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目的:建立二母颗粒的HPLC-ELSD特征指纹图谱。方法:采用HPLC-ELSD,选用Global Chromatography C18色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-水梯度洗脱,流速1.0 mL.min-1,漂移管温度45℃,增益值1,雾化空气流速1.5 L.min-1。对10批二母颗粒样品进行HPLC-ELSD测定,并与知母药材、知母浸膏的HPLC-ELSD图谱进行对比,采用“中药色谱指纹图谱相似度评价系统”2004年版A进行相似度评价。结果:10批二母颗粒样品与知母药材、知母稠膏的相似度较高(0.960～0.998)。结论:二母颗粒的HPLC-ELSD指纹图谱能更加完善二母颗粒的质量评价体系,为其他制剂品种的“原药材-中间体-成品”的全过程控制研究提供参考。
Objective: To establish HPLC-ELSD characteristic fingerprint of Ermu granule. Methods: The chromatographic column (4.6 mm × 250 mm, 5 μm) was used as the chromatographic column. The mobile phase was eluted with acetonitrile-water gradient at a flow rate of 1.0 mL · min-1. The temperature of the drift tube was 45 ℃, Atomized air flow rate 1.5 L.min-1. HPLC-ELSD was performed on 10 batches of Ermu granule samples and compared with the HPLC-ELSD patterns of Zhimu herbs and Zhimu extract. The similarities were evaluated using the “Chinese Medicines Chromatographic Fingerprinting Similarity Evaluation System” 2004 Edition A Evaluation. Results: The similarity between 10 batches of Ermu granule samples and Zhimu medicinal materials and Anemarrhena asphodeloides was higher (0.960 ~ 0.998). Conclusion: HPLC-ELSD fingerprinting of Ermu granule can further improve the quality evaluation system of Ermu granule and provide references for the whole process control study of other crude drug products.