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 mL/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 fingerprints of Huagai San and identificate the characteristic peaks ion and preparations- medicinal materials peak pattern matching. Methods Similarity on 12 batches of Huagai San was estimated, and peak pattern matching of the original medicine was conducted. Sample extraction with methanol in ultrasonic condition was carried out. HPLC- DAD methods were developed, detection wave length was set at 280 nm, HPLC mobile phase consisted of acetonitrile-0.2% phosphate acid aqueous solution, volume flow-rate was delivered at 0.6 mL/min, and column temperature was kept at 30 ℃. Cluster analysis of 12 batches of Huagai San was analyzed by SPSS 19.0. Results The results showed that 26 common peaks were defined, the peaks No. 4, 5, 10, 17, 18, 20, and 21 were ephedrine hydrochloride, pseudoephedrine hydrochloride, chlorogenic acid, liquiritin, glycyrrhizic acid, narirutin, and hesperidin, respectively, and peak pattern matching showed that Huagai San had 6, 3, 6, 1, 4, and 1 matching peaks with Ephedrae Herba, Mori Cortex, Citri Reticulatae Pericarpium, Armeniacae Semen Amarum, Glycyrrhizae Radix et Rhizoma, and Perillae Fructus, respectively. The fingerprint similarity among the samples was all over 0.960. All the samples were classified into three categories. Conclusion Similarity evaluation combined with the peak matching of fingerprint for Huagai San could provide the scientific methods for its identification and quality control.

国家科技重大专项课题——经典名方标准颗粒的研究(2013ZX09508-105)