摘要
目的:建立消炎灵胶囊的高效液相色谱(high performance liquid chromatography,HPLC)特征图谱法,通过相似度评价及聚类分析研究,为消炎灵胶囊的质量评价提供新思路。方法:使用HPLC,选择Waters Xselect C_(18)色谱柱,以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,流速1.0 mL/min,柱温30℃,检测波长280 nm。以甘草苷峰作为S峰,将32批消炎灵胶囊特征图谱文件导入《中药色谱指纹图谱相似度评价系统》(2012.1版),进行相似度计算,通过SPSS 26.0软件对结果进行聚类分析。结果:32批消炎灵胶囊HPLC特征图谱有14个共有特征峰,除5批样品外,其余样品相似度均大于0.900,相似度结果与聚类分析结果基本一致。结论:该研究方法及分析结果可为消炎灵胶囊的鉴别与质量控制提供新思路。
Objective:To establish a high performance liquid chromatography method for the characterization of Xiaoyanling capsules,and to provide a new idea for the quality evaluation of Xiaoyanling capsules through similarity evaluation and cluster analysis.Methods:A Waters Xselect C_(18) column was selected for HPLC,Gradient elution was performed with acetonitrile-0.1%phosphoric acid solution as mobile phase,the flow rate was set to 1.0mL/min,the column temperature was 30℃,and the detection wavelength was selected at 280 nm.Using the glycyrrhizin peak as the S-peak,32 batches of Xiaoyanling capsule characteristic atlas files were imported into the“TCM Chromatographic Fingerprint Similarity Evaluation System”(2012.1 edition)for similarity calculation.SPSS 26.0 software was used for cluster analysis of the results.Results:There were 14 common characteristic peaks in the HPLC chromatogram of 32 batches of Xiaoyanling capsules.Except for 5 batches of samples,the similarity of the other samples was greater than 0.900.The similarity results were basically consistent with the results of cluster analysis.Conclusion:The research method and analysis results can provide a new idea for the identification and quality control of Xiaoyanling capsules.
作者
张臻锴
郭璐玫
陈凤
刘兴鹏
Zhang Zhenkai;Guo Lumei;Chen Feng;Liu Xingpeng(Guizhou Institute for Food and Drug Control,Guiyang 550004,China)
出处
《广东化工》
CAS
2024年第14期151-154,共4页
Guangdong Chemical Industry
基金
国家药品抽检项目:国药监药管(2020)。
关键词
消炎灵胶囊
高效液相色谱法
特征图谱
相似度
聚类分析
xiaoyanling capsules
high performance liquid chromatography
specific chromatogram
similarity
cluster analysis
