目的 建立坤宁颗粒HPLC指纹图谱，为其质量控制提供依据。方法 采用Kromasil 100-5 C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相为乙腈-0.1%磷酸溶液，梯度洗脱；体积流量：1.0 mL/min；检测波长0~12 min为280 nm，12~55 min为230 nm；柱温：30℃；进样量：10 μL。对指纹图谱共有峰进行指认，分析相似度，并考察了药材与制剂的相关性。结果 测定了10批坤宁颗粒，选择柚皮苷作为参照物，提取14个色谱峰作为指纹图谱共有峰，并将共有峰归属到各药材；10批样品相似度均大于0.95。结论 该法重复性好，简便可靠，为坤宁颗粒的质量控制和评价提供了依据。

Objective To establish the HPLC fingerprint for the quality control of Kunning Granules. Methods The Krmasil 100-5 C₁₈ column (250 mm×4.6 mm, 5 μm) was used with a mobile phase of acetonitrile-0.1% phosphoric acid for gradient elution. The flow rate was 1.0 mL/min, the column temperature was 30℃, and the detection wavelength was set at 280nm during 0-12 min and 230 nm during 12-55 min. The common peaks of fingerprints were identified, the similarity was analyzed, and the correlation between herbs and preparations was investigated. Results Fringerprints of 10 batches of Kunning Granules were analyzed, naringin was selected as reference, and 14 common peaks were marked and attributed to the herbs. The similarity degrees of 10 batches of the samples were above 0.95. Conclusion The method is reproducible, simple and reliable that it can be used for the quality control and evaluation of Kunning Granules.

R927.2

安徽省科技重大专项（18030801127）