目的建立华盖散制剂的HPLC指纹图谱,指认其特征峰,并进行制剂-药材谱峰匹配研究。方法对12个批次的样品进行HPLC指纹图谱相似性评价并与原药材进行谱峰匹配,采用HPLC-二极管阵列检测法,检测波长280 nm,流动相为乙腈-0.2%磷酸水溶液,线性梯度洗脱,体积流量0.6 m L/min,柱温30℃,并采用SPSS 19.0统计软件进行聚类分析。结果12批样品色谱图中有26个共有峰,其中第4、5、10、17、18、20、21号共有峰分别为盐酸麻黄碱、盐酸伪麻黄碱、绿原酸、甘草苷、甘草酸、柚皮芸香苷和橙皮苷,麻黄、桑白皮、陈皮、苦杏仁、甘草、紫苏子分别有6、3、6、1、4、1个色谱峰与复方谱共有峰匹配。各批样品指纹图谱相似度均大于0.960,聚类分析表明可将华盖散样品聚为3类。结论建立的华盖散指纹图谱相似度评价结合制剂用药材与制剂指纹图谱谱峰匹配相结合的方法为其鉴别与质量控制提供了科学的评价方法。 OBJECTIVE To establish HPLC fingerprint of Huagai Powder and identify its characteristic peaks, and to study the peak-match of preparation-medicinal materials. Methods The similarity of HPLC fingerprints of 12 batches of samples was evaluated and their peaks were matched with those of the original medicinal materials. The HPLC-diode array was used to detect the wavelength of 280 nm. The mobile phase consisted of acetonitrile-0.2% phosphoric acid solution and linear gradient Off, volume flow 0.6 m L / min, column temperature 30 ℃, and using SPSS 19.0 statistical software for cluster analysis. Results There were 26 common peaks in 12 batches of chromatograms, of which the common peaks of No. 4,5,10,17,18,20,21 were ephedrine hydrochloride, pseudoephedrine hydrochloride, chlorogenic acid, glycyrrhizin, glycyrrhizin, Pomelo rutin and hesperidin, ephedra, Morus alba, dried tangerine peel, bitter almonds, licorice, perilla were 6,3,6,1,4,1 peak and compound spectrum shared peak matching. Similarity of fingerprints in each batch of samples was greater than 0.960, and cluster analysis showed that the samples of Huagai powder could be grouped into three categories. Conclusions The similarity evaluation of Huayai-San fingerprinting fingerprint combined with the method of peak-matching of preparation medicinal materials and preparation fingerprinting spectrum provides a scientific evaluation method for its identification and quality control.