目的 通过建立前列癃闭通片（Qianlielong Bitong Tablets，QBT）的UPLC指纹图谱，考察了9个厂家58批次QBT的质量，为完善该制剂的质量控制奠定基础。方法 采用UPLC法，色谱柱Eclipse Plus C₁₈ RRHD（50 mm×2.1 mm，1.8μm）；流动相为乙腈-0.1%甲酸水溶液，梯度洗脱，采用全时段多波长融合技术，体积流量0.3 mL/min；柱温30℃。建立QBT的指纹图谱，并对各样品的指纹图谱进行相似度评价，结合聚类分析评价58批样品的质量，指认了指纹图谱中主要共有峰的化学成分并确定了其药材归属。结果 首次建立QBT的UPLC指纹图谱，对其中16个共有峰进行了化学成分鉴定，分别是辛弗林（1号峰）、虎杖苷（2号峰）、金丝桃苷（3号峰）、新圣草苷（4号峰）、柚皮苷（5号峰）、橙皮苷（6号峰）、新橙皮苷（7号峰）、枸橘苷（8号峰）、朝藿定A（9号峰）、朝藿定B（10号峰）、朝藿定C（11号峰）、淫羊藿苷（12号峰）、芒柄花素（13号峰）、宝藿苷（14号峰）、大黄素（15号峰）、大黄素甲醚（16号峰），确定了16个特征峰来源于方中4味中药，峰1、4～8归属枳壳药材，峰2、3、15、16归属虎杖药材，峰9～12、14归属淫羊藿药材，峰13归属黄芪药材。对9个生产企业58批次样品进行相似度评价，相似度分布在0.600～0.912，通过聚类分析大致可聚为4类。结论 建立QBT的指纹图谱，该方法简便、可靠，为进一步评价和监测QBT的质量提供参考。

Objective To establish an UPLC fingerprint of Qianlielong Bitong Tablets (前列癃闭通片, QBT) for quality evaluation of 58 batches of QBT from nine different manufacturers, so as to support the foundation of quality control system of the tablets. Methods The method was performed by UPLC with Eclipse Plus C₁₈ RRHD (50 mm×2.1 mm, 1.8 μm) column; acetonitrile-0.1% formic acid aqueous as the mobile phase for gradient elution, with the all-time multi-wavelength fusion. The flow rate was 0.3 mL/min, column temperature was 30℃. The HPLC fingerprint was established and evaluated by the similarity evaluation system of QBT, the quality of 58 batches of samples was evaluated by cluster analysis. The chemical constituents of the main common peaks were identified in the fingerprint and attributed to raw materials. Results The UPLC fingerprint of QBT was developed firstly, the chemical constituents of 16 common peaks were identified, including synephrine (peak 1), polydatin (peak 2), hyperoside (peak 3), neoeriocitrin (peak 4), naringin (peak 5), hesperidin (peak 6), neohesperidin (peak 7), poncirin (peak 8), epimedin A (peak 9), epimedin B (peak 10), epimedin C (peak 11), icariin (peak 12), formononetin (peak 13), baohuoside (peak 14), emodin (peak 15), physcion (peak 16), and the 16 characteristic peaks were determined from four traditional Chinese medicines. The peaks 1, 4-8 were attributed to Zhiqiao (Aurantii Fructus), the peaks 2, 3, 15, 16 Astragali Radix to Huzhang (Polygoni Cuspidati Rhizoma et Radix), the peaks 9-12, 14 Astragali Radix to Yinyanghuo (Epimedii Folium), the peak 13 Astragali Radix to Huangqi (Astragali Radix). The analyzed samples were geographically classified into four classes with the similarities between 0.600-0.912. Conclusion The fingerprint of QBT was developed, the method is simple and reliable. It provides reference for further evaluation and monitoring the quality of QBT.

R286.02