Study On Spectrum-Effect Relationship Of Enhancing Immunity Effects In Zhenqi Fuzheng Preparation

Zhenqi Fuzheng preparation(ZFP)is a most classical formula of traditional Chinese medicines(TCMs),comprising Radix Astragali(Huangqi in Chinese)and Fructus Ligustri Lucidi(Nvzhenzi in Chinese).It is commonly used in clinical practice for the treatment to improve immunity,promote the recovery of normal functions as an accessory of surgical operation,and it was the most important as an adjuvant therapy of cancer.Complementary therapies are increasingly used in the Western world,especially among cancer patients.A recent European survey has shown that herbal medicine used among cancer patients was the most common complementary therapy reported across Europe.Therefore,to ensure the clinical efficacy and safety,the overall quality control of ZFC is of significant importance.As is known to all,the quality control of TCMs is a complex system like a black box.The curative effect is contributed with many chemical components.Firstly,the attributive analysis and identification of its medicinal materials were performed by HPLC-DAD-ELSD.The sources of 19 chromatographic peaks and separately identified such ten index components as calycosin-7-O-?-D-glucoside,ononin and so on were found.Twenty-one batches of samples were used to create the fingerprints of the HPLC-DAD and HPLC-ELSD chromatograms,including 25 common peaks.Ten batches of samples were used to conduct pharmacodynamic experiments on the enhancing immunity effects in animals including phagocytic index,delayed type hypersensitivity(DTH)degree,organs index and the level of cytokines IFN-?,IL-4(ELISAs).The results of the pharmacodynamic effects were correlated using gray relation statistics with the peak areas of the compounds,and many components show a significant correlation with the enhancement of immunological function.The quantitative method of rhodioside,calycosin-7-O-?-D-glucoside and astragaloside IV in Zhenqi Fuzheng capsule was established by ultra-pressure liquid chromatography with tandem mass spectrometry(UPLC-ESI-MS)method and it is fast only 12 min.The experiment provides the experimental basis and technical support to the quality control of Zhenqi Fuzheng preparation from multi-angle,multi-dimensional manner.The research can evaluate the overall quality of Zhenqi Fuzheng preparation including peak attribution,fingerprint,the spectrum-effect relationship and fast quantitative method.It provides theoretical basis for clinical efficacy and safety evaluation for Zhenqi Fuzheng preparation.