Study On The Canghuopingwei Granules

Canghuopingwei Granule is a preparation of curing chronic gastritis and bile refluxgastritis with Chinese traditional medicine.It is composition of ten herbs. on the basis ofCanghuopingwei decoction, we studied on the new medicine—CanghuopingweiGranules with treating chronic gastritis and bile reflux gastritis.The main parts of this workwere as follows.1. Study on the Preparation Technology of Canghuopingwei Granule1.1.Study on the Extracting Technology1).With magnolol and honokiol as the assessm entindex,the schemes forextracting phenolic materials from Magnolia officinalis were studied by orthogonaldesign.The results showed that the optimal scheme to exract magnolol and honokiol wasas follows. The highest extracting rate and the best sepration effect were obtained underthe conditions of70%ethanol11times as the reagent soaking for1h,refluxing for2h,filtration,then residue plus10times70%ethanol to reflux for2h,and twice was moreeffective.2).With extracting time as the assess entindex, studying on the best time ofextracting the volatile oil. The result showed that extracting5h is the best time.3).To establish an extraction of paeoniflorin from Radix Paeoniae Alba and othersix herbs as traditional Chinese medicine. The paeoniflorin in Radix Paeoniae Alba wastaken as a evaluating marker and was determined by HPLC, the effects of differentsolvents and extraction on extraction efficiency of the paeoniflorin were systematicallyinvestigated. And also the orthogonal test was further used to optimize the extractingconditions.The reflux extraction with80%ethanol seven times as much as the RadixPaeoniae Alba amount for twice was more effective.To separate impurities from the solution of water extracting,the result showed thatthe relative density of extracts is1.15(detecting on55～60℃), containing alcohol was70%,asiding for24h, seprating the above of water extracting then concentrating.Themethod can get the higher paeoniflorin.4).To suty the best β-CD inclution process for the volatile oil. The ratio ofinclusion and the oil bearing o f the inclusion were used as the index of the inclusionprocess.The optimum condition for inclution was as follows: The proportion ofoil,β-CD and water was1mL:10g:220mL, and the temperature and time were40℃ and1h,cooling,then refrigerate on the temperture under10℃for24h.The methodcan decrease the volatilization of the oil.1.2Study on the formulation process of Canghuopingwei granulesTo establish the best formulation process of Canghuopingwei Granule. Probeeffects of different matched proportion of soluble starch and dextrin on granularformulation’s mouldability， dissolvablity and the absorption of moisture afterpelletizing，optimize out of the best auxiliary material and matching of CanghuopingweiGranule. The forming process optimized is scientific and reasonable，the quality ofgranule is better，and the rate of forming is high.2. Study on the quality standars of Canghuopingwei granules1). To establish the quality standard of Canghuopingwei granule by thin-layerchromatography.It includes9kinds of herbs:Atractylodes lancea,Bletilla striata,Citrusreticulate blanco,Paeonia lactiflora,Hordum vulgare,etc; and6kinds of herba ingranules: Atractylodes lancea, Patchouli, Licorice, Magnolia,etc. The method is precise,repeatable, accurate and can be used for the quality of Canghuopingwei granulescontrol.2).To determine Canghuopingwei granule of magnolol and honokiol by HPLCmethod.The chromatographic conditions included that C18(250mm×4.6mm,5μm) wasused as chromatographic column by HPLC isolation; the methanol:water(78:22)asmobile phase; the flow rate was1.0mL/min, the detection wave length was294nm, the column temperature was25℃. The method is simple, precise, repeatable,rapid detection, accurate and can be used for the quality of Canghuopingwei granulescontrol.3).To determine the Canghuopingwei granule of paeoniflorin by HPLCmethod.The chromatographic conditions included that C18(250mm×4.6mm,5μm) wasused as chromatographic column by HPLC isolation; the acetonitrile:0.1%phosphate(14:86) asmobile phase; the flow rate was1.0mL/min, the detection wave length was230nm, used for gradient elution,the column temperature was25℃. The method issimple, precise, repeatable, rapid detection, accurate and can be used for the quality ofCanghuopingwei granules control.3. Study on the stability of Canghuopingwei granuleStability of Canghuopingwei granules is studied by means o f acceleration test andlong term trial.To invest the granules on the character, identification, particle size,melting,etc.The result showed that the granule meet the quality as well as nationalstandards. 4).Study on parmocogy effect of Canghuopingwei granule4.1.Study on the efficacy of Canghuopingwei granuleTo investigate therapeutical effect of chronic gastritis in rats with Canghuopingweigranule. In models of chronic gastritis and bile reflux gastritis in rats, decreased acidityof gastric juice was reversed with Canghuopingwei Granules treatment. Gastricpathologic examination suggested that Canghuopingwei granules could markedlyattenuate the pathological changes of gastric mucosa injury in rats. CanghuopingweiGranules had remarkably therapeutical effect on chronic gastritis and bile reflux gastritisin rats.4.2.Study on the acute toxicity of Canghuopingwei granuleTo investigate the acute toxicity in rats with Canghuopingwei granule. In models ofacute toxicity in rats, it is obtain that the reduced crude drugs quantity is1240g/kg.Theresult showed that Canghuopingwei granule had no significant acute tox icity.