关键词: 肤痒颗粒, 高效液相色谱, 指纹图谱, 聚类分析, 质量控制

Abstract:

Objective： To establish the HPLC fingerprint of fuyang granule.Methods： A C₁₈ column was used for separation， with a column temperature at 35 ℃，a flow rate of 1.0 mL·min^-1.The detection wavelength was set at 327 nm.The mobile phase consisted of methanol-0.4% phosphoric acid solution by gradient elution. The injection volume was 10 μL.The similarity evaluation of 19 batches of fuyang granule was carried out by using Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）.Results： 9 common peaks were found in HPLC fingerprints， 4 of them were neochlorogenic acid， chlorogenic acid， cryptochlorogenic acid and ferulic acid. Compared with the control fingerprint，the similarity of 19 batches of fuyang granule was 0.767-0.995， the relative retention time range was 0.189-1.587， and the relative peak area ratio was 0.032-11.220. The 19 batches of samples can be clustered into 3 categories. By Comparing with the characteristic fingerprint，it shows the similarities of 2 batches of Company A and 1 batch of Company B were below 0.9， while the similarities of Company E， G， and L （one batch） were all higher than 0.98.Conclusion： The established HPLC method showed good stability and repeatability. It can be used as a quality evaluation method for fuyang granule，and provides a reference for the quality control.

Key words:  , Fuyang granule； , High performance liquid chromatography； , Fingerprints； , Cluster analysis； , Quality control