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

    Revision of Ginkgo Leaves Extract and Preparations in Chinese Pharmacopoeia (2015 Edition)

    • 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。

       

      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.

       

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