PET放射性药物的质量保证和质量控制

doi:10.7538/tws.2001.14.Z1.0241

同位素 ›› 2001, Vol. 14 ›› Issue (Z1 ): 241-241 .DOI: 10.7538/tws.2001.14.Z1.0241

PET放射性药物的质量保证和质量控制

作者

@党淑琴$中国原子能科学研究院同位素研究所!北京102413 @夏振民$中国药品生物制品检定所!北京100050

收稿日期:2000-12-28 出版日期:2001-10-20 发布日期:2001-10-20

Quality Assurance and Quality Control of PET-radiopharmaceuticals

DANG Shu qin 1, XIA Zhen min 2 (1.Department of Isotope, China Institute of Atomic Energe, Beijing 102413, China; 2.National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China)

Received:2000-12-28 Online:2001-10-20 Published:2001-10-20

摘要/Abstract

摘要： 随着我国高能正电子断层显像技术应用的迅速开展 ,研制和开发符合标准的正电子药物应用于临床已是当务之急。由于正电子放射性药物寿命短 ,迫使人们必须建立质量控制的新概念。质量控制是强调法规控制下研制和生产过程的质量保证 ,最终产品的质量检验只作为此类药物质量证明的补充

关键词: PET放射性药物, 质量控制(QC), 药物研制管理规范(GLP和GCP), 药品生产管理规范(GMP/GRP), 质量保证(QA)

Abstract: It is an urgent matter to research and develop the PET radiopharmaceuticals, which is up to the national standard for clinical use keeping pace with the growth of application of PET in China. Time factor necessitates new concepts of quality control (QC) to be strength, which is the quality assurance (QA) under the regulatory control for this kind of radiopharmaceuticals, the action of the routine test for finished products is regarded as a complementary testimony of the quality.

Key words: radiopharmaceuticals for PETquality control (QC), good laboratory practice (GLP) and good clinical practice (GCP), good manufacture practice (GMP) or good radiopharmacy practice (GRP), quality assurance(QA)

中图分类号:

R951
R817

作者. PET放射性药物的质量保证和质量控制 [J]. 同位素, 2001, 14(Z1 ): 241-241 .

参考文献

[1]　EmranAM,NewTrends inRadio-pharmaceuticalSynthesis,QualityAssurance andRegulatoryControl[M].NewYork:PlemumPress,1991. [2]　周海钧,张瑞.当代新药研究与开发指南[M].北京:中国医药科技出版社,1997. [3]　Vera-ruizH,MarcusCS,PikeVW,etal.QualityControl ofCyclotron-producedRadiopharmaceuticals[C].IAEA,1990. [4]　PascalicC,BogniA,IwataR,etal.[11C]methylation on aC18Sep-PakCartridge:aConvenientWay toProduce[N-Methyl-11C]Choline[J].JLabelledCompdRadiopharm,2000,43:195～203. [5]　 deGrootT,BormansG,BussonR,etal.Synthesisof1-[18F]fluoro-deoxyglucoseandUnexpectedRearrangementintheReaction of2-o-methaneSulfonyl-β-D-mannopyranoseWith[18F]fluoride[J].JLabeledCompdRadiopharm,1999,42:147～157. [6]　赵贵植,尤卫忠,李大康,等.19F NMR方法验证无载体18FDG合成的异构选择性[J].同位素,1997,10(10):129～134. [7]　HyllbrantB,TyreforsN,MarkidesKE,etal.LC-radio-UV Coupled toMSforImprovedSensitivity andSelectivity inAnalysis ofPET-radiopharmacenticals[J].JLabeledCompdRadiopharm,1997,40:197～198. [8]　PascalicC,BogniA,IwataR,et al.HighEfficiencyPreparation ofL-[S-methyl-11C]methionine byOn-column[11C]methylation onC18Sep-Pak[J].JLabeled compdRadiopharm,1999,42:715～724. [9]　TheUnitedStatesPharmacopeia23/NF 18,1995,FludeoxyglucoesF-18Injection[S]. [10]　TheUnitedStatesPharmacopeia,23/NF18,1995,FluoredopaF-18Injection[S]. [11]　MonclusM,LaxenA,CoolV,et al.Synthesis of(R)-and(S)-9-{3[18F]fluoro-1-hydroxy-2-proposy}guanine:Radiopharmacenticals forGeneTherapy[J].JLabeledCompdRadiopharm,1997,40:20～22. [12]　TewsonTJ,StekhovaS.Synthesis of theStereoisomers of[18F]-fluoropropanol,aTracer for theβ-adrenergicReceptor[J].JLabeledCompdRadiopharm,1997,40:58～59. [13]　LambinD,LemaireC,PlaenevauxA,et al.Synthesis of aFluorinatedAnalogue ofL-threo-3(3,4-dihydro-zyphenyl) serine:6-Fluoro-L-Threo-Dops[J].JLabeledCompdRadiopharm,1997,40:13～18. [14]　VanDortME,TluczekL.11C-Labelling of theStereoisomers ofMeta-hydroxyephedrine(HED) andMeta-hydroxypseudoephedrine(HPED)[J].JLabeledCompdRadiopharm,2000,43:603～612

PET放射性药物的质量保证和质量控制

Quality Assurance and Quality Control of PET-radiopharmaceuticals

PDF

可视化

被引次数

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 0

编辑推荐

Metrics