不同生产批次的银杏叶提取物注射液质量分析  

Quality Analysis of Ginkgo Biloba Extract Injection from Different Production Batches

作　　者：黄财顺 萧绮珊 赖昌威 陆璐璐 郑文燕 Huang Caishun;Xiao Qishan;Lai Changwei;Lu Lulu;Zheng Wenyan(Zhongshan Institute for Food and Drug Control,Zhongshan,Guangdong 528400,China;Center for ADR Monitoring of Zhongshan,Zhongshan,Guangdong 528400,China)

机构地区：[1]中山市食品药品检验所,广东中山528400 [2]中山市药品不良反应监测中心,广东中山528437

出　　处：《化工与医药工程》2023年第5期29-33,共5页Chemical and Pharmaceutical Engineering

基　　金：广东省药品监督管理局科技项目(No:2022TDB20)。

摘　　要：对收集的4批次银杏叶提取物注射液进行多项目测定,对其质量进行分析与评价。参照国家药品标准YBH02612007及国家药品监督管理局药品补充检验方法的公告(2015年第142号)进行检验,比较了性状、鉴别、pH值、乙醇量、补充检验方法下的游离槲皮素、山奈素、异鼠李素、含量测定等项目,对检验结果进行统计分析和评价。4批次检验结果均符合标准要求,合格率为100%,但存在一定差异。不同批次银杏叶提取物注射液质量存在差异,有关制剂的原辅料、处方和制剂工艺等还具有很大的改进空间。4 batches of ginkgo biloba injection were collected for multi-item determination,and the quality of products from different batches was analyzed and evaluated.According to National Drug Standards of YBH02612007 and supplementary testing methods of the State Drug Administration(No.142 of 2015),the properties,identification,pH,amount of ethanol,Free quercetin,Kaempferol,isorhamnetin and content determination of products from different batches were compared,and the test results were statistically analyzed and evaluated.The test results of 4 batches were all in line with the standard,and the qualified rate was 100%,but there were some differences.The quality of folic acid tablets from different batches is different,and there is still a lot of room for improvement in the raw materials,prescription and preparation process of Ginkgo biloba extract injection.

关 键 词：银杏叶提取物 不同批次 质量 

分 类 号：R284.1[医药卫生—中药学]