药物分析期末复习资料
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精品文档 可编辑 药分期末复习（仅供参考） 题型及分值 一，写出英文缩写的全称、中文10个*2共20分 二，单词、词组的英汉互译5个*2共10分 三，问答计算（in English）5个*4共20分 四，单选20个*1共20分 五，名词解释10个*2共20分 六，计算2个*5共10分
一，写出英文缩写的全称、中文10个*2共20分 GLP (Good Laboratory Practice )药物非临床研究质量管理规范 GMP (Good Manufacture Practice )药品生产质量管理规范 GSP (Good Supply Practice)药品经营质量管理规范 GCP (Good Clinical Practice)药物临床试验质量管理规范 QA(Quality Assurance)质量保证 QC（Quality Control) 质量控制 UV（Ultraviolet Spectrophotometry）紫外光谱法 IR(Infrared Spectrophotometry)红外光谱法 TLC（Thin layer Spectrophotometry)薄层色谱法 HPLC(High Performance Liquid Chromatography)高效液相色谱法 GC(Gas Chromatography)气相色谱法 PC（Paper Chromatography)纸色谱法 FID(Flame Ionisation Detector)氢火焰离子化检测器 FDA(Food and Drug Administration)食品药品监督管理局 SD(Standard Deviation)标准偏差 RSD(Relative Standard Deviation)相对标准偏差 LOD(Limit of Detection)检测限 LOQ(Limit of Quantitation)定量限 Chp(Pharmacopoeia of The People’s Republic of China)中国药典 USP (United States Pharmacopoeia)美国药典 NF（National Formulary）美国国家处方集 BP(British Pharmacopoeia)英国药典 JP（Japanese Pharmacopoeia)日本药局方
二，单词、词组的英汉互译5个*2共10分 Linearity and Range线性和范围 Repeatability and reproducibility 可重复性和可重现性 Accuracy and Precision准确度和精密度 Standard Operation Procedure（SOP）标准操作程序 Non-aqueous titrations非水滴定 Void volume死体积 Capacity factor容量因子 精品文档 可编辑 Column efficiency（column performance）柱效 Resolution分离度、分辨率 System suitability 系统适应性试验 Theoretical plates 理论塔板数 Peak symmetry 峰对称性 Peak retention times峰保留时间 Mobile phase流动相 Stationary phase 固定相 Carrier gas载气 Pharmaceutical analysis 药物分析 Titration滴定 Standard solution标准溶液 Heavy metal重金属 Loss on drying干燥失重 Selectivity选择性 Ruggedness（or robustness）耐用度 Analytical blank空白分析 Sensitivity灵敏度
三，问答计算（in English）5个*4共20分 1 Accuracy：The closeness of the assay result obtained by the assay method to the true value How？Recovery studies
2 Precision：The degree of agreement among individual assay results when the assay method is applied repeatedly to multiple sampling of a homogeneous sample How？relative standard deviation (RSD) or coefficient of variation (CV)
3 LOD: The smallest amount of an analyte which can be detected by a particular method.
4 Range：The range of the assay method is the interval between the upper and lower levels (inclusive) of analyte that have been determined.
5 Ruggedness（or robustness）：The degree of the reproducibility of the assay results obtained by the analysis of the same sample under a variety of normal test conditions
6 Selectivity (or specificity)：The selectivity of a method is a measure of how capable it is of measuring the analyte in the presence of other compounds contained in the sample.
7 Sensitivity：The sensitivity of method indicates how respondsive it is to a small 精品文档 可编辑 change in the concentration of an analyte. 8 indicator: An indicator is a weak acid or base that changes colour between its ionized and un-ionised forms.
9 What are primary standards? Primary standards are stable chemical compounds that are available in high purity and which can be used to standardise the standard solutions used in titrations.
10 What is Beer-lambet law? A=ECL A is the absorbance. E is the extinction coefficient of the analyte. C is the concentration of the analyte. L is the thickness of the solution
11 What are the Components of a UV-vis spectrophotometer? Lamps、slit、monochromator、slit、quartz cell、detector
12 4.2What are the concentrations of the following solutions of drugs in g/100ml and mg/100ml 4.4 Calculate the percentage of stated content of promazine hydrochloride in promazine tablets from the following information 4.5 Determine the concentration of the following injections（答案见英文讲义）
13 What are the Components of a HPLC system? solvent reservoir → pump → injection loop → column → UV/vis detector →integrator
14 What is the ‘Rf value’ of a compound in a TLC chromatogram? The distance travelled by the compound from the origin (where the compound is put onto the plate) divided by the distance travelled by the solvent from the origin is called the ‘Rf value’ of the compound.
四，略(看原来的资料) 五，略（看原来的资料） 六，计算2个*5共10分 示例一 茶苯拉明中氯化物检查 取本品0.30g 置200 ml量瓶中，加水50ml、氨试液3ml和10%硝酸铵溶液6ml，置水浴上加热5min，加硝酸银试液25ml，摇匀，再置水浴上加热15min，并时时振摇，放冷，加水稀释至刻度，摇匀，放置15min，滤过，取续滤液25ml置纳氏比色管中，加稀硝酸10ml，加水稀释至50ml，摇匀，在暗处放置5min，与标准氯化钠溶液(10μg Cl-/ml)1.5 ml制成的对照液比较，求氯化物的限量。
