中国药业2025，Vol.34Issue(8)：68-73,6.DOI:10.3969/j.issn.1006-4931.2025.08.016
缓哮膏指纹图谱建立及多成分含量测定
HPLC Fingerprint of Huanxiao Ointment and Determination of Multi-Components
摘要
Abstract
Objective To establish HPLC Fingerprint of Huanxiao Ointment and Determine the content of Multi-Components.Methods The chromatography column was the Agilent ZORBAX SB-C18 column(250 mm×4.6 mm,5 μm),the mobile phase was Acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the detection wavelength was 280 nm the flow rate was 1.0 mL/min,the column temperature was 25℃,and the injection volume was 10 μ L.The HPLC fingerprints of 15 batches were generated using the TCM Similarity Evaluation System(2012),followed by similarity analysis,common peak marking,component identification,and content determination.Results A total of 52 common peaks were calibrated,and the similarity of all 15 batches of samples exceeded 0.930.Seven components were identified,including calycosin-7-O-β-D-glucoside,prim-O-glucosylcimifugin,5-O-methylvisammioside,naringin,caffeic acid,chlorogenic acid,hesperidin,the linear ranges were 0.064 4 to 5.094 mg/mL,0.011 3 to 4.397 mg/mL,0.053 1 to 1.287 mg/mL,0.061 9 to 3.132 mg/mL,0.307 7 to 9.94 mg/mL,0.070 5 to 51.29 mg/mL,0.075 4 to 50.99 mg/mL respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%(n=6).The average recovery rates of the above seven components were 88.69%,92.53%,102.55%,88.16%,95.87%,91.22%,92.90,with RSDs of 1.65%,0.14%,1.18%,0.19%,1.50%,1.67%,1.51%(n=6),respectively.The average contents were 3.21 mg/g,1.23 mg/g,1.22 mg/g,1.67 mg/g,1.47 mg/g,3.54 mg/g,13.87 mg/g.Conclusion The established HPLC fingerprint method and multi-component quantification approach for Huanxiao Ointment are stable and reliable,and can be effectively applied for quality control of the preparation.关键词
缓哮膏/指纹图谱/高效液相色谱法/质量控制Key words
Huanxiao Ointment/fingerprint/HPLC/quality control分类
医药卫生引用本文复制引用
沈洁,张峻铭,吴文辉,杨敏..缓哮膏指纹图谱建立及多成分含量测定[J].中国药业,2025,34(8):68-73,6.基金项目
四川省科技厅区域创新合作项目[2023YFQ0010]. （）
