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cps

Pummelopeelisthedriedunripeoralmostripeexocarpofcitrusgrandis“tomentosa”orcitrusgrandisosbeck

Chemicalidentification

Shake0.5gofthepowderwith5mlofethanolfor5minutesandfilter.Evaporatethefiltratetodryness,adddropwiseantimonytrichloridesaturationsolutionin-chloroformandevaporateagaintodryness.Aviolet-redcolourisproduced.

前言目录

Index索引

Appendices附录

Monographs正文

Generalnotices

ThePharmacopoeiaofthePeople’sRepublicofChinaknownasChinesePharmacopoeiainabbreviationistheofficialgeneralscientificandtechnicalprovisionsfordrugqualitycontrolandadministration.

中华人民共和国药典，简称中国药典，是国家监督管理药品质量的法定技术标准。

WherethePharmacopoeiaisissuedforenforcementbythedrugregulatoryauthorityoftheStateCouncil,thesamedrugstandardofthepreviousPharmacopoeiaortheoriginalnationalstandardshallnotbeused.WhentheChinesePharmacopoeiaisquotedinthiscompendium,itdenotesthecurrenteditionofthePharmacopoeiaofthePeople’sRepublicofChina,exceptwhereaspecificeditionisindicated.

GeneralNoticesserveasthebasicguidelinesfortheproperinterpretationandapplicationoftheChinesePharmacopoeiainqualitycontrol.Itappliestoanyarticles,appendicesandgeneralstatementsrelatedtoqualitycontrolofdrugssoastoobviatereplicationinthiscompendium.TherelatedrequirementsinGeneralNoticesareofficialinthePharmacopoeia.

Thewording“unlessspecifiedotherwise”adoptedinGeneralNoticesandAppendicesindicatesthatappropriaterequirementisadmittedintherelatedmonographwherevertherequirementisnotconformtothatspecifiedinGeneralNoticesorAppendices.

ThedrugcitedinthePharmacopoeiashouldbethoseadmittedinthiseditionofPharmacopoeiasandcomplywiththerequirementsofcorrespondingmonographs.

TheGuidelinesstatedinAppendicesarenotconsideredasofficialrequirementsbutusedasstatementsinprinciplesappliedtotheimplementationofPharmacopoeia,monitoringofdrugquality,andrevisingorverifyingofdrugstandards.

TitlesandArrangements

1.TheChinesetitlesofdrugsadmittedinthemonographsarerecommendedaccordingtotheguidelineforthenomenclatureof“ChineseApprovedDrugNames”.TheChinesetitleofadrugisadoptedasofficialdesignation.Unlessspecifiedotherwise,the“InternationalNonproprietaryName”forpharmaceuticalsubstances（INN）isadoptedastheEnglishtitle.

Titlesoforganicchemicaldrugsareadoptedonthebasisof“GuidelinefortheNomenclatureofOrganicChemistry”publishedbytheChineseChemicalSociety.TheselectionofmainpartofitschemicalstructureisinlinewiththerulesoftheInternationalUnionofPureandAppliedChemistry（IUPAC）.

2.Thechemicalstructureofthedrugsareportrayedaccordingto“GuidelinesforGraphicRepresentationofChemicalFormulae”recommendedbytheWorldHealthOrganization.

3.ThemonographsarearrangedalphabeticallyontheEnglishtitlesofdrugs.MonographsforformulatedpreparationsarefollowedthatofdrugsubstanceontitleinthePharmacopoeia.Monographsofexcipientsarelistedinseparatesection.Appendicesarearrangedintosectionsincludinggeneralrequirementsofformulatedpreparations,generaltestingmethodsandguidelines.

4.Themonographofeachdrugsubstanceordifferentdosageformsisstatedwithrespecttofollowingitems:

（1）Titleofdrugsubstanceordosageforms;

（2）Structuralformulaoforganicchemicals;

（3）Molecularformulaandmolecularweight;

（4）Sourcesorchemicalnameoforganicdrugs;

（5）Contentorpotency;（6）Formularyofthedosageform;（7）Processing;（8）Description;（9）Identification;（10）Test;（11）Assayofcontentorpotency;（12）Category;（13）Strengthorspecification;（14）Storage;（15）Preparation.

Specifications

5.Descriptionreferstotheappearance,odour,taste,solubilityandotherphysicalconstantsofthedrug.

（1）Appearanceofadrugistherequirementsofcolorandexternalappearance.

（2）Solubilityreferstothephysicalpropertyofadrugsubstance.Solventsdescribedunderthemonographandtherelevantsolubilitybehaviorsarestatedforreferenceforpurificationorpreparationofsolutionofadrugsubstance.Requirementshouldbestatedundertheitemoftestofthedrug,ifspecificqualitycontrolisneededforthesolubilitybehaviorofthesolventaccordingly.

Approximatesolubilitiesofdrugsareindicatedbythefollowingdescriptivephrases:

Verysolublereferstothat1g（ml）ofsoluteissolubleinlessthan1mlofsolvent;

Freelysolublereferstothat1g（ml）ofsoluteissolublein1mltolessthan10mlofsolvent;

Solublereferstothat1g（ml）ofsoluteissolublein10mltolessthan30mlofsolvent;

Sparinglysolublereferstothat1g（ml）ofsoluteissolublein30mltolessthan100mlofsolvent;

Slightlysolublereferstothat1g（ml）ofsoluteissolublein100mltolessthan1000mlofsolvent;

Veryslightlysolublereferstothat1g（ml）ofsoluteissolublein1000mltolessthan10000mlofsolvent;

Practicalinsolublereferstothat1g（ml）ofsoluteisnotsolublecompletelyin10000mlofsolvent.

Testingmethod:

unlessspecifiedotherwise,weighoutfinelypowderedsampleormeasureanamountofliquidsample,placethesampleinacertainvolumeofthesolventatatemperatureof25℃±2℃,shakestronglyfor30secondsatanintervalof5minutes.Observethesolubilitybehaviorfor30minutes.Itisconsideredtobecompletelysoluble,ifnoneoftheparticlesordropletofthesoluteisobserved.

（3）Physicalconstantsorparametersincludingrelativedensity,distillingrange,meltingpointormeltingrange,congealingpoint,specificrotation,refractiveindex,viscosity,specificabsorbance,iodinevalue,saponificationvalueandacidvalueetc.,areusefulfortestsforidentificationandgivesomeindicationofthedrugpurity.Itisoneofthechiefcriteriaforappraisalandassessmentofdrugquality.

6.Testingmethodsgivenintheidentificationsectionareintendedtogivesomeofthephysicalandchemicalcharacteristicsofthedrug;theyarenotdesignedtogiveafullconfirmationofthechemicalstructureofthedrug.

7.Testsectionunderthemonographincludesthetestingmethodsandacceptancecriteria,uniformityandpurityrequirementsformanufacturingprocess,whicharerelatedtothesafetyandefficacyofthedrug.Thespecifiedtestingitemsforimpuritiesareframedfromthosepossiblyexistedandproducedinthedrug,whichismanufacturedaccordingtotheapprovedmanufacturingprocessandstoredundernormalcondition,andthoseimpuritiesareneededtobecontrolled,suchasresidualsolventsandrelatedsubstances,etc.Receivingtotherelevantitemsmaybenecessaryforwherethemanufacturingprocessischanged.

Thedrugsubstanceintendedfordirectuseinthepreparationofsterilepowdersforinjectionshouldbetestedaccordingtothecorrespondingrequirementsoftheinjectionandconformwiththerequirements.Preparations,unlessspecifiedotherwise,mustcomplywiththerequirementsstatedunderthegeneralrequirementsforpreparationsofthePharmacopoeia.

8.ThetestingmethodsspecifiedundertheitemofAssayaredesignedtodeterminethecontentofactiveingredientofdrugsubstanceandpreparations,Chemical,instrumentalorbiologicalmethodscanusuallybeadopted.

9.Categoryreferstomainactionanduseofthedrugsoritsclassifiedscientificdesignation.Adrugisnotframedusinginothercategoryonthebasisofexperiencesinclinicalpractices.

10.strengthofpreparationsordosageformsreferstotheamount（unitsofpotency）,labeledamount（%）orcontentofactiveingredientoringredientsineachampoule,tabletorotherunitcontainer,orpreparation.Forinjections,theexpression“1ml:

10mg”indicatesthattheinjectioncontains10mgofactiveingredientin1ml.specificationofweightorcontentmayalsobespecifiedforthemonographsofthepreparationinwhichtheformulaislistedortheconcentrationisindicated.

11.Storagereferstothebasicconditionsforstorageandpreservationofadrug.Itisstatedbythefollowingterms:

protectedfromlightreferstothatadrugshouldbekeptinlightresistantcontainersuchasambercoloredcontainer,oracolorlesstransparentorsemitransparentcontainerwrappedwithblackpaper.

Wellclosedreferstothatthecontainershouldbeabletoprotectthecontentfromextraneousmattersorloseofcontentsonnormalhandingcondition.

Tightlyclosedreferstothatthecontainershouldbeabletoprotectthecontentsfromefflorescence,deliquescence,volatilizationorinterferenceofextraneousmatters.

HermeticallysealedorTightlysealedreferstothatthecontainerissealedonfusionorsealedtightlywithsuitablematerialtoprotectagainstcontaminationandfrompermeabilityofairandmoisture.

Coolplacereferstothatthestoragetemperatureisnotexceeding20℃.

Coolanddarkplacereferstothatthecontaineriskeptinthedarkplace,protectedfromlightandtheambienttemperatureisnotexceeding20℃.

Coldplacereferstothatthecontaineriskeptatambienttemperatureof2-10℃.

Normaltemperaturereferstothatthecontaineriskeptatambienttemperatureof10-30℃.

12.thedrugsubstancesandexcipientsusedinpreparationsordosageformsshouldcomplywiththerequirementsstatedintheindividualmonographsofthiseditionofPharmacopoeia:

forthosenotadmittedinthiseditionofPharmacopoeiatheirspecificationsshouldbeestablished,whichshouldcomplywithrequirementsforPharmaceuticaluseandbeapprovedbythedrugregulatoryauthorityoftheStateCouncil.Wherethesamedrugsubstanceisusedfordifferencepreparations,especial