六味地黃丸(濃縮丸)質(zhì)量標準英文版

六味地黃丸(濃縮丸)質(zhì)量標準英文版

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時間:2018-07-13

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1、LiuweiDihuangPills(concentratedpills)六味地黃丸(濃縮丸)PinyinLiuweiDihuangWanIgredientsPreparedRehmanniaRoot120g;FructusMacrocarpii60g;CortexMoutanRadicis45g;RhizomaDioscoreaeOppositae60g;Poria45g;RhizomaAlismatis45gProcedureDistillateCortexMoutanRadiciswithwatervapoforabstractingvolatilityingre

2、dients;Decoctthegruffs,FructusMacrocarpii20g,PreparedRehmanniaRoot,PoriaandRhizomaAlismatiswithwatertwice,2hoursforeverytime,filter,combinethefiltrated,concentratedthemtoextract;pulverizeRhizomaDioscoreaeOppositaeandexcessofFructusMacrocarpiitofinepowder,sifting,mixthoroughly,addtheabove

3、extractandvolatilityingredientsofCortexMoutanRadicis,mixthotoughly,maketopills,dry,polishing.DescriptionBrownishtoblackconcentratedpills,taste,sweat,acid,slightlybitter.Identification(1)Microscopical:Epidermalcellsofpericarporange-yellow,polygonalinsurfaceview,withsomewhatbeadedanticlina

4、lwalls.Starchgranulestriangular-ovoidoroblong,24-40μmindiameterhilashortcleftVshaped.(2)Pulverize5gofthepills,heatunderrefluxwith20mlofetherfor1hour,filterandexpelether.Dissolvetheresiduein1mlofacetoneasthetestsolution.DissolvepaeonolCRSinacetonetoprepareasolutioncontaining1mgperml.asthe

5、referencesolution.Carryoutthemethodforthinlayerchromatography(AppendixⅥB),usingsilicagelGasthecoatingsubstanceandcyclohexaneandethylacetate(3:1)asthemobilephase.Applyseparately5-10μlofeachofthetwosolutiontotheplate.Afterdevelopingandremovaloftheplate,dryinair,spraywith5%ferricchlorideine

6、thanolacidifiedwithhydrochloricacidandheattothespotsclear.Thespotinthechromatogramobtainedwiththetestsolutioncorrespondsinpositionandcolourtothespotinthechromatogramobtainedwiththereferencesolution.(3)Pulverize10gofthepills,dissolveitwith100mlofwater,heattoboil,allowtostandforcool,filter

7、inabsorbentcotton,washthefiltratewithtwo-30mlquantitiesofacetidin,combinethefiltrate,evaporatethefiltratetodryness,dissolvetheresiduein1mlofmethanolasthetestsolution.Prepareasolutionof4gofPreparedRehmanniaRootreferencedrugand60mlwater,decoct30minutes,standforcool,filterwi

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