目的: 建立测定炎可宁片指纹图谱的方法,结合多元统计分析及多指标定量评价炎可宁片质量。方法: 采用InertSustain C18（250 mm×4.6 mm,5 μm）色谱柱,以甲醇-乙腈-0.2％磷酸溶液为流动相,梯度洗脱,体积流量1.0 mL · min-1,柱温30 ℃,检测波长254 nm,建立炎可宁片的HPLC指纹图谱,对17批炎可宁片中的10个成分（盐酸小檗碱、黄芩苷、汉黄芩苷、黄芩素、芦荟大黄素、汉黄芩素、大黄酸、大黄素、大黄酚、大黄素甲醚）进行含量测定,并结合相似度评价、聚类分析、熵权TOPSIS法、熵权-灰色关联度分析法对炎可宁片质量进行综合评价。结果: 目前市场上的炎可宁片质量差异较大,17批样品指纹图谱共匹配得到33个共有峰,相似度评价、聚类分析结果均显示不同样品之间存在差异,综合质量排名及多指标含量测定结果,揭示了影响药品质量重要因素是黄柏、黄连、黄芩3味药材的质量及工艺控制水平。结论: 本法建立的炎可宁片的指纹图谱结合多元统计模型,可为炎可宁片的质量评价研究及产品质量提高提供参考。
Objective: To establish a method for determining the fingerprint of Yankening tablets and evaluate their quality combined with multivariate statistical analysis and multi-component quantification. Methods: The seperation was performed on a 30 ℃ thermostatic InertSustain C18(250 mm×4.6 mm, 5 μm) column,with the mobile phase comprising of methanol-acetonitrile-0.2% phosphoric acid flowing at 1.0 mL · min-1 in a gradient elution manner, and the detection wavelength was set at 254 nm to establish HPLC fingerprint of Yankening tablets, contents of 10 components (berberine hydrochloride, baicalin, wogonoside, baicalein, aloe emodin, wogonin, rhein, emodin, chrysophanol, emodin methyl ether) in 17 batches of Yankening tablets were determined, and similarity evaluation, cluster analysis, entropy weight TOPSIS method, and entropy weight grey correlation analysis were used to comprehensively evaluate the quality of Yankening tablets. Results: There were significant differences in the quality of Yankening tablets of the current market. 33 common peaks were obtained by matching in the fingerprints of 17 batches of samples, and the similarity evaluation and cluster analysis results showed differences among different samples. The comprehensive quality ranking and multi-component content determination revealed that the important factors affecting drug quality were the quality and process control level of the three medicinal herbs, Phellodendri Chinensis Cortex, Coptidis Rhizoma and Scutellariae Radix. Conclusion: The fingerprint established by this method, combined with a multivariate statistical model, can provide reference for the quality evaluation research and products quality improvement of Yankening tablets.
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