基于HPLC指纹图谱抗感颗粒质量评价研究

目的：建立抗感颗粒高效液相色谱指纹图谱测定方法。方法采用 Kromasil 100-5C18色谱柱，以乙腈-0.4％磷酸溶液为流动相梯度洗脱，波长切换模式进行检测（检测波长为327 nm 和230 nm），建立抗感颗粒的对照指纹图谱，并对66批抗感颗粒进行质量评价。结果通过《中药色谱指纹图谱相似度评价系统》2004年版进行评价，66批抗感颗粒中18批相似度结果偏低，不足0.90。金银花多个指标成分含量偏低是相似度测定结果偏低的主要原因。结论建立的高效液相色谱指纹图谱具有良好的精密度、重复性和稳定性，适用于抗感颗粒批间均一性的质量评价。

Quality control of Kanggan Granules by HPLC fingerprint

Objective To develop an HPLC fingerprint method for the quality control of Kanggan Granules.Methods Kromasil 100-5C18 column was adopted with the gradient elution solvent composed of acetonitrile and 0.4% phosphoric acid solution.Wavelength switching technology was applied with the detection wavelength at 327 nm and 230 nm.66 batches of samples were evaluated based on the referential fingerprint.Results By the Similarity Evaluation System for Chromato-graphic Fingerprint of Traditional Chinese Medicine(Vision 2004),the similarity of chromatogram for each batch was evalu-ated.The calculated similarity value of 18 batches were under 0.90,with the main reason of low levels of multiple compo-nents from Lonicerae Japonicae Flos. Conclusion With the satisfactory precision,reproducibility and stability,the established HPLC fingerprint can be perfectly applied in the quality evaluation of Kanggan Granules.