophoricoside in 328 batches of Ginkgo Folium tablets and Ginkgo Folium capsules manufactured by 48 enterprises. Result: Quality of 328 batches of Ginkgo Folium tablets and Ginkgo Folium capsules was in accordance with the standard,but the contents of terpene lactones and total flavonol glycosides were all distributed in a wide range,and the quality of samples varied greatly among different enterprises. Conclusion: It is recommended that each enterprise should optimize the production process and strictly control the raw materials to ensure the consistency between different batches of samples.

关 键 词：银杏叶片 银杏叶胶囊 质量评价 萜类内酯 槐角苷 游离黄酮 黄酮醇苷 

分 类 号：R22[医药卫生—中医基础理论] R9[医药卫生—中医学]