Abstract
A widely used herbal medicine, Ixeris sonchifolia (Bge.) Hance Injectable (ISHI) was investigated for quality consistency. Characteristic fingerprints of 23 batches of the ISHI samples were generated at five wavelengths and evaluated by the systematic quantitative fingerprint method (SQFM) as well as simultaneous analysis of the content of seven marker compounds. Chemometric methods, i.e., support vector machine (SVM) and principal component analysis (PCA) were performed to assist in fingerprint evaluation of the ISHI samples. Qualitative classification of the ISHI samples by SVM was consistent with PCA, and in agreement with the quantitative evaluation by SQFM. In addition, the antioxidant activities of the ISHI samples were determined by both the off-line and on-line DPPH (2, 2-diphenyl-1-picryldrazyl) radical scavenging assays. A fingerprint–efficacy relationship linking the chemical components and in vitro antioxidant activity was established and validated using the partial least squares (PLS) and orthogonal projection to latent structures (OPLS) models; and the online DPPH assay further revealed those components that had position contribution to the total antioxidant activity. Therefore, the combined use of the chemometric methods, quantitative fingerprint evaluation by SQFM, and multiple marker compound analysis in conjunction with the assay of antioxidant activity provides a powerful and holistic approach to evaluate quality consistency of herbal medicines and their preparations.
Highlights
Traditional Chinese Medicine (TCM) and herbal preparations have been widely used by billions of people around the world for thousands of years
In order to achieve reproducible separation and acceptable resolution in a short analysis time, we investigated four mobile phase (MP: MP1~MP4) conditions and three gradient elution programs (GEP: GEP1~GEP3)
From S1 File, it was found that the I values for the four mobile phase conditions MP1~MP4 are 15.7, 14.9, 15.9 and 15.5, respectively; while the I values for the three gradient programs GEP1~GEP3 are 13.6, 16.4 and 16.7, respectively
Summary
Traditional Chinese Medicine (TCM) and herbal preparations have been widely used by billions of people around the world for thousands of years. Holistic Evaluation of Quality Consistency of ISHI and Drug Administration (FDA) and European Medicine Agency (EMA) have all accepted the chromatography fingerprinting method and promote its use for the quality control of herbal preparations [2,3,4,5]. Unsupervised pattern recognition methods, such as PCA as well as supervised methods, such as SVM, PLS, partial least squares discriminant analysis (PLS-DA), OPLS, and orthogonal projection to latent structures discriminate analyses (OPLS-DA), have been increasingly applied to chromatography fingerprinting analysis in support of the quality control of TCM and herbal preparations [14,15,16,17]. Jian Liang et al adopted PCA and OPLS methods to evaluate the quality consistency of complex TCM preparations [11]
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