摘要

In this paper, microemulsion electrokinetic chromatography (MEEKC) fingerprints combined with quantification were successfully developed to monitor the holistic quality consistency of Ixeris sonchifolia (Bge.) Hance Injection (ISHI). ISHI is a Chinese traditional patent medicine used for its anti-inflammatory and hemostatic effects. The effects of five crucial experimental variables on MEEKC were optimized by the central composite design. Under the optimized conditions, the MEEKC fingerprints of 28 ISHIs were developed. Quantitative determination of seven marker compounds was employed simultaneously, then 28 batches of samples from two manufacturers were clearly divided into two clusters by the principal component analysis. In fingerprint assessments, a systematic quantitative fingerprint method was established for the holistic quality consistency evaluation of ISHI from qualitative and quantitative perspectives, by which the qualities of 28 samples were well differentiated. In addition, the fingerprint-efficacy relationship between the fingerprints and the antioxidant activities was established utilizing orthogonal projection to latent structures, which provided important medicinal efficacy information for quality control. The present study offered a powerful and holistic approach to evaluating the quality consistency of herbal medicines and their preparations.