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1、andlong-termstabilitytestsofthreebatchessampleswerecarriedonforsixmonths.Andthevalidperiodoftheproductwasconfirmedprimarily.Results:TheoptimumprocessofsupercriticalCO2extractionwasasfollows:extractingpressureat26MPa,extractingtemperatureat50℃,separatingpressureat7MPa,separa
2、tingtemperature30℃,extractingtimefor3hours,andthepulverizationincoarsepowder;Theoptimumprocessofwaterextractionwasasfollows:herbsindecoctionpieces,10timeswater,extracting3times,everytimeanhour;Thedecoctionwasconcentratedindecompression(vacuum-0.06~0.07Mpa)at70℃;Thebestalcoh
3、olprecipitationprocesswasasfollows:Thedecoctionwasconcentratedtoclearpastewithrelativedensity1.20(50℃),andthecontentofethanolwasupto60%(V/V),withprecipitatingtimeas12hours;Intheoptimizedspraydryingcondition,therelativedensityofthedecoctionwas1.20(50℃),theinflowwindtemperatu
4、rewas160℃,andtheoutflowwindtemperaturewas80℃;Intheformulationprocess,Thequantityoftheabsorbentmicropowdersilicagelwasdeterminedas10%(m/m),andthecriticalrelativehumidityofthegranuleswas56.7%;Inthequalitystandard,theTLCconditionhadagoodseparation,andthespotswasdistinct,andthe
5、negativecontrasthadnodisturbtothesample.TheresultsofexaminationwereaccordwiththepreparationgeneralruleinChinapharmacopoeia;Theresultsofmethodologytestofthecontentdeterminationwereaccordwiththedemandforquantitativeanalysis.Theaveragecontentinrepetitiontestwas9.946mg/g,RSD=1.
6、06%.Thequantitativeevaluationhadthelinearrangeof0.448~5.6mg.Theaveragerecoverywas96.86%andRSDwas1.17%;Theresultsofacceleratedandlong-termstabilitytestsshowedthatallindexesof3batchessampleshadnoobviouschangesduringtheregulativeperiod.IVConclusion:ThepreparationtechnologyofNa
7、omaitongcapsulewasreasonableandfeasible.Themethodsforidentificationandquantitationweresimple,specificandreproducible.ItcanbeusedeffectivelyforthequalitycontrolofNaomaitongCapsule.Thequalityoftheproductwasstable,anditsvalidperiodwasconfirmedas2yearstemporarily.Keywords:Naoma
8、itongcapsule;preparationtechnology;qualitystandard;Stability;salvianolicacidBV引言中风
