抗急性白血病创新药物sx004的药剂学处方前分析-pharmaceutical pre-prescription analysis of sx 004, an innovative anti-acute leukemia drug.docx

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2018-05-29 发布于上海
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抗急性白血病创新药物sx004的药剂学处方前分析-pharmaceutical pre-prescription analysis of sx 004, an innovative anti-acute leukemia drug.docx

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抗急性白血病创新药物sx004的药剂学处方前分析-pharmaceutical pre-prescription analysis of sx 004, an innovative anti-acute leukemia drug

PBSwithdifferentpHvaluewasinvestigated.TheresultssuggestedthatthesolubilityofSX004decreasedwiththepHvalueincreasing.Inthefourthchapter,thedissociationconstantofSX004wasassayedthroughthenonlogarithmictitrationmethodusingdifferentmethanol-watersolventsand0.01mol?L-1HCltitrationsolution.ThepKbwascalculatedaccordingtotheBenetmethod.TheresultsshowedthatthepKbofSX004was7.743.Theoil-waterpartitioncoefficient(logP)ofSX004wasdeterminedinthefifthchapter.Ashakingflask-HPLCmethodwasusedtodeterminetheconcentrationofSX004intheaqueousphaseafterthepartitionequilibriumofSX004inthen-octylalcohol-watersystem.Then,theoil-waterpartitioncoefficientofSX004wascalculated.TheresultsshowedthatthelgPalmostunchangedwhenthepHvalueofaqueousphasewasbelow6.0andabove7.0.SX004mainlyexistedintheaqueousphasewhenthepHvalueofaqueousphasewasbelow6.0,andintheoilphasewhenthepHvaluewasabove7.0.ThelogPofSX004increasedwiththepHvalueofaqueousphaseincreasinginarangefrom6.0to7.0.Inthesixthchapter,thehygroscopicityofSX004wasdeterminedat25℃indifferentrelativehumidity(33.0%,43.2%,57.7%,75.3%,84.3%,93.6%).Thehygroscopicityequilibriumcurvewasplotted,andtheCRHwascalculatedsubsequently.TheresultsshowedthattheCRHofSX004was63.33%,anditwasveryhygroscopic.Intheseventhchapter,wescreenedtheexcipientshavingnoinfluenceonthestabilityofSX004,anddesignedthefinallyformulation.TheratioofSX004toexcipientwaschosenaccordingtothetypeofexcipients.Inthedrug-excipientcompatibilitytest,thecontentandrelatedsubstanceofSX004weredeterminedbyHPLCafterstoragefor30daysat40℃and75%relativehumidity.Theresultsshowedthattheexcipients,whichwerecompatiblewithSX004,includedmicrocrystallinecellulose,low-substitutedhydroxypropylcellulose,carboxymethylcellulose,andfrenchchalk.Intheeighthchapter,thestabilityofSX004wasevaluatedthroughinfluentialfactorstest.TheresultssuggestedthatSX004wasverysensitivetohighlyrelativehumidity.Therefore,SX004waspackedandmonitoredina3-monthacceleratedtestat40℃and75%relativehumidity.Theresultsdemonstratedthattherewerenosignificantd