盐酸纳美芬注射液药代动力学

盐酸纳美芬注射液药代动力学

ID:32731525

大小:1.85 MB

页数:66页

时间:2019-02-15

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1、重庆医科大学硕士研究生学位论文2l0healthyvolunteerswereintravenousinjectiongiven0.5mg,lmg,2mgNalmefenehydrochlorideforsingledoseinsuccession.TheplasmaandurinesamplewereCollectedaccordingtoprogrammedschedule.Theelectrosprayionizationpositiveselectedreactionmonitoringdetec

2、tionsforNalmefenehydrochlorideandallyln—oroxymorphone(theinternalstandard)intheplasmaandintheurinewereused.thepharmacokineticparametersanddependabilityofdeferencedosewerecalculatedby3P87SOftware.Andthesametimetheadversewererecorded.Result:1REVEXandNLXwasw

3、ellseparatedandtherewasnosignificantinterferentialpeak.themethodexhibitedagoodlinearityinO.04to625ng/mlofREVEXwiththelowestdetectionlimitof0.0008ng/mlinplasma.Thedeviationofrecoveryratiowasfoundintherangeof92.50%---.108.40%.andthestandardcurvewasY=0.0148x

4、+O.0055,r--0.9990,n211.BothRSDbetweendaysandwithindaywerealllowerthanl0%.Meanwhileintheurinesamples,agoodlinearityintherange0.2to625ng/mlandthelowestdetectionlimitof0.0003ng/m1.ThelimitofthedetectionforNalmefenehydrochloridewasO.0003ng/mlinurine.thestanda

5、rdcurvewascalculatedtobeY=O.0514x-0.0059,r=O.9999,n=9.Thedeviationofrecoveryratio90.OO%~108.40%.BothRSDbetweendaysandwithindaywerealllowerthan10%.TheseresultsshowedthemethodestablishedinthestudyisspecificfordeterminationofREVEXandcouldbeusedinresearchingd

6、rugpharmacokinetics.2ThepharmacokineticsofREVEXwerefittedinatwo—compartmentopenmodelfollowingintravenousadministrationsingledoseof0.5mg、lmg、2mgofNalmefenehydrochloride.theobtainedpharmacokineticparameterswereasfollowsrespectively:Cmaxwere(1.74+0.48)ug/L,(

7、4.16重庆医科大学硕士研究生学位论文7+1.08)ug/L,(7.88+2.89)ug/L;h/213were(12.83+3.98)h,(12.6+6.4)h,(10.58士3.74)h;Vwere(3.45士0.16)L/kg,(4.11+0.0716)(L/kg)、(4.25士0.56)L/kg:CLwere(O.81+0.11)L/hr/kg,(O.85土O.15)L/hr/kg,(O.87+0.11)L/hr/kg;AUCo.∞were(21.62+9.34)(ng/L)宰h,(24.8918

8、.52)ngm)木h,(35+11.2)ng/L)%;therewasasignificantcorrelationwasobservedbetweenthemeanpeakconcentrationandAUCo.∞.within48h,afteranintravenousadministrationsingledoseof0.5mg、lmg、2mgofNalmefenehydrochloride.theurineaccum

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