溶出度研究系列文章-简介日本“薬品品質再評価”工程（溶出

·1200233(1)(2)(3)(4)(5)GMPGMP1998“”[1,2,3]860“”“”·2pHpH[4,5,6]15050%607070%11pH(dyne/cm2)(ml)1.2~7.635~505~200pH(mmHg)3.1~6.73~30pH(µmol/L)(ml/min)5.2~6.00~170~21·3?(1)pH=1.22.0g7ml1000ml0.1mol/L9ml1000ml(2)pH=4.00.05mol/L-0.05mol/L16.4:3.6685%pH(3)pH=6.83.4g3.55g1000ml(4)pH1.2pH6.81⎯⎯⎯→⎯ApH1.2pH6.8B2·4ApH6.8ABBAB1002100⎯⎯⎯→⎯50⎯⎯⎯→⎯350[7]100·5“”Orangebook4“”1·6900ml50pHpH4.0pH6.00.01mol/L0.005mol/L-800.01%0.1%0.5%1.0%510153045609012016153045609012034568101224pH1.2290%22.120~302.22.332.42.52.6pH2.03.05.02.7·72.83pH50900ml5:20mg4:20mgE112Y0150pH=4.0pKa:7.06pH1.24.06.829.0mg/ml15.7mg/ml2.8mg/ml1.9mg/mlpH1.22486.5%[8]f2[9,10]·8(Weibull)T50TdT80m[11]pKapHHenderson—Hassalbalch-abCCpKapHlg+=CbCapHpHpKapHpKapKa(pKa+pKb)/2pKa·94[12,13]4.14.24.310%~20%4.44.54.65TheIntroductionabouttheProjectionofDrugQuality’sRe-evaluationinJapanSeriesoneoftheDissolutionStudyXieMu-Feng(ShanghaiInstituteofDrugControl,Shanghai200233)ABSTRACTIntroducethehistorybackground,details,andinfectionoftheprojectionofdrugquality’sre-evaluation.Howtoestablishtherelationshipbetweendissolutioninvitroandbioavailabilityinvivohowtoadvancetheinternal-qualityof·10drug,howtoincreasethesuccess-probabilityofbioequivalence-testinJapanwasexpatiated.KeyWorddissolutionbioavailabilitybiologic-equivalenttestPharmacyJapan-Orangebookdrugquality’sre-evaluation200233100[14]·1150100pH=4.06.8f256445020051500.1mol/L1000ml6065%75900ml53060%70%·1274WS1-(X-066)-2003Z0.01mol/LpH4.5-(2:1)900ml503080%0.5%0.01mol/L50%pH7.0900ml503080%150(pH8.6)1000ml6018050%75%50pH6.0900ml54555%75%pH=1.26.8·138437pH1.26.06.8220g/ml153g/ml614g/ml44g/mlpHpH6.8pH8.6·14[15,16]7111516GMPGMP50100GMP[17]2007820120[18][19,20,21]·15[22]orangebook80%2004[23]GMP123456789·1610.[24]1[25]23456·17ImproveontheEvaluationMethodofDissolution,AdvancetheLevelofPharmacyHowtoadvancetheinternal-qualityoftheLocalOralpreparationSeriesTwooftheDissolutionStudyXieMu-Feng(ShanghaiInstituteofDrugControl,Shanghai200233)ABSTRACTExpatiatethedifferencebetweenthelocaldrugandImportdrugonOralpreparation.Theimprovementsandsomesuggestionsarealsopresented.KeyWorddissolutionbioavailabilitybiologic-equivalenttestPharmacy·181.[M].48791222.2.595107153.634107154.MoriharaM,AoyagiN,KaniwaN,etal.AssessmentofgastricacidityofJapanesesubjectsoverthelast15years.BiolPharmBull.2001Mar;24(3):313-5.5..,1993,24(10):1031~10416..[M].,1996.2177..3.2005,3(24):235-2368.orangebook9...,2000,35(2):13010..,2000,14(5):32632811..20056,6(24),520-521.12.().Homepage13.PHARMTECHJAPAN.200310(19):133(1769)-140(1776).14.----2005-7-715..[J]1991,11(5):209~2111.16...2004,2(20):150-152.17.BP2004-05-2617:2218.,200532919.,20052220.,200511129207.21.,200511129207.22.,,20041827205.·1923.[2004]3524.[2001]1325[e-mail]021-64703139-13313613764153662615200233