中英文对照术语表.docx

1、中英文对照术语表中英文对照术语表(ICH 质量)英文中文abbreviated or abridged aplication简略申请abnormal karyology异常核形absorbed moisture吸附水acceptable daily intake可接受的日摄入量acceptable test加速试验acceptance criteria认可标准accuracy准确性acelerated/stress stability Studies加速/强力破坏稳定性研究acetylation乙酰化作用achiral assay非手性测定achlorhydric elderly老年性胃酸缺乏

2、症action limits内控限值active components/comcound/moiety活性成分active ingredient活性组分adaption to specific culture conditions特定培养条件的适应additives添加剂adjuvant佐剂adventitious agents外源性因子adventitious contaminants外来污染物adventitious viral or mycoplasma contamination外源性病毒或支原体污染adventitious viruses外源病毒adverse reaction不良反

3、应aerobic microorganisms需氧微生物affinity亲和力affinity chromatography亲和层析affinity column亲和柱agar and broth琼脂和肉汤aggregates聚合体aggregation聚集allergenic/allergic extracts过敏原抽提物altered conjugated forms改变的结合物形式ambient condition自然条件amino acid composition氨基酸组成amino acid sequence氨基酸顺序amino acids氨基酸amino sugars氨基糖amin

4、o-terminal amino acids氨基端氨基酸ammonia production Rates产氨率analyte被测物analytical procedure分析方法animal cell lines动物细胞系animal tissues or organs动物组织或器官antennary profile触角形状antibiotic resistance genes抗生素耐药基因antibiotics抗生素antibody抗体antibody production tests抗体产生试验antisera抗血清applicant申报者ascites腹水assay含量测定assay p

5、rocedure定量方法avian鸟类avidity亲和性background背景bacteria细菌batches批次batch-to-batch逐批between-assay variation试验间变异binary fission双数分裂binding assays结合试验bioburden生长量生物负荷biochemical methods生化方法bioequivalency生物等效性biohazard information生物有害信息biological activity生物活性biological products生物制品bioreactor生物反应器biotechnologic

6、al/biological products生物技术生物制品biotechnological products生物技术产品biphasic curve双相曲线blood plasma factors血浆因子body fluids体液bovine牛bovine spongiform encephalopathy (BSE)疯牛病bracketing括号法breeding conditions饲养条件by-products副产物calibrate标化canine犬cap liner瓶帽内垫capillary electrophoresis毛细管电泳carbohydrate碳水化合物carboxy-

7、terminal amino acids羧基端氨基酸carrier载体/担体catalysts催化剂cell bank细胞库cell bank system细胞库系统cell banking procedures细胞建库过程cell banking system细胞库系统cell culture-derived impurities来源于细胞培养基的杂质cell cultures细胞培养物cell expansion细胞扩增cell lines细胞系cell metabolites细胞代谢物cell pooling细胞混合cell substrate-derived impurities来源于

8、细胞基质的杂质cell substrates细胞基质cell viability细胞活力cell-derived biological products细胞来源的生物制品cell fusion细胞融合cellular blood components血细胞成分cemadsorbing viruses红细胞吸附病毒characterization and testing of cell banks细胞库鉴定及检测charcoal活性炭charge电荷chemical actinometric system化学光化线强度系统chemical reactivity化学反应性chemical synt

9、heses化学合成chemically inert化学惰性chewable tablets咀嚼片chiral impurities手性杂质chromatograms色谱图chromatographic behavior色谱行为chromatographic procedures色谱方法chromatography columns色谱分离柱circular dichroism圆二色性clearance studies清除研究climatic zones气候带clinical research临床研究clinical trial application临床试验申请cloning克隆，closure

10、闭塞物code number编号coding sequence编码序列coefficient of variance变异系数collaborative studies协作实验研究colony isolation菌落分离colony-stimulating factors集落刺激因子combination product复方制剂Components成分confidence interval置信区间confidence limits可信限confirmatory studies确认研究conformance to specifications符合规范conformation构型conjugated

11、 product连接产物conjugation连接consistency一致性container容器container/closure容器闭塞物container/closure integrity testing容器密封完整性试验contaminants污染物contaminated cell substrate污染的细胞基质content uniformity含量均匀度control methodology控制方法学controlled released product控释制剂conventional vaccines传统疫苗conventional live virus vaccines

12、传统的活病毒疫苗conventional vaccines传统疫苗cool white fluorescent冷白荧光灯correction factor校正因子correlation coefficient相关系数covalent or noncovalent共价或非共价creams霜剂cross-contamination交叉污染cross-reactivity交叉反应cryopreservation冷冻保存cryoprotectants防冻剂crystals晶体culture components培养基成分culture media/medium培养基cyanogen bromide溴化

13、氰cytogenetic细胞遗传学的cytokines细胞因子cytopathic细胞病的cytoplasmic A-and R-type particles细胞浆a型和r型颗粒dark control暗度控制deamidation去氨基deaminated去酰胺化的deamination脱氨基decision flow chart/tree判断图definable and measurable biological activity明确和可测定的生物学活性degradant降解产物degradation降解degradation pathway降解途径degradation product降

14、解产物degradation profile降解概况degree of aggregation凝集度degree of scatter离散程度delayed-release延迟释放deleterious有害的delivery systems给药体系derivatives衍生物description性状detection limit检测限度dilivery systems释放系统dilution ratio稀释倍数dimers二聚体diode array二极管阵列diploid cells二倍体细胞dissociation解离dissolution testing溶出试验dissolution

15、time溶出时间dosage form剂型downstream purification下游纯化drug product制剂drug product components制剂组方drug substances原料药ectromelia virus脱脚病病毒elastomeric closures橡皮塞electron microscopy (EM)电镜electrophoresis电泳electrophoretic pattern电泳图谱elution profile洗脱方案embryonated eggs鸡胚enantiomer对映体enantiomeric镜像异构体enantioselec

16、tive对映体选择性encephalomyocarditis virus (EMC)脑心肌炎病毒endogenous agents内源性因子endogenous retrovirus内源性逆转录病毒endotoxins内毒素end-product sterility testing最终产品的无菌试验enhancers增强子enveloped RNA viruses包膜RNA病毒environmental factors环境因素enzymatic reaction rates酶反应速率enzyme酶epitope表位Epstein-Barr virus (EBV)EB病毒equine马eryth

17、ropoietins促红细胞生成素ethnic origin种族起源eukaryotic cell真核细胞ex vivo体外excipient赋形剂excipient specifications赋形剂规范expiration date/dating失效日期exposure level暴霹程度exposure period光照时间expression constract表达构建体expression system表达系统expression vector表达载体extended-release延时释放extent of the virus test病毒测试的程度extinction coeff

18、icient消光系数extrachromosomal染色体外extraneous contaminants外源性污染物extrapolation外推法fermentation发酵fermentation products发酵产品fill volume装量filter aids过滤介质final manufacturing最终生产finished product成品flanking region侧翼区forced degradation testing强制降解试验foreign matter异质性物质formal labeling正式标签formal stability studies正式的稳定

19、性研究formulation处方配方fragmentation片段化freeze-dried product冻干产品friability脆碎度fungi真菌fusion partners融合伴侣fusion protein融合蛋白gel filtration凝胶过滤gene amplification基因扩增gene therapy基因疗法generation of the cell substrate细胞基质的产生genetic manipulation基因操作genomic dinucleotide repeats基因组双核苷酸重复数genomic DNA基因组DNAgenomic pol

20、ymorphism pattern基因组形态类型genotypic基因型glucose consumption rates耗糖率glycoforms糖化形式glycosylation糖基化goegrapgical origin地理起源growth factors生长因子growth hormones生长激素guanidine胍hamster antibody production (HAP) test仓鼠抗体产生实验Hantaan virus汉坦病毒hardness硬度heavy metals重金属heparins肝素herbal products草药herpes virus疱疹病毒heter

21、ogeneities异质性heterohybrid cell lines异种杂交细胞系high-resolution chromatography高分辨色谱homogeneity均一性host cell宿主细胞host cell banks宿主细胞库host cell DNA宿主细胞DNAhost cell proteins宿主细胞蛋白质hot-stage microscopy热阶显微镜human cell lines人细胞系human diploid fibroblasts人二倍体成纤维细胞human polio virus人脊髓灰质炎病毒human tropism人向性humidity湿度

22、humidity-protecting containers防湿容器hybridization techniques杂交技术hybridoma cell杂交瘤细胞hybridomas杂交瘤hydrolysates水解物hydrolytic enzymes水解酶hydrophobicity疏水性hygroscopic吸湿性identification/identity鉴别immediate container/closure直接接触的容器/密闭物immediate pack内包装immediate release立即释放immortalization激活immune spleen cells免疫

23、脾细胞immunoassay免疫检测immunochemical methods免疫化学方法immunochemical properties免疫化学性质immunoelectrophoresis免疫电泳immunogenicity免疫原性immunological interations免疫相互作用immunoreactivity免疫反应性impurity profile杂质概况in vitro/in vivo correlation体内体外相关性in vitro and in vivo inoculation tests体内和体外接种试验in vitro assay体外检测in vitro

24、 cell age体外细胞传代期in vitro lifespan体外生命周期in vitro tests体外试验in vivo体内in vivo assays体内检测inactivated vaccine灭活疫苗indentification test鉴别试验indicator cell指示细胞indicator organisms指示菌indoor indirect daylight室内间接日光inducers诱导剂infectious agents感染性因子influenza virus流感病毒inhalation dosage forms吸入剂型in-house内部的in-house

25、criteria内控标准in-house primary reference material内部一级参比物质in-house reference materials内部参比物质in-house working reference material内部工作参比物质initial filing原始文件initial submission最初申报initial text最初文本inoculation接种inorganic impurities无机杂质inorganic impurities无机矿物质inorganic salts无机盐in-process acceptance criteria生产

26、过程认可标准in-process controls生产过程中控制in-process testing生产过程中检测insect昆虫insulins胰岛素intake摄入intended effect预期效果intended storage period预期的贮藏期intentional degradation人为降解interactions相互作用interferon干扰素interleukins白细胞介素intermediate中间体intermediate precision中间精密度intermediates半成品international reference standards国际参比

27、标准品intra-assay precision间隙含量精密度intracytoplasmic细胞浆内introduction of virus病毒介入inverted or horizontal position倒立或水平位置ion-exchange离子交换ionic content离子含量isoelectric focusing/isoelectrofocusing等电聚焦isoenzyme analysis同工酶分析isoform pattern异构体类型isomerized异构化的JpPhEurUsp日本药局方欧洲药典美国药典K virusK病毒karyology胞核学laboratory scale实验室规模lactate production rates乳糖产生速率lactic dehydrogenase virus(LDM)乳酸脱氢酶病毒leachables沥出物ligand配位体配体light光照light resistant packaging避光包装limit for in vitro cell age细胞体外传代限度limit of acceptance可接受的限度lim