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1、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 Prac
2、tice)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 Ionisat
3、ion 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 Peoples Republic of China)中国药典USP (United States Pharmacopoeia)美国药典NF（National Formulary）美国国
4、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Column efficiency（colu
5、mn 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 robus
6、tness）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 valueHow？Recovery studies 2 Precision：The degree of agreement among individual assay results when the assay method is applied repeatedly to multi
7、ple sampling of a homogeneous sampleHow？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 an
8、alyte 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 me
9、asuring 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 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-
10、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=ECLA is the absorbance.E is the extinction coefficient of the anal
11、yte.C is the concentration of the analyte.L is the thickness of thesolution11 What are the Components of a UV-vis spectrophotometer?Lamps、slit、monochromator、slit、quartz cell、detector12 4.2What are the concentrations of the following solutions of drugs in g/100ml and mg/100ml4.4 Calculate the percent
12、age of stated content of promazine hydrochloride in promazine tablets from the following information4.5 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 integrator14 What is the Rf
13、 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0.3
14、0g 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(10g Cl-/ml)1.5 ml制成的对照液比较，求氯化物的限量。C=10 g/ml V=1.5 ml S=0.3*25/200示例三 肾上腺素上酮体的检查取本品0.2g,置100ml量瓶中，加盐酸溶液(9-2000)溶解并稀释至刻度，摇匀，在310nm处测定吸光度
15、不得超过0.05，酮体的百分吸收系数为435，求酮体的限量C=A/E=0.05/435=1.1510-4 g/100ml V=100 ml S=0.2 g1.取本品0.10 g,加盐酸溶液(9-1000)使溶解成5ml，加亚硝酸钠试液2ml，放置15min，加氨试液3ml，所显颜色与吗啡试液取无水吗啡2.0mg，加盐酸溶液(9-1000)使溶解成100ml 5.0ml用同一方法制成的对照液比较，不得更深。问限量是多少？2.取本品2.0g,加水32ml，溶解后缓缓加入1mol/L盐酸溶液8ml，充分振摇，静置数分钟，滤过，取滤液20ml，加酚酞指示液1滴与氨试液恰显粉红色，加醋酸盐缓冲液(pH3.5)2ml与水适量成25ml，依法检查，含重金属不得超过10ppm。试计算应取得标准铅溶液(每1ml相当于10g Pb)的体积。习题一 磷酸可待因中吗啡的检查取本品0.10 g,加盐酸溶液(9-1000)使溶解成5ml，加亚硝酸钠试液2ml，放置15min，加氨试液3ml，所显颜色与吗啡试液取无水吗啡2.0mg，加盐酸溶液(9-1000)使溶解成100ml 5.0ml用同一
