银杏叶提取物及其制剂指纹图谱和掺伪检验方法的建立

Establishment of the fingerprints and adulteration inspection method of Ginkgo Folium extract and its preparations

目的建立银杏叶提取物及其制剂的指纹图谱和掺伪检验方法。方法高效液相色谱-二极管阵列检测器(HPLC-DAD)法建立指纹图谱。分析采用Agilent Eclipse C18色谱柱(4.6 mm×150 mm,5μm);以乙腈-0.1%甲酸为流动相,梯度洗脱;体积流量1.0 m L/min;检测波长254 nm和360 nm。以银杏叶提取物为对照,360 nm波长下对指纹图谱进行检测,计算相似度。根据254 nm和360 nm指纹图谱及紫外光谱信息,研究掺伪情况。结果 300批样品中,游离黄酮苷元合格(正规工艺生产)的239批相似度均大于0.80,其余均小于0.80,62批样品中非法掺入了槐角苷。结论该方法简便、重复性好、专属性强,可为银杏叶提取物及其制剂的质量控制提供技术依据。

AIM To establish the fingerprints and adulteration inspection method of Ginkgo Folium extract and its preparations. METHODS The fingerprints were established by high-performance liquid chromatography-diode array detector（ HPLC-DAD）. The analysis was performed on Agilent Eclipse C18column（ 4. 6 mm × 150 mm,5 μm）,mobile phase was acetonitrile-0. 1% acetic acid for gradient elution,flow rate was 1. 0 m L / min,and detection wavelengths were set at 254 nm and 360 nm. With Ginkgo Folium extract as a reference,the fingerprints were detected at 360 nm,whose similarties were calculated. According to the information of fingerprints and ultraviolet spectra at 254 nm and 360 nm,the adulteration was studied. RESULTS In 300 batches of samples,the similarities of 239 batches with qualified free flavonoid aglycones（ produced by regular process） were more than0. 80,while the others were less than 0. 80. Sixty-two batches of samples were illegally added with sophoricoside.CONCLUSION This method is simple,reproducible and specific,which can provide the technical basis for quality control of Ginkgo Folium extract and its preparations.