六味地黄丸(浓缩丸)质量标准英文版

六味地黄丸(浓缩丸)质量标准英文版

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时间:2018-08-02

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1、LiuweiDihuangPills(concentratedpills)六味地黄丸(浓缩丸)PinyinLiuweiDihuangWanIgredientsPreparedRehmanniaRoot120g;FructusMacrocarpii60g;CortexMoutanRadicis45g;RhizomaDioscoreaeOppositae60g;Poria45g;RhizomaAlismatis45gProcedureDistillateCortexMoutanRadiciswithwatervapof

2、orabstractingvolatilityingredients;Decoctthegruffs,FructusMacrocarpii20g,PreparedRehmanniaRoot,PoriaandRhizomaAlismatiswithwatertwice,2hoursforeverytime,filter,combinethefiltrated,concentratedthemtoextract;pulverizeRhizomaDioscoreaeOppositaeandexcessofFructusM

3、acrocarpiitofinepowder,sifting,mixthoroughly,addtheaboveextractandvolatilityingredientsofCortexMoutanRadicis,mixthotoughly,maketopills,dry,polishing.DescriptionBrownishtoblackconcentratedpills,taste,sweat,acid,slightlybitter.Identification(1)Microscopical:Epid

4、ermalcellsofpericarporange-yellow,polygonalinsurfaceview,withsomewhatbeadedanticlinalwalls.Starchgranulestriangular-ovoidoroblong,24-40µmindiameterhilashortcleftVshaped.(2)Pulverize5gofthepills,heatunderrefluxwith20mlofetherfor1hour,filterandexpelether.Dissolv

5、etheresiduein1mlofacetoneasthetestsolution.DissolvepaeonolCRSinacetonetoprepareasolutioncontaining1mgperml.asthereferencesolution.Carryoutthemethodforthinlayerchromatography(AppendixⅥB),usingsilicagelGasthecoatingsubstanceandcyclohexaneandethylacetate(3:1)asth

6、emobilephase.Applyseparately5-10μlofeachofthetwosolutiontotheplate.Afterdevelopingandremovaloftheplate,dryinair,spraywith5%ferricchlorideinethanolacidifiedwithhydrochloricacidandheattothespotsclear.Thespotinthechromatogramobtainedwiththetestsolutioncorresponds

7、inpositionandcolourtothespotinthechromatogramobtainedwiththereferencesolution.(3)Pulverize10gofthepills,dissolveitwith100mlofwater,heattoboil,allowtostandforcool,filterinabsorbentcotton,washthefiltratewithtwo-30mlquantitiesofacetidin,combinethefiltrate,evapora

8、tethefiltratetodryness,dissolvetheresiduein1mlofmethanolasthetestsolution.Prepareasolutionof4gofPreparedRehmanniaRootreferencedrugand60mlwater,decoct30minutes,standforcool,filterwi

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