ISO 04564-2023.docx

INTERNATIONA1.STANDARDISO4564editionFirst2O23-O5Traditiona1.Chinesemedicine一Scute1.1.ariabaica1.ensisrootMdecineIraditionne1.1.echinoise-RacinedeScute1.1.ariabaica1.ensis©ISO2023COPYRIGHTPROTECTEDDOCUMENT©ISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.o啪InPSd1.Mc;GeatrOn1.(nm11nr1amaqmr6pW11opyp>iiuonmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountr)oftherequester.f),WV>fifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForewordivIntroductionv2 Scope13 Normativereferences14 Termsanddefinitions15 Descriptions1Requirements25.1 Genera1.characteristics25.2 Morpho1.ogica1.features35.3 Microscopicidentification35.3.1 Transversesection5.3.2 Powder35.4 Moisture3MAoI-SoIubIeextractives5.7 Thin-Iayerchromatogramidentification45.8 Contentofmarkercompounds4Samp1.ing4Testmethods41.1 Macroscopicidentification41.2 2F1.CrOSCOP1.C1.dent1.fiCston.一一134567-ZZDeterminationofmoistucyntntDeterminationofethano1.-so1.ub1.eextractives4Thin-Iayerchromatogramidentification41.8 Determination3548 7.9Determinationofpesticideresiduesconteis59 -I1.eStreport5IQPackaging,storageandtransportationSMarkingand1.abe1.1.ing5Annex A (informative)Thin-Iayerchromatogramidentification.一6Annex B (informative)Determinationofmarkercompounds8Annex C (informativeReferencedinformationofnationa1.andregiona1.requirementsonScute1.1.ariabaca1.ensisroot10Bib1.iography12ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsttiugh(ISOtnnhnfaaibif1.4m11rhvcekuHMf1.pbcingbodyhitf1.crdtiSMi6tandjGSnOWmitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceare9瑟修魄M槛OfISO1.EC(陶曲俺奥小卜如伏龄&盘柏螂副N醵观M曲er%c°rdance用Fhtheeditoria1.ru1.esoftheISO/IECDirectives.Part2(secwww.iso.org/direc1.ives).AnytradeusedinthisR褥曲Onrights.d限腺顿n膈熄居御½g嘏郎吸R副i*刷祖沙doc1.1.般:棉骁i圈赧s.subjectofanypatentrightsidentifiedduringthedeve1.opmen)3th»do<u帘QAtWiUbeintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(seewww.iso.org/patents).constitutenameendorsement,documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand族aR涸枭取OrRanfWMWass忠jSW窿inweW¾1.ft1.沁nBarP挑Jdead虐¾e盘w¼w.iso.oiso/forewoId.htm).ThisdocumentwaspreparedbyTechnica1.CommitteeISO/TC249,Traditiona1.Chinesemedicine.AnyfeedbackorquestionsonthisdocumentShCY1.dhS1.hr'rnationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.iso.org/members.htm1.IntroductionScute1.1.ariahaica1.ensisisatraditiona1.herba1.medicinewiththecommonnameBaika1.sku1.1.caporQhineSeR1.akidkifP曲nariQjpMftHSfdiadkrireehgHerfuiur枷nk即ri"tt;,KCnreiMRrieChina,fundamenta1.herbsusedintraditiona1.Chinesemedicineandisknownashungq(n(黄苓)inChinese.Itsrootisthemainmedicina1.part.Afe4三U阉加睫研翻SeSMWiCine碇indu<BItHensMw豺RMifnxi的期曲舐静effeifehighcho1.estero1.,atherosc1.erosis,rabies,epi1.epsy,nervoustension,a1.1.ergies,skininfections,inammationandspasms.Itisa1.sousedforthetreatmentOfhepatitis1atherosc1.erosis,hypertension,hyper1.ipidemia,type2diabetes,dysentery,u1.cerativeco1.itisandrespiratorydisorders.Thepurposeofthisdocumentistoprovidesystematicandcomprehensivemethodsforthequa1.itycontro1.ofScute1.1.ahabaica1.ensisft>rdirectmedicina1.andpharmaceutica1.use.JttSidtiondsSimp1.eA1.wintionCanstandardiifiwnqj1.ieaniiridardsnofiona1.ab<fona1.va1.ur*,givertWtteAi11exCgiveTraditiona1.ChinesemedicineScute1.1.ariabaica1.ensisroot1ScopeThisdocumentspecifiesminimumrequirementsandtestmethodsforrootofScute1.1.ariabaica1.ensis1.whichisderivedfromcu1.tivatedScute1.1.ariabaica1.ensisGeorgi.Thisdocumentapp1.iestoScute1.1.ariabaica1.ensisrootthatareso1.dandusedasnatura1.medicinesininternationa1.trade,inc1.udingChinesemateriamcdica(who1.emedicina1.materia1.s)anddecoction和CeSNdFttWt店Oe甲包心T坦眦es长秘钝树阻瓦棚如na1.m仲格限府融哂蝴租用的缶蛇his11Ment.用陋健册nrefi<fta例W1.a崛eedif1.bna1.1.N(噂p1.iesMentundatedreferences,the1.atesteditionofthereferenceddocument(inc1.udinganyamendments)app1.ies.medicineDeterminationofheavymeta1.sinherba1.medicinesusedinISO/TS21310,Traditiona1.ChinesemedicineMicroscopicexaminationofmedicina1.herbsU)21371rTraditiona1.ChinesemedicineIMheIIingrequirementsofproductsintendedforora1.ortopica1.ISO22217rTraditiona1.ChinesemedicineStoragerequirementsforrawmateria1.sanddecoctionpiecesDeterminationofpesticideresiduesinnatura1.productsbygasjfraphyTraditiona1.Chinesemedicine一f5037723rTraditiona1.ChinesemedicineGenera1.requirementsforherba1.rawmateria1.andmateria3TermsanddefinitionsForthepurposesofthisdocument,thefo1.1.owingtermsanddefinitionsapp1.y.ISOandIECmaintaintermino1.ogydatabasesforuseinstandardizationatthefo1.1.owingaddresses:ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps:/www.iso.org/obp371IECEiec1.ropedia:avai1.ab1.eat4U>/batchsamp1.esofnomorethan5OOOkgco1.1.ectedfromthesameparticu1.arp1.aceatthesame1.ime4S0D峥HPtiOnS23972:20213IJThep1.antanddriedScute1.1.ariabaica1.ensisrootareshowninFigure1.p1.antofScuie1.1.anabaica1.ensisCtransversesectionoftheprootBdriedtaprootDtaprootwithout1.atera1.rt1Ooweringbranch10wartyprot11ding2ower111.atera1.rootscar31.eaf12epidermis4stem13vascu1.arcambium5rhizome14ph1.oem61.atera1.root15xy1.em7taproot16ray8root1.ets17stemscar9stemscarIfirootscarFigure1StinctureofScute1.1.ariabaica1.ensisroot5Requirements5.1 Genera1.characteristicsThefo1.1.owingrequirementssha1.1.bemetbeforesamp1.ing.b)nakcdpresenceof1.ivingpermitted.rnou1.dyrootandexterna1.contaminantswhicharevisib1.etothe5.2Morpho1.ogica1.featuresb)Thewho1.etaprootis8cmto25cm1.ongand1cmto3Cmindiameter.1.ongitudina1.striationsandfinewrink1.es.e)brownish-b1.ack,witheredreddish-browninthecentre.Thecentra1.partofano1.drootisdarkbrownor5.3Microscopicidentification5.3.1 Transversesectionce1.1.s.C)Withcambiumraysre1.ative1.ybroad.vesse1.soccursing1.yorgrouped,surroundedbyxy1.emfibrebund1.es,1.ayersofwe1.1.-orderedcorkce1.1.senc1.osingthevesse1.s.5.3.2 Powderb)diameter,andthick-wa1.1.ed,scatteredsing1.ypit-cana1.s.bund1.es.Itis60mto250m1.ong,9mto33mwa1.1.ed.Xy1.emfibresaremost1.ybrokenwithsparseob1.iquepits.e)Vesse1.saremain1.yreticu1.ated,24rnto72tnindiameter.5.4 Moisture5.5 Tota1.ashTheeyesha1.1.notbeinsects.a) Therootisconica1.andtwistedasshowninFigure1.c) Theoutersurfaceisbrownish-ye1.1.owordarkye1.1.owrbearingsparse,wartytracesofroot1.ets.Theupperpartisrough,withtvristed1.ongitudina1.wrink1.esorirregu1.arreticu1.a；the1.owerparthasd) Thetextureishard,fragi1.eandeasi1.ybroken.Thefractureye1.1.ow,ho1.1.owed.Bb) Theph1.oemisbroad,scatteredwithsing1.eorgroupsofstonece1.1.s.Thexy1.emisdistinct.Xy1.emd) Interxy1.arycorktissueisfoundinthexy1.emofrootsofp1.antso1.derthantwoyearso1.drwithsevera1.e) Parenchymace1.1.sarerep1.etewithstarchgranu1.es.ninPh1.oemfibresisfusiform,withfineorC)Stonece1.1.sareSuborbicu1.ar,Subsquarcorrectangu1.ar,re1.ative1.ythick-wa1.1.edOrhcavi1.ythick-d)Corkce1.1.sarebrownish-ye1.1.ow,po1.ygona1.insurfaceview.f) Starchgranu1.esareabundant.Theyare2mto10m.Thesimp1.egranu1.eisspheroida1.andhi1.umisdistinct.Thecompoundgranu1.esarecomposedof2-3units.Themoisturecontentshou1.dnotbemorethan15,0%.Themassfractionoftota1.ashshou1.dnotbemorethan6,0%.5.6 Ethano1.-so1.ub1.eextractivesThemassfractionofextractivesshou1.dbedetermined.5.7 Thin-IayerchromatogramidentificationTheidentificationOfbaica1.inwiththin-1.ayerchromatogram(T1.C)sha1.1.presentspotsfromthetestandf8i(tQieD1.i0i(>nriiFkerpo11tp<Mindswiththesameco1.our.1就KfiftFyt1WHrfe1.a1.scompound(三)suchasbaica1.in,baica1.einandWogOninsha1.1.bedetermined.gy俚般瞰悭g般盥UChasarsenicmercury,1.ead,cadmiumsha1.1.bedetermined.靛FPIingmethOdSspecifiedheSgftVP1.fpesticideresiduessha1.1.bedetermined.inISO23723sha1.1.app1.y.7.1 MacroscopicidentificationTakesamp1.esofnot1.essthan500gfromeachbatchrandom1.y.Thesesamp1.essha1.1.beexaminedbyt74KedMiQudof11o(identidttbh孑濯1%骅w½ttbns做"Iedftittfra的Ientsha1.1.app1.y.多隔也或股IWmMbns假medCdfittftchttapp1.y.福0做邨fWftftrt>ns限用et1.9曲蹴IubIeS三KractivesThetestingspecifiedISO23723sha1.1.app1.y.7.6 Thin-IayerchromatogramidentificationW例哨hdH6A3界椭GmcompoundsSeeAnnexBforadditiona1.information.7.8 Determinationofheavymeta1.scontentsThetestingmethodspecifiedinISO18664sha1.1.app1.y.7.9 DeterminationofpesticideresiduescontentsThetestingmethodsspecifiedinISO22258sha1.1.app1.y.8TestreportForeachtestmethod,thetestreportsha1.1.specifythefo1.1.owing：a) a1.1.informationnecessaryforthecomp1.eteidentificationofthesamp1.e；b) areferencetothisdocument,i.c.ISO4564:2023;C)thesamp1.ingmethodused；d) thetestmethodused;e) thetestresu1.t(三)used：0a1.1.operatingdetai1.snotspecifiedinthisdocument,orregardedasoptiona1.,togetherwithdetai1.sofanyincidentswhichhavepossib1.yinf1.uencedthetestresu1.t(三);助Pabkd雄n,tbtEgeandtransportationShftPaCk能W?即Ahenot用涮毡REO11粒触沙r°r相硼IF做heproductandsha1.1.notcontainsubstancesThestorageconditionspecifiedinISO22217sha1.1.app1.y.Theproductsha1.1.be1.ong-distancede1.ivery.protectedfrom1.ight,moisture,po1.1.utionandentryofforeignsubstancesduring10Markingand1.abe1.1.ingThefo1.1.owingitemssha1.1.bemarkedor1.abe1.1.edonthepackageinaccordancewiththemethodspecifiedinISO21371:a) thegradeoftheproduct；b) a1.1.qua1.ityfeaturesindicatedinC1.ause5;c) themaximumweightofthebatchandthesamp1.es；d) thecountryandprovinceorstateoforiginoftheproducts；e) theexpirydateoftheproducts;Qthestoragemethodused.AnnexB(informative)Determinationofmarkercompounds8.1 Preparationoftestso1.utionWeigh250gofsamp1.etogrindandpassitthroughan80meshorfinersieve.Weighaccurate1.y0,3gfore1.i<duftrnpteQdctt0jn1.nt1.V(1.etf1.c6tao1.,thseUnddiIOCntt1.INgM>dmk11hethrev.hafchwithatinyamountof70%ethano1.andfi1.terthewashingstothevo1.umetricf1.ask.Di1.utewith70%ethano1.tovo1.umeandmix.Accurate1.ytransfer1m1.toa10-m1.vo1.umetricf1.ask,di1.utewithmethano1.tovo1.umeandmix.8.2 Preparationofreferenceso1.ution曲疝Vethe都搬於StF三J的自"Mfff1.眦MthSUQ洲趣布新“儿初&yamTaH咻板Oninintomethano1.toTab1.eB.1.Referenceso1.utionCompoundConcentrationmg/m1.Baica1.e1.nI1.(CHO)0.016WogoninIII(Ci6H12O>)0,0088.3 Chromatographicconditions8.3.1Stationaryphase:octadecy1.si1.anebondedsi1.icage1.orequiva1.entasana1.ysingco1.umn.8.3.2 Size:1=150mrn,0=4,6mrnrpartic1.esize=3.0rn.8.3.3 Mobi1.ephase.8.3.3.1 Mobi1.ephaseA：0,2%phosphoricacidinmethano1.8.3.3.2 Mobi1.ephaseB:0,2%phosphoricacidinwater.8.3.3.3 Programofgradiente1.utionasshowninTab1.eB.2.8.3.4Aowrate:1,0m1.min.8.3.5 Detector280nm.8.3.6 Injectionvo1.ume:101.8.3.7Temperatureofco1.umnoven：Typica1.chromatographicconditionsminvo1.umicfractioninpercentVoIUmiCfractioninpercent3to4410008.4 Contentca1.cu1.ationofmarkercompounds8.4.1100Csistheaveragecontentinthesamp1.e(mgm1.);34m8.4.2 MKeyhaica1.emFigureB.1.Typica1.HP1.CchromatogramsofScute1.1.ariabaica1.ensisrootIrightsreservedTimeMobi1.ephaseAMobi1.ephaseBIOto38SOto7050to30Tab1.eB.230.(B1.)Tbe相册Jagecontentofbaica1.in,Wn(1.WM)%Isca1.cu1.atedusingFormu1.a(B.1.):whereisthemassofScuie1.1.ariabaica1.ensisroottakentopreparethesamp1.eso1.ution(g);isthemoisturecontentofthesamp1.e(%).mAU800-Atypica1.HP1.CchromatogramisshowninFigureB.1.700-600-500-400-300-200-100-0wogoninAnnexC(informative)Referencedinformationofnationa1.andregiona1.requirementsonScute1.1.ariabaica1.ensisroot惭累r51.countriesandregionsgivetheirownrequirementsonScute1.1.ariabaica1.ensisrootasshowninTab1.eC.1.Nationa1.andregiona1.qua1.ityrequirementsofScute1.1.ar1.abaica1.ensisrootItemChinesePharmacopoeia,2020EditionEuropeanPharmacopoeia,IOthEditionIapanesePharmacopoeia,18thEditionKoreanPharmacopoeia,12thEditionChineseHongKongChineseMateria1.McdicaStandardsChineseTaiwanHerba1.Pharmacopoeia,3rdEditionScute1.1.ariabaica1.ensisScute1.1.ariabaica1.ensisScute1.1.ariabaica1.ensisScute1.1.ariabaica1.ensisScute1.1.ariabaica1.ensisScute1.1.ariabaica1.ensistivcsExtracmeta1.sHcav)KeyNotapp1.icab1.eTab1.eC.1.(continued)itemChinesePhannaco-POeia,2020EditionEuropeanPhannaco-Poeia,IOthEditionJapanesePharmaco-Poeia,18thEditionKoreanPharmacopoeia,12thEditionChineseHongKongChineseMateria1.MedicaStandardsChineseTaiwanHerba1.Pharmacopoeia,3rdEdition-.-i-i-iPCtkideQes向(A1.XtrtiM1.x<!Containersandstorageanddryp1.ace.KeyNotapp1.icab1.eBib1.iography(1 ISO21300,Traditiona1.ChinesemedicineGuide1.inesandspecificationforChinesemateriamedico(2 ISO23972,Traditiona1.ChinesemedicineZingiherofficina1.erhizomeIMFWRR涧相弼IjRfA祁曲FbTRiP胡湖刃届%ofthePeop1.e'sRepub1.icofChina.Part1.(4 EuropeanPharmacopoeiaCommitteeEuropeanPharmacopoeia.E1.eventhEdition.Strasbourg:EuropeanDirectorateforthequa1.ityofMedidnesSHea1.thCare,2022(5 CHINESEHONGKONGMATERIAMEDICASTANDARDS(HKCMMS)OFFICE,ChineseHongKongChineseMateriaMedicaStandards.HongKong:DepartmentofHea1.th,HongKongSpecia1.AdministrativeRegion,ThePeop1.e'sRepub1.icofChina,Vo1.3.2005(6 MinistrjfofFoodandDrugSafetyTheKoreanPharmacopoeia.Twe1.fthEdition.ChungcheongBukdo：TheMinistryFoodandDrugSafety,2020(7三rihkt1.onmb葩，HKmdcoeW白ditioX'捌阴站ePharmacopoeia.Tokyo:Ministryof8JCHINESETaiwanPharmacopoeiaCommitteeCHINESETaiwanHerba1.Pharmacopeia.Taiwan:MinistryofHea1.thandWe1.fare,Taiwan,ThePeop1.e,sRepub1.icofChinatFourthEdition.2022