基于指纹图谱及聚类分析的蒲地蓝消炎片质量评价

Quality Evaluation of Pudilan Xiaoyan Tablets Based on Fingerprint and Cluster Analysis

目的采用HPLC建立蒲地蓝消炎片指纹图谱,并结合聚类分析对不同产地的蒲地蓝消炎片进行质量评价。方法基于波长切换技术,采用Agilent Poroshell 120 SB-C18色谱柱(2.1 mm×50 mm,2.7μm),以甲醇、乙腈和0.1%磷酸溶液为流动相,梯度洗脱,流速为0.3 mL·min^-1;柱温为30℃,检测波长为323 nm(0~10 min)和280 nm(10~40 min)。运用“中药色谱指纹图谱相似度评价系统”软件(2012.130723版),对12家企业生产的45批样品进行相似度评价,并应用SPSS 24.0统计软件进行系统聚类分析。结果建立的指纹图谱共确定14个共有峰,并对其中7个共有峰进行鉴定。45批样品的相似度为0.901~0.999,表明该制剂总体质量较为稳定。聚类分析结果表明,样品可分为4类,分类受生产工艺、药材质量的影响较大。结论通过相似度评价和聚类分析发现个别企业存在低质饮片投料、少投料、工艺过程控制不当以及疑似添加黄芩苷的情况。建立的指纹图谱方法科学、可靠,能为蒲地蓝消炎片中活性成分的鉴定和分析提供准确的信息,为综合评价和控制相关制剂质量提供依据。

OBJECTIVE To establish fingerprints of Pudilan Xiaoyan tablets by HPLC,and the quality of Pudilan Xiaoyan tablets from different producing areas was evaluated by cluster analysis.METHODS Based on wavelength switching technology,Agilent Poroshell 120 SB-C18 column(2.1 mm×50 mm,2.7μm)was used,the mobile phase was methanol,acetonitrile and 0.1%phosphoric acid with gradient elution,flow rate was 0.3 mL·min^-1.The temperature was 30℃,and the detection wavelength was 323 nm(0-10 min)and 280 nm(10-40 min).Used the“Chinese medicine chromatographic fingerprint similarity evaluation system”software(2012.130723 version),45 batches of samples produced by 12 enterprise were evaluated for similarity,and SPSS 24.0 statistical software was used for system cluster analysis.RESULTS The established fingerprints defined 14 common peaks and identified 7 common peaks.The similarity of the 45 batch samples was 0.901-0.999,indicating that the overall quality of the preparation was relatively stable.The results of cluster analysis showed that the samples could be divided into four categories,and the classification was greatly influenced by the production process and the quality of the medicinal materials.CONCLUSION Through the similarity evaluation and cluster analysis results,it is found that individual enterprises have low-quality decoction pieces,less feeding,improper control in the process,and suspected addition of baicalin.The method of fingerprint is scientific and reliable,and can provide accurate information for the identification and analysis of active ingredients in Pudilan Xiaoyan tablets.This study provides the basis of comprehensive evaluation and quality control of related preparations.