目的 建立坤寧顆粒HPLC指紋圖譜，為其質(zhì)量控制提供依據(jù)。方法 采用Kromasil 100-5 C₁₈色譜柱（250 mm×4.6 mm，5 μm）；流動(dòng)相為乙腈-0.1%磷酸溶液，梯度洗脫；體積流量：1.0 mL/min；檢測(cè)波長(zhǎng)0~12 min為280 nm，12~55 min為230 nm；柱溫：30℃；進(jìn)樣量：10 μL。對(duì)指紋圖譜共有峰進(jìn)行指認(rèn)，分析相似度，并考察了藥材與制劑的相關(guān)性。結(jié)果 測(cè)定了10批坤寧顆粒，選擇柚皮苷作為參照物，提取14個(gè)色譜峰作為指紋圖譜共有峰，并將共有峰歸屬到各藥材；10批樣品相似度均大于0.95。結(jié)論 該法重復(fù)性好，簡(jiǎn)便可靠，為坤寧顆粒的質(zhì)量控制和評(píng)價(jià)提供了依據(jù)。

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

安徽省科技重大專項(xiàng)（18030801127）