中药口崩片体外崩解时限测定方法的研究

84620097307:10.3724/SP.J.1008.2009.008461,1,1,2,131.,2004332.,200433[]:,:(),,:,;,,,,:(),[];;;[]R917.4[]A[]0258-879X(2009)07-0846-04DeterminationmethodforinvitrodisintegratingtimeoforaldisintegratingtabletsofChineseherbaldrugTONGYe1,DINGXue-ying1,GAOJing1,CAIZhen2,GAOShen131.DepartmentofPharmaceutics,SchoolofPharmacy,SecondMilitaryMedicalUniversity,Shanghai200433,China2.PharmacyDepartment,ChanghaiHospital,SecondMilitaryMedicalUniversity,Shanghai200433[]2009-01-15[]2009-03-02[],.E-mail:[e-mail]3(Correspondingauthor).Tel:[phone],E-mail:[e-mail][ABSTRACT]Objective:Todevelopmethodsfordeterminingthedisintegrationtimeoforaldisintegratingtablets(ODTs)ofChineseherbaldrug,andtoselecttheevaluationmethodwithgoodreproducibility,resolvingpower,andinvivoandinvitrocorrelation.Methods:SeveralplaceboODTsandChineseherbaldrugODTswereprepared.Theirinvitrodisintegrationtimewasdeterminedbyself-developedmethodandroutinemethods,andtheresultswerecomparedwiththeoraldisintegrationtime.Thereproducibility,resolvingpower,andthecorrelationbetweeninvivoandinvitroofthosemethodswereevaluated.Results:Differentdeterminationmethodsobtaineddifferentdisintegrationresultsofthesametablet.Graduatedcylinderandimproveddisintegrationapparatusbothhadshortcomingsandtheirdeterminationresultswereverydifferentfromthatoftheoraldisintegrationtime.Ourself-developeddisintegrationdevicecouldbetterdeterminethedisintegrationabilityoftheODTs,andtheresultwasclosertotheoraldisintegrationtime,withclearendpointofdisintegrationandbetterreproducibility,resolvingpower,andtheinvivoandinvitrocorrelationcomparedwithothermethods.Conclusion:Ourself-developeddeviceissuitabletodetermineinvitrodisintegrationtimeofODTs,andmayserveasareferenceforqualitycontrolofODTs.[KEYWORDS]Chineseherbaldrugs;orallydisintegratingtablets;disintegrationtime;analyticalchemistry(TCD)[AcadJSecMilMedUniv,2009,30(7):846-849](orallydisintegratingtablets,ODTs)(1min),ODTs,,[1-2]ODTs,,,ODTs[3][4-5][6][6][7]CCDCamera[8]TabAll[9],[10],,(),11.112(),7.,.847(A)(C)(),(B)(),(),(),ZP-130(),78X-3C(),RCZ-6C()1.21.2.1[10]1,30BA,C,37,D,E,,,,,,,1Fig1Self-developeddisintegrationdeviceforODTsA:Container;B:Screenmesh;C:Medium;D:ODTs;E:Rotaryshaft1.2.22ml10ml,37,,,30,,1.2.31000ml150ml,3730,,,2ml,1.31.3.1,,,,,,,,,,(16306080),16,,()710m6080,,,,30,,,,710m,301.3.2,,,,(10g15g)(135r/min),15g5r/min,,1r/min,,,,10g3r/min,,,,,,,,,,,1.41.4.1AB,60,,9mm,3kg,202mgA/B4z65z56z47z38z29z110z0,71.4.280,A/B(8z2)C,,,60,,12mm,3kg,300mg10%40%A/B,7,,17;10%34%C,7,,8141.51.5.16,2228,,,,,,,,,20min,84820097,301.5.23,622.1A/B2A/B8z29z1,,8z2A/B,A/B8z22.2A/B,60s,CA/BC,3,A/B30%C20%2Fig2DisintegrationtimeofplaceboODTsasdeterminedbyseveralmethodsandhumansensorytestn=6,xs3Fig3DisintegrationtimeofChineseherbaldrugODTsasdeterminedbyseveralmethodsandhumansensorytestn=6,xs2.323,2.44A4B4,(x1),3,,,2ml,,,(RSD8%),(),,,,,(RSD8%,RSD10%),()4(A)(B)Fig4Relationshipbetweendisintegrationtimeofplacebo(A)andChineseherbaldrug(B)ODTsasdeterminedbyourmethodandhumansensorytest7.,.849,,,,(RSD5%),(),,,,,,,,,,,,(),[][1],,,.[J].,2005,22:409-412.[2],,.[J].,2005,40:801-805.[3],,,.[J].,2007,16:926-929.[4]QueL,WuW,ChengXF,HuT.Evaluationofdisintegratingtimeofrapidlydisintegratingtabletsbyapaddlemethod[J].PharmDevTechnol,2006,11:295-301.[5]SunadaH,BiY.Preparation,evaluationandoptimizationofrap2idlydisintegratingtablets[J].PowderTechnol,2002,122:188-198.[6],,,,,.[J].,2007,42:276-279.[7]BattuSK,RepkaMA,MajumdarS,MadhusudanRY.Formu2lationandevaluationofrapidlydisintegratingfenoverinetab2lets:effectofsuperdisintegrants[J].DrugDevIndPharm,2007,33:1225-1232.[8]MoritaY,TsushimaY,YasuiM,TermozR,AjiokaJ,Takaya2maK.EvaluationofdisintegratingtimeofrapidlydisintegratingtabletsviaanovelmethodutilizingaCCDCamera[J].ChemPharmBull,2002,50:1181-1186.[9]ShibataY,YamamotoY,FujiiM,KondohM,WatanabeY.AnovelmethodforpredictingdisintegrationtimeinthemouthofrapidlydisintegratingtabletbycompactionanalysisusingTabAll[J].ChemPharmBull,2004,52:1394-1395.[10]NarazakiR,HaradaT,TakamiN,KatoY,OhwakiT.Anewmethodfordisintegrationstudiesofrapiddisintegratingtablet[J].ChemPharmBull,2004,52:704-707.[]2008,,2009956DavidI.Mostofsky,18,AmarendraN.Singh,,,8[:2009-03-10-106()],:,,,,,:2009815::010-83266840/67534765:010-67538381E-mail:[e-mail]();[e-mail]():2409:100068:,