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释药系统(drug delivery system,DDS) 中国药典(Chinese Pharmacopoeia,ChP) 美国药典(The United States Pharmacopoeia,USP) 美国国家处方集(The National Formulary,NF) 英国药典(British Pharmacopoeia,BP) 欧洲药典(European Pharmacopoeia,Ph.Eup) 国际药典(The International Pharmacopoeia,Ph.Int) 良好药品实验研究规范(Good Laboratory Practice,GLP) 良好药品生产规范(Good Manufacture Practice,GMP) 良好药品供应规范(Good Supply Practice,GSP) 良好药品临床试验规范(Good Clinical Practice,GCP) 分析质量管理(Analytical Quality Control,AQC) 药物的鉴别试验identification test 一般鉴别试验general identification test 专属鉴别试验specific identification test 灵敏度sensitivity 最低检出量minimum detectable quantity 最低检出浓度minimum detectable concentration 第2章 药物的杂质检查 巯基醋酸mercaptoacetic acid 古蔡Gutzeit 二乙基二硫代氨基甲酸银siliver diethyldithio-carbamate 硫酸灰分sulphated ash 炽灼残渣residue on ignition 热重分析法thermogravimetric analysis,TGA 差示热分析法differential thermal analysis,DTA 差示扫描量热法differential scanning calorimetry,DSC 碱性酒石酸铜试验Fehling’s reagent 异红紫酸盐isopurpurate 2,3-二氨基萘2,3-diaminonaphthalene 4,5-苯并苯硒二唑4,5-benzopiazselenol 汞齐化法amalgamation method 氧瓶燃烧法oxygen flask combustion method 葡萄糖醛酸甙glucuronides 硫酸酯sulphates 血浆plasma 血清serum 全血whole blood 治疗药物浓度监测therapeutic drug monitoring,TDM 结合bound 游离free 缀合物conjugate 液-液提取法liquid-liquid extraction,LLE 离子对试剂ion pair reagent 离子对提取法ion pair extraction method 反离子counter 液-固提取法liquid-solid extraction LSE 半自动样品制备系统advanced automated sample processor,AASP 烷基化alkylations 酰基化acylations 硅烷化silylations 精密度precision 标准差standard deviation,SD orS 相对标准差relative standard deviation,RSD 变异系数coefficient of variation,CV 批内精密度within-run precision 日内精密度within-day precision 批间精密度between-run precision 日间精密度day to day precision 准确度accuracy 定量限limit of quantitation,LOQ 检测限limit of detection,LOD 选择性selectivity 专属性specificity 线性与范围linearity and range 重现性ruggedness 耐用性robustness 散布图scatter diagram 荧光偏振免疫测定法fluorescence polarization immunoassay,FPIA 溴化十六烷基三甲基苄铵cetyltrimethylbenzylammonium bromide,CTMA 氯化四癸基二甲基苄铵Tetradacyldimethybenzylammonium chloride,TDBA 苯甲酸及其钠盐benzoic acid and sodium benzoate 布美他尼bumetanide 羟苯乙酯ethylparoben 丙磺舒probenecid 酚黄乙胺etamsylate 二硝基氯苯反应Vongerichten反应 戊烯二醛反应K?nig反应 生物碱alkaloids 阿片gum opium 扫尾剂tailing-suppressing reagent 蒂巴因thebaine 诺司卡品noscapine 竞争离子competing ions 亲脂性lipophicity
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