格列本脲緩釋片的研制.pdf

1、天津醫(yī)科大學(xué)碩士學(xué)位論文格列本脲緩釋片的研制姓名：項(xiàng)振玲申請(qǐng)學(xué)位級(jí)別：碩士專業(yè)：免疫學(xué)指導(dǎo)教師：姚智20090501天津醫(yī)科大學(xué)碩士學(xué)位論文Abstractobjeetive：ToscreentheoptimalizingformulaofextendedactiontabletofglibenclamideandestablishtheassaymethodofthedrugconcentrationinplasmaMethods：I

2、nthisPaDerthereleasingdegreeinvitroWasusedasindicatortoevaluatetheeffectsofHPMCviscosity，diluents，cohesivesandsquashpressureontheextendedactiontabletofglibenclamideHPMCwasselectedashydrophilicgelmatrix1actoseandethylcell

3、ulose(EC)asthediluents，and70％alcoholascohesivesTheprescriptionofextendedactiontabletofglibenclamideWasexcellentlyscreenedwithL9(3斗)orthogonaldesign，andthreeinfluencingfactorssuchasHPMC，ECandlactosewereselectedThelevelsof

4、HPMCwere40，50，and60mg；thelevelofEC10，20，and30mg；theleveloflactose80，100and120mg，respectivelyThereleasingrateofeachprescriptioninvitroWasdeterminedandanalyzedSOastochoosethebestResult：Thereleasingmechanismofsustained—rele

5、asetabletWasprimarilystudiedSeveraldrugreleasingmodelsweresimulatedandshowedthatthedrugreleasingcurveinvitroWasconsistentwithWeibullequationLnLn(1／(1F))11176Int18746(r；O9998)ThereleaseparameternobtainedfromRitgerPeppaseq

6、uationwas07549，between045and089，indicatingthatthereleasemechanismWasdiffusionaswellasmatrixerosion，whichaccordswithretardtabletsHi曲performanceliquidchromatography(HPLC)methodwasdevelopedtodeterminethereleasingdegreeinvit

7、roTheconcentrationofglibenclamideandAUCwerelinearovertherangeofO5txgmL叫～1299mL～A=99483C30851fFO9999)ThemeanabsoluterecoveriesoflOW，middleandhighconcentrationswere1002％、9983％、9970％TheinterdayRSDwere17％，14％，and11％：andthein

8、tra—dayRSDwere16％，13％，and10％，TIletwokindsofRSDwerebothlowerthan2％whichshowedthismethodWasaccurate，reliableandreproducibleHPLCmethodWasestablishedtodeterminetheconcentrationofglibenclamideinplasmaTheglibenclamideconcentra

9、tionhadagoodlinearcorrelationintherangeof3300ngmLqY=00229X00309(，=O9999)Thelowestdetectablelimitwas3ngmL～ThemeanabsoluterecoveriesoflOW，middleandhi出concentrationswere7084％，7100％and7441％Themethodrecoveryrateswere9623％，975

10、4％，and9547％；TheinterdayRSDwere29％，32％，and32％；andtheintradayRSDwere13％，26％and36％，ThetwokindsofRSDwerebothlowerthan5％Conclusion：Thispreparationprescriptionisreasonable，andthepreparationtechnologyisfeasibleThjsassaymethodis