Objective To evaluate the quality of different batches of Cirsium Japonicum Formula Granules(CJFG)from different manufacturers.Methods High-performance liquid chromatography(HPLC)method was used for the content determination of five active ingredients in CJFG,the chromatographic column was Agilent Extend C18 column(250 mm × 4.6 mm,5 µm),the mobile phase was acetonitrile methanol(4∶1,V/V)-0.1%phosphoric acid solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 330 nm,the column temperature was 30 ℃,and the injection volume was 10 µL.The fingerprints of CJFG were established to identify common peaks through comparison,and evaluate similarity.Cluster analysis(CA),principal component analysis(PCA),and orthogonal partial least squares-discriminant analysis(OPLS-DA)were used to analyze 17 batches of samples from five manufacturers.Results The fingerprints of CJFG had fourteen common peaks,and eight peaks were identified.CA and PCA results divided 17 batches of CJFG into four categories.OPLS-DA identified six differential marker components,and the order of their significance was apigenin-7-O-glucuronide>peak 7>chlorogenic acid>peak 9>cryptochlorogenic acid>pecaalinarin.The five components had a good linear relationship with peak area within their respective mass concentration ranges(r ≥ 0.999 1,n=5).The average recovery rate was in the range of 95.88%-99.12%,with RSD of 1.40%-2.00%(n=9).Conclusion The method is simple,and the results of methodological investigation are good,which can be used for the quality evaluation of CJFG.
关键词
大蓟配方颗粒/高效液相色谱指纹图谱/多成分定量/聚类分析法/主成分分析法/正交偏最小二乘判别分析法
Key words
Cirsium Japonicum Formula Granules/HPLC fingerprints/multi-compontnt determination/cluster analysis/principal component analysis/orthogonal partial least squares-discriminant analysis