6厂家吲哚美辛肠溶片体外溶出试验比较

[]2004-03-25[],233004[](1963-),,,.[]1000-2200(2004)05-0467-02·检验医学·6,　,[]目的:6。方法:,,,,。结果:6(0.1mol/L),pH6.8。结论:6。[];;;;[]R927;R971.1　　　[]AComparisonofinvitrodissolutionresultsoftheenteric-coaledtabletsofindometacinfrom6pharmaceuticalfactoriesXUShan-chu,XINGRong,SHIQing-ping(DepartmentofPharmacy,AffiliatedHospitalofBengbuMedicalCollege,Anhui233004,China)[Abstract]Objective:Toinvestigatetheinvitrodissolutionresultsofenteric-coaledtabletsofindometacinprobidedby6differentdrugmanufacturers.Methods:Thedissolutiontestswerecarriedoutwiththerotatingbasket.Theultravioletspectrometricassaywasusedtodeterminetheconcentrationofindometacinindissolutionmedia.ThecumulativedissolutionpercentofthelabeledamountwascalculatedandtheWeibull'sequationwasusedtomodelthemaindissolutionparametersaccordingtothedissolutiondata.Thedifferencesbetweendifferentgroupswerestatisticallyanalysed.Results:Thedissolutiondataoftheindometacintabletsproducedbydifferentmanufacturersmeettherequirementsofpharmacopoeiainthedissolutiontestwithacidicmedium(0.1mol/LHCL),butonekindofindometacintabletfailedtomeettherequirementsofpharmacopoeiainthedissolutiontestwithpH6.8phosphatebuffersolution.Conclusions:Thedissolutionparametersoftheenteric-coatedtabletsofindometacinfrom6differentmanifacturesdiffergreatly.[Keywords]drugevaluation;indometacin;invitrodissolution;testwithrotatingbasket;enteric-coatedtablet　　,,,。,,,。6,,。1　1.1　药品与试剂　:A(:020210),B(:020107),C(:020508),D(:021015),E(:020121B),F(:020709),25mg。(,:20000212);(,:940203);(,:,ISE。,,,,。[][1]　KentL.ClinicalChemistry[M].Philadelphia:Lippincott,Williams&Wilkins,2002:641.[2]　BerryMN,MazzachiRD,PejakovicM,etal.Enzymaticdeterminationofpotassiuminserum[J].ClinChem,1989,35(5):817～820.[3]　HǜblW,WejbornR,Shafti-KeramatI,etal.Enzymaticdetermi-nationofsodium,potassium,andchlorideinabnormal(hemolyzed,icteric,lipemic,paraproteinemic,oruremic)serumsamplescomparedwithindirectdeterminationwithion-selectiveelectrodes[J].ClinChem,1994,40(8):1528～1531.[4]　CreerMH,LadensonJ.Analyticerrorduetolipemia[J].LabMed,1983,14(2):351～355.[5]　KrollMH,ElinRJ.Interferencewithclinicallaboratoryanalyses[J].ClinChem,1994,40(11):1996～2005.467蚌埠医学院学报2004年9月第29卷第5期DOI:10.13898/j.cnki.issn.1000-2200.2004.05.04920010526)。1.2　仪器　ZRS-4(),Du-640(),FA1604()。1.3　含量测定　《》(2000),690.07%、97.18%、94.72%、96.35%、94.08%、93.28%。1.4　溶出度试验　《》(2000)[1],6,,100r/min,(37±0.5℃),1000ml0.1mol/L,2h,,(pH6.8±0.05)1000ml,,45min,5、10、15、25、3545min,(),,,320nm,(A),,6。1.5　数据处理　{:lnln[1/(1-Y)]=mlnt-lnt0},m()、T50(50%)、Td(63.2%)。6m、T50、Td[2]。2　2.1　吲哚美辛肠溶片在酸性介质中的溶出结果　(0.1mol/L),6,。2.2　吲哚美辛肠溶片在磷酸盐缓冲液中的溶出结果　62h,5pH6.8,1,1。6m、T50、Td,6(2)。3　　1　(%)(ni=6;x±s)(min)510203045A8.17±1.6120.23±1.2148.25±1.6957.11±1.3674.58±1.91B6.21±0.4124.53±3.6940.17±2.2556.61±1.1078.09±2.52C11.95±1.5621.44±1.0944.25±2.0451.12±1.6476.00±3.15D19.33±0.7456.01±1.3666.72±1.7470.28±1.6680.26±1.23E10.34±0.6024.52±0.7257.04±1.3464.13±1.0278.23±1.25F2.95±0.377.34±1.1628.62±1.8543.19±1.5858.46±2.472　(ni=6;x±s)mT50TdA1.47±0.2420.44±2.9337.09±2.68B1.62±0.6822.17±4.8440.63±6.64C1.70±0.7223.41±4.3642.76±5.70D0.56±0.397.71±0.9314.13±1.37E1.31±0.2818.04±3.8433.06±7.21F2.50±0.1134.42±5.4363.08±3.30F11.0827.9460.71P0.010.010.01MS0.21416.01924.752　　“”,30%～50%,10%～20%。,[3][4]。6,,F。,,。,、,。[][1]　.中华人民共和国药典(二部)[M].:,2000:296,75.[2]　,.数理统计方法[M].:,1984:98.[3]　,,.[J].中国药科大学学报,2002,33(5):383～387.[4]　,,,.[J].第二军医大学学报,1999,20(1):52～54.468JBengbuMedColl,September2004,Vol.29,No.5