中药指纹图谱的分类和发展-罗国安

tainingdoxorubicinPLGAconjugateforsustainedrelease[J].PharmRes,1999,161114-1118.[22]StormG,BelliotSO,DaemanT,etal.Surfacemodificationofnanoparticlestoopposeuptakenythemononuclearphagocytesystem[J].AdvdrugDelivRev,1995,1731-48.[23]KreuterJ.Nanoparticulatesystemsforbraindeliveryofdrugs[J].AdvDrugDelivRev,2001,4765-81.[24]NishiokaY,YoshinoH.Lymphatictargetingwithnanoparticulatesystem[J].AdvDrugDelivRev,2001,4755-64.[25]LambertG,FattalE,PintoAlphandaryH,etal.Polyisobutylcyanoacrylatenanocapsulescontaininganaqueoscoreasanovelcolloidalcarrierforthedeliveryofoligonucleotides[J].PharmRes,2000,17707-713.[26]DeJaeghereF,AllemannE,DoelkerE,etal.pHdependentdissolvingnanoandmicroparticelsforimprovedperoraldeliveryofahighlylipophiliccompoundindogs[J].PharmSci,2001,328-31.[27]HirofumiTakeuchi,HiromitsuYamamoto,YoshiakiKawashima.Mucoadhesivenanoparticulatesystemsforpeptidedrugdelivery[J].AdvDrugDelivRev,2001,4739-54.[28]LeongKW,MaoHQ,TruongLeVL,etal.DNApolycationnanospheresasnonviralgenedeliveryvehicles[J].JControlledRelease,1998,53183-193.[29]MaoHQ,RoyK,TroungLeVL,etal.ChitosanDNAnanoparticlesasgenecarriers:systhesis,characterizationandtransfectionefficiency[J].JControlledRelease,2001,70399-421.[30]ZebelaHP,JunghansaM,MaienscheinbV,etal.Enhancedantisenseefficacyofoligonucleotidesadsorbedtomonomethylaminoethyacrylatemethylmethacrylatecopolymernanoparticles[J].EurJPharmBiopharm,2000,49203-210.[31],.[J].,2000,2139-42.[32],,.[J].,2000,3518-20.[33],,,.A[J].,1999,34308-312.[34],,.A[J].,1999,34532-538.[35],,.[J].,2000,2957-58.[36],,.S180[J].(),2000,()288-289.[37],,,.[J].,2001,312-15.(收稿日期:2001-10-29),(清华大学药物研究所,北京100084)[]中药指纹图谱是中药现代化关键问题之一中药指纹图谱不仅是一种中药质量控制模式和技术,更是一种进行中药理论研究和新药开发的模式和方法中药指纹图谱应具有特征性,重现性和可操作性其发展应分为2个阶段:初级阶段和高级阶段初级阶段应解决指纹图谱的建立方法和相似度判定高级阶段应实现指纹图谱特征和药效相关性研究,即指纹图谱的生物等效性研究[]中药指纹图谱;分类;发展[]R28[]A[]1003-3734(2002)01-0046-06ClassificationandDevelopmentofTCMFingerprintLUOGuoan,WANGYiming(MedicinalInstituteofTsinghuaUniversity,Beijing100084,China)[Abstract]TheTCMfingerprintisoneofthestrategicsubjectsforTCMmodernization.ItisnotonlyamodeandtechniqueforTCMqualitycontrol,butalsoaresearchmodeandstrategyforTCMtheoriesandnewdrugsdevelopment.TheTCMfingerprintneedtohavestablecharacteristics,reproducibilityandoperability.ThedevelopmentofTCMfingerprintconsistsoftwostages:theprimarystageandthesuperiorstage.Thetargetoftheprimarystageistodevelopanstrategyforestablishingafingerprintandevaluatetheconformability.ThetargetofthesuperiorstageistostudythecorrelationbetweencharacteristicofTCMfingerprintandthepharmacodynamics,thatisaresearchonthebiologicalequivalenceofTCMfingerprint.46ChineseJournalofNewDrugs2002,Vol.11No.12002111[Keywords]TCM;classification;development,21WTO,,,(),,,,1996,,,1998[1],,GMP,GAP,2()1996~2000,,,,,,(973)GMP,GAP,(),,,,,2,(SDA)[2],,,SDA:,,,,,,[3]1(fingerprint),,,,()(),(absoluteuniqueness)(individuality),DNA,DNA,,,,2:,DNADNA;,,(),,DNA1.1(fingerprinting)DNA,(HPLC)HPLC,,HPLC33,,DNA:(),,(),,,33()30,47ChineseJournalofNewDrugs2002,Vol.11No.1200211124%6%(),,()[7]1.2()1.2.1,,()(),()DNADNADNA,,DNAGAP(SOP)()(),,,,(similarity),,525,,,GAP,,,(),,,,(),,,1.2.2()()(IR)(TLC)(GC)(HPLC)(CE)[(MS)(NMR)][6,8,9,15]TLC,,GCHPLC,HPLCCE,,,GC/MS,HPLC/MS,HPLC/MS/MS,,,,HPLCDNA,,2,,HPLC22:,()()2.148ChineseJournalofNewDrugs2002,Vol.11No.12002111,,?,?2,,200,2090,,,,,,2.2,,,(),,(),(),,,,,[4,5,10],,(),,,,,GC/MSHPLC/DAD/MS/MS,,,,,2.3,,,,,,,,,,,(),,,,,,,,2,,,,,,,(),,;GAP,,,,,,,,,49ChineseJournalofNewDrugs2002,Vol.11No.12002111,,,,,()()(),,,61,,16,2,,,,,,,,,,,,,,,,2.42.4.1,(),,,,,,,()(/),,,,(),,,,,,,,,,,,2.4.2,,,,[12]1,5,,,301,,HPLC,22,,,313(),,,[7],,,(),,()50ChineseJournalofNewDrugs2002,Vol.11No.12002111(),,(),HPLC,(),(),,,2.4.3,,,,,(HPLC/PDAD/MS/MS),,,,,,[]罗国安(1946-),男,教授主要从事药物分析及新药开发方面的工作联系电话:[phone][][1],,.[M].:,1998.[2].()[J].,2000,22(10)671.[3].[A].[C]..2001.1-5.[4],.[J].,1997,19(8)44.[5],.[J].,1999,1(1)16.[6].()[J].,2001,22(6)391.[7],,.[J].,2000,22(6)395.[8].[J].,2001,3(1)35.[9],,,(),20008.[10],.[J].,1999,1(1)11.[11],,,[J].,1999,11208.[12],,,.[A].[C]()..2001.128.[13],,,.[J].,2001,3(4)20.[14],,,.[A].()[C],.2001.139.[15].[J].,2001,3(3)18.(收稿日期:2001-10-29)(ICH5),(上海医药工业研究院国家上海新药安全评价研究中心,上海201203)[]新药;药理毒理;国际申报要求[]R951[]A[]1003-3734(2002)01-0051-051()2,302.1,,51ChineseJournalofNewDrugs2002,Vol.11No.12002111