中药新药与临床药理2026，Vol.37Issue(1)：169-178,10.DOI:10.19378/j.issn.1003-9783.2026.01.017
基于指纹图谱及多指标成分定量结合化学计量法的跌打祛风膏质量评价
Quality Evaluation of Dieda Qufeng Plaster Based on HPLC Fingerprint Profiling,Multi-Index Component Quantification and Chemometrics
摘要
Abstract
Objective To establish a high-performance liquid chromatography(HPLC)fingerprint for Dieda Qufeng Plaster,simultaneously determine the contents of eight characteristic components,and comprehensively evaluate its quality by combining chemometric methods.Methods An HPLC fingerprint method for 10 batches of Dieda Qufeng Plaster was developed using a Shimadzu Shim-pack GIST C18-AQ column(4.6 mm×250 mm,5 μm).The mobile phase consisted of acetonitrile and-0.05%phosphoric acid aqueous solution with gradient elution.The detection wavelength was set at 206 nm,the column temperature at 30℃,the injection volume at 10 μL,and the flow rate at 1.0 mL·min-1.Simultaneously,the contents of eight components-vanillin,ferulic acid,naringin,benzoic acid,notopterol,osthole,emodin,and isoimperatorin were determined.The quality of the 10 batches was comprehensively evaluated using hierarchical cluster analysis(HCA),principal component analysis(PCA),and orthogonal partial least squares-discriminant analysis(OPLS-DA).Results The HPLC fingerprints of the 10 batches identified 29 common peaks,with similarity values all exceeding 0.950.The content ranges for the eight components were as follows:vanillin 26.071 4-77.457 8 μg·g-1,ferulic acid 2.657 7-12.982 0 μg·g-1,naringin 5.368 5-19.502 4 μg·g-1,benzoic acid 101.082 7-453.386 0 μg·g-1,notopterol 15.024 0-57.219 1 μg·g-1,osthole 2.228 9-22.676 8 μg·g-1,emodin 28.187 1-41.741 4 μg·g-1,and isoimperatorin 18.775 8-51.405 7 μg·g-1.HCA results showed that the 10 batches could be classified into four categories:S1,S2-S4,S5-S7,and S8-S10.PCA yielded five principal components with a cumulative variance contribution rate of 94.314%.OPLS-DA identified eight components[peak 5,peak 9,peak 13,peak 14(benzoic acid),peak 19,peak 22,peak 26(isoimperatorin),and peak 29]as differential quality markers affecting the quality of Dieda Qufeng Plaster.Conclusion The established HPLC fingerprint method combined with multi-index component quantification is stable and reliable,providing a scientific basis for the quality control of Dieda Qufeng Plaster.关键词
跌打祛风膏/指纹图谱/含量测定/化学计量法/差异质量标志物Key words
Dieda Qufeng Plaster/fingerprint/content determination/chemometrics/differential quality markers分类
医药卫生引用本文复制引用
莫静媛,黄小玲,谢询,黄晓晴,苏安宇,黄晓冰,黄雨威,王利胜..基于指纹图谱及多指标成分定量结合化学计量法的跌打祛风膏质量评价[J].中药新药与临床药理,2026,37(1):169-178,10.基金项目
湖北省武汉市医学科研项目(WZ19C29) （WZ19C29）
广州市科技计划项目(2022060188) （2022060188）
广东省基础与应用基础研究项目(2022A1515220078). （2022A1515220078）
