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他克莫司及其胶囊剂、软膏剂的质量研究 Introduction Tacrolimus,alsoknownasFK506orFujimycin,isamacrolideantibioticthatpossessesstrongimmunosuppressiveactivity.TacrolimusworksbyinhibitingtheproliferationofT-lymphocytesandpreventingtheiractivation,resultinginthesuppressionoftheimmuneresponseinorgantransplantpatients.Itiswidelyusedasanimmunosuppressantinsolidorgantransplantation,suchasheart,liver,andkidneytransplants,aswellasinthetreatmentofautoimmunediseases,suchaspsoriasis,atopicdermatitis,andrheumatoidarthritis. Tacrolimusisavailableindifferentdosageforms,includingcapsulesandointments.Thequalityofthesedosageformsiscriticaltoensuretheireffectivenessandsafety.Theobjectiveofthispaperistoreviewthequalityoftacrolimusanditsdosageforms,includingcapsulesandointments,andthefactorsthataffecttheirquality. QualityofTacrolimus Tacrolimusisahighlypotentdrug,anditsqualityiscriticalinensuringitsefficacyandsafety.Thefactorsthataffectthequalityoftacrolimusincludeitspurity,stability,andbioavailability. Purity Thepurityoftacrolimusiscriticalinensuringitseffectivenessandsafety.Thepurityoftacrolimusisdeterminedbyitschemicalstructure,whichcanbeanalyzedusingvariousanalyticaltechniques,suchasgaschromatography,high-performanceliquidchromatography,andmassspectrometry. Stability Thestabilityoftacrolimusiscriticalinensuringtheconsistencyofitspotencyovertime.Thestabilityoftacrolimusisaffectedbyvariousfactors,suchastemperature,moisture,andlight.Tacrolimusisstableinitssolidstatebutcandegradeovertimewhenexposedtomoistureorlight.Therefore,itisrecommendedtostoretacrolimusinacoolanddryplaceandavoidexposuretolight. Bioavailability Thebioavailabilityoftacrolimusisthedegreetowhichitisabsorbedandavailabletoexertitspharmacologicaleffects.Thebioavailabilityoftacrolimuscanbeaffectedbyvariousfactors,suchasfood,pH,andformulation.Forinstance,thebioavailabilityoftacrolimusishigherwhentakenonanemptystomachcomparedtowhentakenwithfood. QualityofTacrolimusCapsules Tacrolimuscapsulesarethemostcommondosageformusedforsolidorgantransplantpa