| 引用本文: | 黄琴伟,郑成,赵维良,张文婷,马临科.中国药典2015年版银杏叶提取物及相关制剂质量标准修订概况[J].中国现代应用药学,2016,33(5):615-618. |
| HUANG Qinwei,ZHENG Cheng,ZHAO Weiliang,ZHANG Wenting,MA Linke.Revision of Ginkgo Leaves Extract and Preparations in Chinese Pharmacopoeia (2015 Edition)[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(5):615-618. |
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| 摘要: |
| 目的 介绍中国药典2015年版中银杏叶提取物及相关制剂质量标准的修订情况。方法 简述中药质量控制和评价的新技术及其在中国药典 2015 年版银杏叶提取物及相关制剂(银杏叶片、胶 囊、滴丸)质量标准修订中的应用情况。结果 将一测多评方法和对照提取物应用于相关质量标准，相应地修订了黄酮醇苷和萜类内酯的含量测定，修订了银杏酸检查方法。结论 修订的质量标准可更有效的控制制剂的质量。 |
| 关键词: 中国药典2015年版 银杏叶提取物 银杏叶制剂 修订 |
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| 基金项目:国家药品标准提高暨2015年版药典科研任务；浙江省食品药品监管系统科技计划项目(2014005) |
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| Revision of Ginkgo Leaves Extract and Preparations in Chinese Pharmacopoeia (2015 Edition) |
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HUANG Qinwei, ZHENG Cheng, ZHAO Weiliang, ZHANG Wenting, MA Linke
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Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To introduce revision of Ginkgo leaves extract and preparations in Chinese Pharmacopoeca (2015 Edition). METHODS To introduce the new analysis technologies for the quality control of traditional Chinese medicines and to describe the revision of Ginkgo leaves extract and preparations in Chinese Pharmacopoeia 2015. RESULTS QAMS and reference extract had been applied in determining the assay of total flavonol glycosides and terpene lactones, respectively. Total ginkgolic acids had been revised. CONCLUSION Revised quality standards can be used for more?effective?control?of Ginkgo leaves extract and preparations. |
| Key words: Chinese Pharmacopoeia (2015 Edition) Ginkgo leaves extract Ginkgo leaves preparations revision |
