目的 建立银黄清肺胶囊的HPLC指纹图谱,为评价其质量提供依据。方法 采用Inertsil ODS-2 C₁₈(250 mm×4.6 mm,5 μm)色谱柱;检测波长210 nm;以乙腈-水(含0.1%磷酸)为流动相进行梯度洗脱;体积流量1.0 mL/min;柱温30 ℃;进样量10 μL。测定10批银黄清肺胶囊的色谱图,应用相似度分析软件建立银黄清肺胶囊共有模式,并对色谱峰进行指认。结果 建立了银黄清肺胶囊HPLC指纹图谱,在确定的方法下,得到10批银黄清肺胶囊的色谱图,并获得了10批样品的相似度;确定共有峰28个,其中26个归属到各药材,确定14个已知成分。通过聚类分析,10批银黄清肺胶囊可以分为2类。结论 建立的HPLC指纹图谱方法操作简便,准确稳定,重复性好,为银黄清肺胶囊的质量控制提供了有效的手段。

Objective To establish HPLC fingerprint for Yinhuang Qingfei Capsule. Methods The HPLC method was used with the condition that the column was Inertsil ODS-2 C₁₈ (250 mm × 4.6 mm, 5 μm); The detection wavelength was set at 210 nm; The mobile phase was eluted with gradient by mixture of acetonitrile and water (0.1% phosphoric acid); The flow rate was 1.0 mL/min; The column temperature was 30 ℃; The injection was 10 μL. The common mode of HPLC fingerprint for ten batches of Yinhuang Qingfei Capsule was established with similarity analyses and the peaks were identified. Results Under the selected spectrum condition, the HPLC fingerprint for ten batches of Yinhuang Qingfei Capsule and the similarities for ten batches of samples were obtained. Twenty-eight peaks were found, 26 belong to herbs and 14 were assigned. The ten samples were classified into two clusters by cluster analysis. Conclusion The method can be used for the quality control of Yinhuang Qingfei Capsule with good precision, accuracy, and reproducibility.

湖南省科技厅科技计划专项(2014XK4008);湖南省战略新兴产业项目科技攻关类项目(2014GK1022);长沙市生物与新医药产业科技支撑重大专项项目:中药创新关键技术研究及产业化(K1204035-31)