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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。
Objective To establish a method for the HPLC fingerprinting of Ginkgo biloba extract and its preparations. Methods The main chemical components of Ginkgo biloba extract and its preparations were detected by HPLC DAD method. DiamonsilTM C18 (200 mm×4.6 mm, 5 μm) column was used as the analytical column; CH3 CN 0·0 1 mol·L-1KH2 PO4 buffer ( pH 2 ) as mobile phase, gradient elution, column temperature 24°C. The fingerprints of different preparations and control extracts of Ginkgo biloba were analyzed and determined. The similarity calculation software was used to analyze the chemical composition information of Ginkgo biloba extract and various preparations. Results The fingerprints of different preparations from different manufacturers are different, but the fingerprints of extracts from different manufacturers in different batches are not much different. The fingerprints of the same preparation with different batch numbers produced by the same manufacturer are also very similar. These results show that Different preparations caused differences in fingerprints due to different preparation processes, but the fingerprints of each ginkgo leaf preparation were very similar, indicating that the production process of Ginkgo biloba leaf preparation is stable and the quality is constant. Conclusion The method is accurate, simple, and reproducible, and can be used for quality control of various ginkgo leaf preparations.