PDF下载-缓释控释制剂的释药系统及其指导原则

2080,,,:/;;,,1997,10%15%190/1991;1995();1996;19971998,();19981995;1999/,1999/301990,2(,1995)2;199587,15/,,2000(USP24)45/200019954,19(),:,;;,11.1(Sustained-ReleasePreparations),,,,,24h3412,,1.2(Controlled-ReleasePreparations),,,,,24h3412,,,,,,(Chronopathology),/,,3(PulsedReleaseSystem),()()570102;;;2001,7(1):57601JournalofHainanMedicalCollege571.3(EntericCoatedPrepa2rations),,,pH6.8,pH7.88.0,/,/2,,,,(),,(),/,,(),,(,)(),,,,,FDASearle(VerapamilHydrochloride),,,(5h)(),,2(TerbutalineSulfate)3,,;,,,(),,,,2000:;,,,,,3.13.2,pH38,,(10%20%)3.3-,3(30%1,;50%2,;75%3,),,5873.43(6);,(6)3.53Mt=ktln(M-Mt)=-Kt+lnMHiguchiMt=ktMtt;M()(MSE)44.12(),;,4.2,FDA,,,,():;;,,AUC4,4.3,(),,CminCmax,;,()2000:,,;:AUC,AUC,,,,5,65,,5.1,37:():;:,():(t50%t90%)(AUC,Cmaxtmax),2000:,5.2,Wag-ner-Nelson,(Fa):Fa=(Ct+kAUC0t)/(kAUC0)Ctt,k121.59,Loo-Rigelman5.3(),,,,,(,),(P0.001),6/,(pulsedre2leasesystem)(intelligentdrugdeliverysystem),,(),,,(pH),pH,,,,,,1,..,1996,5(3):1741762,,,.1995.,1995,5(4):2022063,..,1999,23(5):2652694..(),1999,26(1):33365./,,1996,5(3):1671746..,1995,11(1):58627..,1995,19(3):140144(2000-04-12)607,,,,,,,,,22,32,19.00:33::[phone]:570102