NO5——“含量规格不同的口服固体制剂生物等效性试验指导原则”和

[e-mail][e-mail][e-mail]3D-3FDASUPAC-IRSUPAC-MRSUPAC-IR:ImmediateReleaseSolidOralDosageForms;Scale-UpandPostapprovalChanges:Chemistry,Manufacturing,andControls,InVitroDissolutionTesting,andInVivoBioequivalenceDocumentation,November,1995.199511SUPAC-MR:ModifiedReleaseSolidOralDosageForms;Scale-UpandPostapprovalChanges:Chemistry,Manufacturing,andControls;InVitroDissolutionTestingandInVivoBioequivalenceDocumentation,September1997.19979A10%(1)BCS*[e-mail]4BCSBPTTPWaiverofInVivoBioavailabilityandBioequivalenceStudiesforImmediateReleaseSolidOralDosageFormsContainingCertainActiveMoieties/ActiveIngredientsBasedonaBiopharmaceuticsClassificationSystem,August2000,FDA.20008FDA(2)SUPAC(3)[e-mail][e-mail]6-9A[e-mail][e-mail]8A-19A25%-20A-213A2*21CFR320.22(c)[e-mail]9-23AD-24A-25-25A(HPMC)[e-mail]102pH6.8-26EA-272ApH(AEA)[e-mail]11A-30A-31ASB0BWB0BDB0BSWD(S/SB0B)2/300/()/WDWDhB0Bh(h/hB0B)(wB0BdB0B)(wd)2/30000(/)/(/)[](/)/(/)wdwdWDWD(h/hB0B)2/300(/)[](/)@sina.com12-32A-33[e-mail]13-36pHpHApH-37A-38A-39pH6.0pH6.0pHApH6.0PTTP-40invivo-invivitro:[e-mail]14-41pHAPTTP-42-80A-40HPLC[e-mail][e-mail][e-mail]17AA-11UUA40mg(10.00%)P*1)P40mg(10.00%)40mg(10.00%)35mg(8.75%)K3020mg(5.000%)23mg(5.750%)4mg(1.000%)4mg(1.000%)100mg(25.00%)97mg(24.25%)196mg(49.00%)201mg(50.25%)400mg400mg*1)UU-1.25%(B)K300.75%(C)-0.75%1.25%2.00%(B)(1.25+0.75+2.00)4.00%(B)[e-mail]182UA40mg(10.00%)P*1)P40mg(9.52%)40mg(10.00%)45mg(10.71%)K3020mg(5.000%)23mg(5.476%)4mg(1.000%)4mg(0.952%)100mg(25.00%)108mg(25.71%)196mg(49.00%)200mg(47.62%)400mg420mg*1)A7.5mg(75.00%)P*2)P8.0mg(74.07%)P*2)PB2.5mg(25.00%)P*2)P2.8mg(25.93%)P*2)P10.0mg10.8mg2.51cmP2P2.56cmP2P3.98mg/cmP2P4.22mg/cmP2P(106.03%)P*3)P*2)*3)U0.71%(B)K300.476%(B)-0.048%(B)0.71%-1.38%2.09%(B)(0.71+0.48+0.05+2.09)3.33%(B)[e-mail]19A-0.93%B0.93%1.86%(B)6.03%(B)BB3UA10mg(8.33%)P*1)P10mg(8.33%)K303.6mg(3.00%)3.4mg(2.83%)0.4mg(0.333%)0.6mg(0.500%)86mg(71.67%)82mg(68.33%)12mg(10.00%)14mg(11.67%)8mg(6.67%)10mg(8.33%)120mg120mg*1)A1.17mg(13.30%)P*2)P1.2mg(13.48%)P*2)PB1.63mg(18.52%)P*2)P1.63mg(18.31%)P*2)PC6mg(68.18%)P*2)P6.07mg(68.20%)P*2)P8.8mg8.9mg1.495cmP2P1.495cmP2P5.89mg/cmP2P5.95mg/cmP2P(101.02%)P*3)P*2)*3)[e-mail]20D7.64mg(12.32%)P*2)P7.6mg(13.10%)P*2)PE4.4mg(7.03%)P*2)PF50mg(80.65%)P*2)P46mg(79.31%)P*2)P62mg58mg1.495cmP2P1.495cmP2P41.5mg/cmP2P38.8mg/cmP2P(93.49%)P*3)P*2)*3)UK30-0.17%(B)0.167%(B)-3.34%1.67%1.66%6.67%(C)(0.17+0.17+6.67)7.01%(C)A0.18%B-0.21%C0.02%0.41%(B)1.02%(B)[e-mail]21D0.78%E0.56%F-1.34%2.68%(B)-6.51%(B)CCA-21UUA40mg(13.33%)P*1)P80mg(17.02%)40mg(13.33%)60mg(12.77%)K3020mg(6.667%)30mg(6.383%)4mg(1.333%)6mg(1.277%)100mg(33.33%)135mg(28.72%)96mg(32.00%)159mg(33.83%)300mg470mg*1)UU-0.56%(B)K30-0.284%(B)-0.056%(B)-4.61%1.83%6.44%(C)[e-mail]22(0.56+0.28+0.06+6.44)7.34%(C)CC2UA40mg(13.33%)P*1)P80mg(17.02%)40mg(13.33%)60mg(12.77%)K3020mg(6.667%)30mg(6.383%)4mg(1.333%)6mg(1.277%)100mg(33.33%)135mg(28.72%)96mg(32.00%)159mg(33.83%)300mg470mg*1)A7.5mg(75.00%)P*2)P8.5mg(73.91%)P*2)PB2.5mg(25.00%)P*2)P3.0mg(26.09%)P*2)P10.0mg11.5mg2.12cmP2P2.76cmP2P4.72mg/cmP2P4.17mg/cmP2P(88.35%)P*3)P*2)*3)U-0.56%(B)K30-0.284%(B)-0.056%(B)[e-mail]231.83%6.44%(C)(0.56+0.28+0.06+6.44)7.34%(C)A-1.09%B1.09%2.18%(B)-11.65%(C)CC3UA40mg(13.33%)P*1)P80mg(17.02%)40mg(13.33%)60mg(12.77%)K3020mg(6.667%)30mg(6.383%)4mg(1.333%)6mg(1.277%)100mg(33.33%)135mg(28.72%)96mg(32.00%)159mg(33.83%)300mg470mg*1)A7.5mg(75.00%)P*2)P8.5mg(73.91%)P*2)[e-mail]24B2.5mg(25.00%)P*2)P3.0mg(26.09%)P*2)P10.0mg11.5mg2.12cmP2P2.76cmP2P4.72mg/cmP2P4.17mg/cmP2P(88.35%)P*3)P*2)*3)C11.5mg(12.37%)P*2)P13.0mg(11.71%)P*2)PD6.5mg(6.99%)P*2)P8.0mg(7.21%)P*2)PE75.0mg(80.65%)P*2)P90.0mg(81.08%)P*2)P93.0mg111.0mg2.12cmP2P2.76cmP2P43.9mg/cmP2P40.2mg/cmP2P(91.57%)P*3)P*2)*3)U-0.56%(B)K30-0.284%(B)-0.056%(B)-4.61%1.83%6.44%(C)(0.56+0.28+0.06+6.44)7.34%(C)A-1.09%B1.09%2.18%(B)[e-mail]25-11.65%(C)[e-mail]26C-0.66%D0.22%E0.43%1.31%(B)-8.43%(B)[e-mail]27B10%12(tBLB)-PTTP5%3-4-5(tBsiB)-6B-1B-21)-3)-(tBsiB)7(tBciB)(tBciB)85%85%B-185%121dBAB%tBAB112121()AAddttttdd−=+×−−[e-mail]28tB1BdBAB%tB2BdBAB%dB1BtB1BdB2BtB2B105101520253035404552.56067.57590(1)01.38.117.829.341.651.660.168.375.281.884.191.297.2100.0(2)00.88.920.931.842.252.059.166.372.981.388.993.796.798.5(3)01.811.323.735.045.855.762.270.377.382.888.191.094.197.2(4)01.67.416.126.436.544.955.565