中国药业2025，Vol.34Issue(10)：95-99,5.DOI:10.3969/j.issn.1006-4931.2025.10.020
超高效液相色谱指纹图谱结合化学模式评价苁蓉通便口服液质量
Quality Evaluation of Congrong Tongbian Oral Liquid by Ultra-High Performance Liquid Chromatography Fingerprint Combined with Chemical Pattern Recognition
摘要
Abstract
Objective To establish an ultra-performance liquid chromatography(UPLC)fingerprint for Congrong Tongbian Oral Liquid and evaluate the quality of the preparation.Methods The chromatography column was the Waters BEH-C18 column(150 mm×2.1 mm,1.7 µm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(gradient elution),the flow rate was 0.4 mL/min,the detection wavelength was 230 nm,the column temperature was 35℃.Chempattern software was used to establish the HPLC fingerprint,the common peaks were marked,and similarity evaluation was performed.Quality evaluation of 14 batches of samples was conducted by integrating cluster analysis(CA)and principal component analysis(PCA).Results A total of 10 common peaks were marked in the UPLC fingerprint of 14 batches of samples,and eightcommon components were identified.The similarity of 14 batches of samples was all higher than 0.9;the CA showed that the samples could be clustered into two categories,the resultts of PCA showed that the weight coefficients of emodin,stilbene glycoside,narirutin,and hesperidin were higher among the 8 components.Conclusion The production process of 14 batches of Congrong Tongbian Oral Liquid shows good consistency.The established UPLC fingerprint combined with chemical pattern recognition provides an effective method for comprehensive quality control of the preparation.关键词
苁蓉通便口服液/超高效液相色谱法/指纹图谱/聚类分析/主成分分析/质量评价Key words
Congrong Tongbian Oral Liquid/UPLC fingerprint/cluster analysis/principal component analysis/quality evaluation分类
医药卫生引用本文复制引用
石晶,朱旭江,张迈娜,马庆博,于亚娟..超高效液相色谱指纹图谱结合化学模式评价苁蓉通便口服液质量[J].中国药业,2025,34(10):95-99,5.基金项目
国家药典委员会标准修订研究课题[2019Z010] （）
甘肃省药品监督管理局药品科研项目[2022GSMPA0026,2022GSM-PA0027,2023GSMPA059]. （）
