| Fufang huanggan granule(FHG)is composed of six traditional Chinese medicines(rhubarb,astragalus,processed licorice root,dried ginger,bei chaihu and aconite root).It is intended to be developed into six new Chinese medicines in the "Administrative Measures for the Registration of Drugs",aiming at the treatment of chronic renal failure(CRF).As an important part of the research and development of traditional Chinese medicine(TCM),the new TCM compound medicine is the focus of the research and development of new traditional Chinese medicine.In the face of many major and difficult diseases,chronic diseases,influenza virus diseases,etc.Western medicine treatment effect is not satisfactory,and there are serious side effects,and traditional Chinese medicine in many aspects has unique treatment.The new drug of Chinese herbal prescription greatly reflects the advantages and characteristics of traditional Chinese medicine,depending on the integration of traditional chinese medicine’s dialectical theory and the holistic view,the new drug of chinese herbal prescription will surely achieve a greater breakthrough.This article takes Fufang Huanggan Granules as the research object.First,it conducts quality research on the six Chinese traditional medicines.Second,establish the quality standard of Fufang huanggan granules.Finally,it uses the network pharmacology method to obtain the effective active ingredients of Fufang Huanggan Granules,so as to make the formulation of Fufang huanggan granule quality standard more reasonable.The main research contents were as follows:(1)Quality evaluation of Fufang Huanggan Granules decoction pieces:According to the requirements of the 2015 edition of the pharmacopoeia,each batch of Fufang Huanggan Granules decoction pieces were tested.Given the king medicine astragalus in the low content of astragalus armour glycosides,poorrepeatability problem,investigated 40% ethanol for different elution volumes,the elution flow rate of D101 macroporous adsorption resin,the leakage curves of 10 kinds of D101 macroporous adsorption resin,and determined the content of medicinal residues after soxhlet reflux,It was found that the elution flow rate,the choice of D101 macroporous resin,and the extraction method during the preparation of the test product were questionable.In addition,by using the method of astragalus TLC identification for reference,the influences of two different sample preparation methods,D101 macroporous adsorption resin and neutral alumina column chromatography,on the content of astragaloside IV in astragalus samples were compared,which laid a foundation for more reasonable control of the quality of astragalus decoction pieces in the future.(2)Study on Quality Standard of Fufang Huanggan Granules Intermediate:Thin layer exploration of rhubarb,licorice root and astragalus in Fufang Huanggan Granules intermediate,establishing identification methods for rhubarb and licorice.Methodological study on the active ingredient astragaloside IV in intermediates,to lay the foundation for the quality of Fufang Huanggan Granules.At the same time,taking total anthraquinone as the research object,the quality and mass transfer of five anthraquinones in the decoction solution,concentrated solution and spray-dried powder were investigated,which provided support for the process stability of Fufang Huanggan Granules.(3)Study on Quality Standard of Fufang Huanggan Granules:This chapter established a thin layer identification method for rhubarb,licorice and dried ginger of Fufang Huanggan Granules,and the diester type aconitine was examined.Method for determining the content of main chemical components aloe emodin,rhein,emodin,chrysophanol,emodin methyl ether,astragaloside IV,glycyrrhizin and glycyrrhizic acid by using HPLC,established a fingerprint of Fufang Huanggan Granules to control the quality of the granules.Clarify the law of mass and mass transfer from the source of the decoction to the finished product’s active ingredient group,further explaining that the preparation process is stable and reliable.At thesame time,it also provides research ideas and methods for the study of the law of mass-mass transfer of new traditional Chinese medicine compounds.(4)Internet pharmacology research:To Fufang Huanggan Granules as the research object,using the network pharmacology method to establish Fufang Huanggan Granules "single herbs-active ingredient-targets-disease" network,It provides a theoretical basis for the potential mechanism of compound huanggan granule in the treatment of chronic renal failure.It is predicted that active components such as astragaloside IV and emodin are closely related to chronic renal failure diseases,and the scientific and reasonable selection of index components for compound Huanggan granules will be verified and analyzed.Conclusion : Based on the research of Fufang Huanggan Granules decoction pieces,and the establishment of the draft quality standard of Fufang Huanggan Granules,the effective ingredients of Fufang Huanggan Granules were obtained based on the network pharmacology method to further verify the rationality of Fufang Huanggan Granules index composition selection,and provide reference for the research and development of TCM compound new drugs. |