银杏叶制剂指纹图谱的研究及其应用(英文)

Study and Application of Fingerprints of Ginkgo biloba Leaves Preparations

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 ,以DiamonsilTMC18(2 0 0mm× 4 . 6mm ,5 μm)柱为分析柱 ;CH3 CN 0 .0 1mol·L-1KH2 PO4缓冲液 (pH 2 )为流动相 ,梯度洗脱 ,柱温 2 4℃。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。

Aim To establish a method for determination of Ginkgo biloba L, its extractand preparations with HPLC fingerprints, so as to control the quality of the preparations. MethodsHPLC-DAD method was used to determine the constituents in preparations. Diamonsil? C_(18) (200mm X 4.6 mm, 5 μm) was used as analytical column, and acetonitrile/KH_2PO_4 was used as mobilephase with gradient elu-tion. The column temperature was at 24 ℃. The HPLC profile of chemicalconstituents of control sample and preparations were analyzed using similarity software. Results Thefingerprints of different preparations from different companies were slightly different because ofthe different preparing procedures. Mean while, the fingerprints of different batches of the samepreparation from the same company were similar to each other and the technology of each preparationwas stable. Conclusion This method is accurate, reproducible , simple, and can be used as ananalytical method for the routine quality control of Ginkgo biloba preparations.