Study On Preparation Process And Quality Standards Of Yang-xin-tong-luo Capsule

Objective: To research the preparation technology and establish the quality standardsof Yang-xin-tong-luo capsule. Methods:(1) To optimize the extraction process parametersof Salvia miltior rhiza bge and others medicinal materials by waters. The content ofsalvianolic acid B and dry extraction were regarded as the determination indexes.Usingthe single factor test and orthogonal design to study the extraction process.Theextractionthe quantity of solvent and extraction time were observed.(2) To optimize theextraction process parameters of Ligusticum chuanxiong Hort and others medicinalmaterials by ethanol. The content of ferulic acid, the total flavonids and dry extractionwere selected as the determination indexes. Using the single factor test and orthogonaldesign to study the extraction process. The quantity of solvent amount, ethanol contentand extraction time as influencing factors.(3) To optimization of the refinement, we usedthe salvianolic acid B retained rate and extract reduced rate as evaluation index.(4)Researched the moulding technology of Yang-xin-tong-luo.(5) All species of prescr-ibtion herbs of Yang-xin-tong-luo capsule identified by TLC.(6) HPLC was used todetermine the content of salvianolic acid B and ferulic acid. For alvianolic acid B theoptimal chromatographic conditions include the mobile phase consisting of a mixture ofmethanol acetonetrile formic acid: water (1:59)(26:8.5:65.5), the UV detection wavele-ngth was at286nm.For ferulic acid the mobile phase consisting of a mixture ofmethanol-1%glacial acetic acid and the UV detection wavelength was at321nm.All of theabove at a flow rate of1.0mL/min at30℃and the injection volume were10μL. Result:(1)The optimal of water extraction conditions were as follows: extraction three times, evertime adding12-fold volume of water and each time continuing1.5hours.(2) Theoptimized conditions of extraction process were reflux three times, ever time14foldvolume of adding60%ethanol for2.0hours each time.(3) Its optimum refinementprocess of water extraction decompression concentrate was80℃and medicine physic liquor ratio on1:8,4000r.p.m-1,centrifugation20min.(4) The temperature of alcoholeextraction and water extraction decompression concentrate was70℃and80℃, anddryness of alcohole extract and water extract within60℃a nd the vacuum was0.07-0.08Mpa vacuum desiccation.(5) Adding10%extractum power of Fomes officinalisAmes as adjuvants and92%or93%ethanol as adhesives to make granule.(6) In the studyof the quality standard, the Thin Layer Chromatograph of Salvia miltiorrhiza bunge,Ligusticum chuanxiong Hor., Corydalis yanhusuo and W.T.Wang.Fomes officinalis Ameswere taken as the text of quality standard.(7) The determination methods of ferulic acid,salvianolic acid B have been established by HPLC, the result appear that the linearity,reproducibility and stability of the method were good. Conclusion: The preparation processof Yang-xin-tong-luo was reasonable and feasible; the quality stangard was simple, stable,reliable and controllable.