清热解毒颗粒的HPLC指纹图谱建立及聚类分析

    Establishment of HPLC Fingerprint of Qingre Jiedu Granules and Cluster Analysis

    • 摘要: 目的 建立清热解毒颗粒的HPLC指纹图谱,并进行聚类分析。方法 色谱柱为Phenomenex C18(250 mm×4.6 mm,5 μm),以甲醇-0.1%磷酸溶液为流动相梯度洗脱,流速为1.0 mL·min-1,柱温为30℃,检测波长为325 nm。采用“中药色谱指纹图谱相似度评价系统”(2012版)进行相似度评价,采用SPSS 21.0软件对15批样品进行聚类分析。结果 建立了清热解毒颗粒的HPLC指纹图谱,确定了22个共有峰,指认了4个峰,相似度均≥0.916。15批样品可聚为3大类,S1~S7聚为Ⅰ类、S8~S10聚为Ⅱ类,S11~S15聚为Ⅲ类。结论 采用HPLC建立的指纹图谱方法简单,重复性好,可用于清热解毒颗粒的质量控制和工艺评价。

       

      Abstract: OBJECTIVE To establish the HPLC fingerprint chromatogram of Qingre Jiedu granules, and to conduct cluster analysis. METHODS HPLC was performed on Phenomenex C18 column(250 mm×4.6 mm, 5 μm) with the mobile phase consisted of methanol-0.1% phosphoric acid solution in gradient mode. The flow rate was 1.0 mL·min-1 under the temperature of 30℃, with a detection wavelength of 325 nm. The similarity evaluation was carried out by Similarity Evaluation System for TCM Chromatographic Fingerprint (2012 Edition). Cluster analysis was carried out by using SPSS 21.0 statistical software. RESULTS The HPLC fingerprint of Qingre Jiedu granules with 22 commons peaks, and four of them were identified by comparing with reference substances. The similarity was ≥ 0.916. Fifteen batches of samples were divided into 3 categories. S1-S7 could be grouped into category Ⅰ; S8-S10 could be grouped into category Ⅱ; S11-S15 could be grouped into category Ⅲ. CONCLUSION The established method is simple and reproducible. The fingerprint and cluster analysis results can be used for the quality control and process evaluation.

       

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