杞菊地黄丸HPLC指纹图谱的建立及特征峰的归属分析

Establishment of HPLC Fingerprint of Qiju Dihuang Pill and the Attribution Analysis of Characteristic Peaks

目的建立杞菊地黄丸的HPLC指纹图谱,为科学评价及有效控制杞菊地黄丸的质量提供可靠方法。方法采用CAPCELL PAK MG C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,检测波长225 nm,采集时间80 min。建立指纹图谱,采用中药指纹图谱相似度评价系统对抽取的239批样品进行指纹图谱的相似度评价。结果建立指纹图谱共有23个特征峰,采用对照品和对照药材比对的方法对特征峰进行归属。239批次样品中238批次的指纹图谱与对照指纹图谱的相似度>0.9,相似度良好。结论建立的杞菊地黄丸HPLC指纹图谱可用于制剂的质量控制,为杞菊地黄丸的整体质量评价及控制提供依据。

OBJECTIVE To establish an HPLC fingerprint of Qiju Dihuang pill, and provide an effective and reliable method for the quality evaluation and quality control of Qiju Dihuang pill. METHODS The HPLC fingerprint analysis was carried out on a column of CAPCELL PAK MG C18(250 mm×4.6 mm, 5 μm), using a mobile phase of acetonitrile-0.1% phosphoric acid solution. The detection wavelength was set at 225 nm, and the total run time was 80 min. The control fingerprint was established by similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine, and the similarity of 239 batches of samples was evaluated. RESULTS There were 23 characteristic common peaks in HPLC chromatograms and all the characteristic common peaks were identified by comparison of both the reference substance and the reference herbs. The similarity of the 238 batches in 239 batches of samples was >0.9, and the similarity was good. CONCLUSION The established HPLC fingerprint information of Qiju Dihuang pill can be used for the quality control, and provide a basis for the overall quality evaluation and control of Qiju Dihuang pill.