茵栀黄颗粒的HPLC指纹图谱研究及共有峰归属分析

目的：建立茵栀黄颗粒的HPLC指纹图谱，并对其共有峰进行归属分析和指认，以科学评价及有效控制该制剂质量。方法：采用Kromasil C₁₈（4.6 mm×250 mm，5 μm）色谱柱，流动相为乙腈（A）-0.1%磷酸水溶液（B），梯度洗脱，流速1.0 mL·min^-1，检测波长238 nm，柱温30℃。测定20批茵栀黄颗粒样品指纹图谱，建立共有模式，并采用《中药色谱指纹图谱相似度评价系统》（2004A版）进行相似度评价；通过与各对照品保留时间比对，对共有峰进行归属分析和确认。结果：以栀子苷峰为参照峰，建立了茵栀黄颗粒的HPLC指纹图谱，确定了29个共有峰，并对其中的16个色谱峰进行了指认及归属。20批茵栀黄颗粒样品指纹图谱经相似度评价，其相似度均大于0.95。结论：该法所建立的指纹图谱能较全面地体现茵栀黄颗粒中组分的整体特征，为茵栀黄颗粒的质量控制提升提供了依据。

Study on HPLC fingerprints of Yinzhihuang granules and attributive analysis of their common peaks

OBJECTIVE To establish HPLC fingerprints of Yinzhihuang Granules and to analyze and identify their common peaks in order to scientifically evaluate and effectively control the quality of the preparation.METHODS A Kromasil C₁₈ (4.6 mm×250 mm, 5 μm) column was used with a mobile phase of acetonitrile (A) -0.1% aqueous phosphoric acid (B), gradient elution, flow rate of 1.0 mL·min^-1, detection wavelength of 238 nm, and column temperature of 30℃. Fingerprints of 20 batches of Yinjiehuang Granules were determined to establish a common pattern, and the similarity evaluation was performed using the Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine (Version 2004A); the common peaks were assigned and confirmed by comparison with the retention time of each reference substance. RESULTS The HPLC fingerprint of Yinzhihuang granules was established with geniposide as reference peak. 29 common peaks were identified and 16 peaks were assigned. The fingerprints of 20 batches of Yinzhihuang granule samples were evaluated by similarity and all of which exceeded 0.95.CONCLUSION The established HPLC fingerprint can reflect the overall characteristics of Yinzhihuang Granules with good precision, stability and repeatability, which provides a basis for improving the quality control of Yinzhihuang Granules.