The composition of traditional Chinese medicine is extremely complex, so it is difficult to ensure quality consistency. We took Compound Danshen Tablets as the object of the study, by using high-performance liquid chromatography to establish multiwavelength fusion fingerprints. Characteristic fingerprints of 30 batches of samples were generated at four wavelengths and evaluated by systematic quantified fingerprint method. An on-line antioxidant determination method was used for the determination of the antioxidant components in Compound Danshen Tablets. The fingerprint analysis of the marker compounds can reflect the content of the marker compounds, which were determined by using the external standard method. This study elucidated that multiwavelength fusion fingerprint profiles and multiple markers compound analysis in conjunction with the assay of antioxidant activity offered a reliable and efficient approach to quantitatively evaluate the quality consistency of the traditional Chinese medicine and herbal preparations.
A combination method of multi-wavelength fingerprinting and multi-component quantification by high performance liquid chromatography (HPLC) coupled with diode array detector (DAD) was developed and validated to monitor and evaluate the quality consistency of herbal medicines (HM) in the classical preparation Compound Bismuth Aluminate tablets (CBAT). The validation results demonstrated that our method met the requirements of fingerprint analysis and quantification analysis with suitable linearity, precision, accuracy, limits of detection (LOD) and limits of quantification (LOQ). In the fingerprint assessments, rather than using conventional qualitative “Similarity” as a criterion, the simple quantified ratio fingerprint method (SQRFM) was recommended, which has an important quantified fingerprint advantage over the “Similarity” approach. SQRFM qualitatively and quantitatively offers the scientific criteria for traditional Chinese medicines (TCM)/HM quality pyramid and warning gate in terms of three parameters. In order to combine the comprehensive characterization of multi-wavelength fingerprints, an integrated fingerprint assessment strategy based on information entropy was set up involving a super-information characteristic digitized parameter of fingerprints, which reveals the total entropy value and absolute information amount about the fingerprints and, thus, offers an excellent method for fingerprint integration. The correlation results between quantified fingerprints and quantitative determination of 5 marker compounds, including glycyrrhizic acid (GLY), liquiritin (LQ), isoliquiritigenin (ILG), isoliquiritin (ILQ) and isoliquiritin apioside (ILA), indicated that multi-component quantification could be replaced by quantified fingerprints. The Fenton reaction was employed to determine the antioxidant activities of CBAT samples in vitro, and they were correlated with HPLC fingerprint components using the partial least squares regression (PLSR) method. In summary, the method of multi-wavelength fingerprints combined with antioxidant activities has been proved to be a feasible and scientific procedure for monitoring and evaluating the quality consistency of CBAT.
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