Research On Evaluation Methods Of E-jiao Slurry Extracting Process And Lonicerae Japonicae Flos Extraction Quality Based On TCM Finoerprint

Traditional Chinese medicine quality evaluation focused on content determination of active composition, which cannot reflect the characteristics of complex chemical composition of traditional Chinese medicine. In recent years, TCM fingerprint, which can reveal and control the comprehensive quality of TCM, has been used for the measurement of TCM raw materials, in-process materials and final products. In this work, multivariate data analysis was combined with high performance liquid chromatography-mass spectrometry (HPLC-MS) fingerprint and proton nuclear magnetic resonance (~1H-NMR) spectroscopy to explore the consistency evaluation methods of Lonicerae Japonicae Flos extract quality and E-jiao Slurry extracting process based on traditional Chinese medicine fingerprint. The main contents of this dissertation are summarized as follows:1. The batch-to-batch consistency evaluation method of E-jiao Slurry extracting process based on HPLC-MS fingerprint was established. First we constructed the HPLC-MS chemical fingerprint of E-jiao Slurry, after optimizing the MS conditions. The results of methodological evaluation showed that the established fingerprint was stable and reliable as quality control method. The common peaks in the fingerprint were assigned and identified, which fully characterized the major components from four raw herbal materials. Multivariate statistical analysis was applied on the HPLC-MS fingerprint data of finished products. The possible causes responsible for quality abnormality were analyzed according to the variations of characteristic peak areas. This approach can help to diagnose the abnormal variations of herbal materials and operating parameters in time, and can provide guidance on adjustments of subsequent batches.2. The method for fast quality evaluation of Lonicerae Japonicae Flos extract based on ~1H-NMR was presented. We studied and optimized the NMR conditions and sample pretreatment method. The results of methodological evaluation showed that the established fingerprint was stable and reliable as quality control method. The ~1H-NMR spectra of samples extracted in different years were collected, and quality consistency evaluation was achieved using multivariate statistical analysis. This study provides a fast statistical evaluation method for large amounts of herbal products during TCM industrial production.