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银杏叶制剂指纹图谱的研究及其应用

徐亚萍, 姚彤炜*   

  1. 浙江大学药学院药物分析与药物代谢研究室, 浙江 杭州 310031
  • 收稿日期:2004-11-08 修回日期:2005-02-10 出版日期:2005-03-15 发布日期:2005-03-15
  • 通讯作者: 姚彤炜*

Study and Application of Fingerprints of Ginkgo biloba Leaves Preparations

XU Ya-ping, YAO Tong-wei*   

  1. Department of Pharmaceutical Analysis and Drug Metabolism, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310031, China
  • Received:2004-11-08 Revised:2005-02-10 Online:2005-03-15 Published:2005-03-15
  • Contact: YAO Tong-wei*

摘要: 目的 建立银杏叶提取物及其制剂的HPLC指纹图谱分析方法. 方法 应用HPLC-DAD法检测银杏叶提取物和制剂中主要化学成分, DiamonsilTM C18(200 mm×4.6 mm, 5 μm)柱为分析柱; CH3CN-0.01 mol·L-1 KH2PO4缓冲液(pH 2)为流动相, 梯度洗脱, 柱温24 ºC. 分析测定了不同制剂和银杏叶对照提取物的指纹图谱, 应用相似度计算软件, 对银杏叶对照提取物与各种制剂的整体化学成分信息进行分析. 结果 来自不同厂家的不同制剂的指纹图谱有差异, 但来自不同厂家不同批次的提取物的指纹图谱差别不大, 同一厂家生产的不同批号的同一种制剂的指纹图谱也十分相似, 这些结果表明不同制剂因制备工艺的不同造成指纹图谱的差异, 但每种银杏叶制剂的指纹图谱非常相似, 说明银杏叶制剂生产工艺稳定, 质量恒定. 结论 本方法精确、简便、重复性好, 可用于各种银杏叶制剂的质量控制.

关键词: 银杏叶, 银杏叶, 银杏叶, 高效液相色谱法, 高效液相色谱法, 高效液相色谱法, 指纹图谱, 指纹图谱, 指纹图谱, 相似度, 相似度, 相似度

Abstract: Aim To establish a method for determination of Ginkgo biloba L, its extract and preparations with HPLC fingerprints, so as to c ontrol the quality of the preparations. Methods HPLC-DAD method was used to determine the constituents in preparations. Diamonsil TM C18(200 mm×4.6 mm, 5 μm) was used as analytical column, and acetonitrile/KH2PO4 was used as mobile phase with gradient elution. The column temperatu re was at 24 ºC. The HPLC profile of chemical constituents of control sample and preparations were analyzed using similarity software. Results The fingerprints of different preparations from different companies were slightl y different because of the different preparing procedures. Mean while, the finge rprints of different batches of the same preparation from the same company were similar to each other and the technology of each preparation was stable. Conclusion This method is accurate, reproducible, simple, and can be used as an analytical method for the routine quality control of Ginkgo biloba preparations.

Key words: Ginkgo biloba, Ginkgo biloba, high-performance liquid chroma tography, high-performance liquid chroma tography, fingerprints, fingerprints, similarity, similarity

中图分类号: 

Supporting: Foundation item:Zhejiang Province Natural Science Foundation of China (No. 302682) . Science and Technology Department of Zhejiang Province Foundation (No. 2004C3009), Economic &Trade Commission of Zhejiang Province Foundation, and Doctoral discipline Foundation, Ministry of Education of China (No. 20040335013).
*Corresponding author. Tel.: 86-571-87217203