The Preparation Process And Study On Quality Standard Of Bushen Huoxue Granules

Objective: To reform the traditional mixture formulations of Bushen Huoxue Decoction,to study the traditional Chinese compound medicine Bushen Huoxue granule for treating “chronic heart failure".The preparation technology,quality standard,fingerprint and stability of the granules were investigated.Providing experimental data and quality assurance for the follow-up research and industrial production of new chemical type.Methods: According to the effective components and chemical properties,the ten medicinal herbs in the prescription were divided into two groups: water extraction group and alcohol extraction group.By L9(34)orthogonal test method,Take the content of effective components in the two groups(isopsoralen,tanshinone A,paeoniflorin,total polysaccharide)as the index,optimizating the extraction technology of particle.Take the molding rate and particle appearance as indexes,the optimum preparation process was investigated by using the amount of excipient,wetting agent and flavoring agent;TLC was used for qualitative identification of Chinese herbal medicines.In order to simplify the identification procedure,the author experimentally explore multi-components by single marker(QAMS)TLC identification technique;The effective components of adjuvant drug psoralen was made quantitative analysis and Preliminary exploration on the fingerprint qualitative identification of Bushen Huoxue granules.Results: The optimum extraction process and forming process of prescription medicine were obtained through experiments;To establish the TLC method of salt psoralen,Salvia miltiorrhiza and astragalus,radix paeoniae rubra,Fructus Corni and QAMS TLC identification technique.The author established content determination method for adjuvant drug psoralen of preparation.chromatographic conditions of fingerprint chromatogram were preliminarily determined.A total of 19 common peaks were measured and a qualitative analysis was performed on 5 of them.Finally,the preliminary stabilityof the preparation was tested.Conclusion: Bushen Huoxue granule preparation process is simple and reasonable,accurate and feasible;TLC,HPLC content determination and fingerprint qualitative method is stable and reliable;it provides quality assurance for clinical use and has great market prospects.