药物分析期末复习资料

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

V oid volume死体积

Capacity factor容量因子

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

2Precision：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.

5Ruggedness（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 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.