专业课-《药物分析》课程教学大纲(英文班)

《Pharmaceutical Analysis》课程教学大纲
适用对象：供药学专业本科学生使用
（学分：3 学时：54 ）
Grade：2016 Speciality: Pharmacy Teacher: Chen Na
Total class hours: 54 Teaching hours: 36 Experiment hours: 18
1. Introduction
Pharmaceutical Analysis is an essential course that contributes basic theory, elementary knowledge and scientific principles to diseases prevention and rational use of drug. It is also a double bridge that links medicine and pharmacy, basic medicine and clinical medicine.
2. Teaching purpose and contents
Chapter 1 Introduction and Pharmacopoeia
【Teaching purpose and requirements】
1) To master the aims and purpose of pharmaceutical analysis.
2) To master Chinese Pharmacopoeia and learn other Pharmacopoeia.
3) To master procedure of drug test.
【Teaching Contents】
1) Components of a medical product
2) Formation of a medical product
3) The aims and purpose of pharmaceutical analysis
4) Questions pharmaceutical analysis methods are used to answer
5) Subsection of Chinese Pharmacopoeia and other Pharmacopoeia
Chapter 2 Chemical Analysis of Drug Substances (Identification)
【Teaching purpose and requirements】
1) To learn items of identification test.
2) To understand the principle and method of identification test.
【Teaching Contents】
1) Items of identification tests
2) General identification tests
3) Specific identification tests
4) Identification methods
Chapter 3 Chemical Analysis of Drug Substances (Impurity Tests)
【Teaching purpose and requirements】
1) To master the sources of impurities and the method of the limit test for impurities.
2) To master the principles and methods of chlorides, heavy metals, etc.
3) To understand the methods of loss on drying and residue on organic solvents.
4) To learn the principles of special impurities tests.
【Teaching Contents】
1) Origin and nature of Phar. raw material
2) Contaminants in raw material and purity requirement
3) Test of general impurities: appearance of solution, absorbance, specific optical rotation, heavy metals, loss on drying, etc.
Chapter 4 Chemical Analysis of Drug Substances (Assay)
【Teaching purpose and requirements】
1) To learn the preparation of samples of drug quantitative analysis.
2) To understand the characters of drug quantitative analysis.
3) To understand the aims and purposes of validation.
4) To learn the aims of biological samples.
【Teaching Contents】
1) Quantification of drugs: titrimetric analysis methods, spectroscopic analysis methods, chromatographic analysis methods
2) Validation of analytical procedure
Chapter 5 Sample Preparation and Analysis of Drugs in Biological Fluids
【Teaching purpose and requirements】
1) To learn methods of ample preparation.
2) To master the analysis methods of drugs in biological fluids.
【Teaching Contents】
1) Sample preparation
2) Analysis of drugs in biological fluids
Chapter 6 Analysis of Aromatic acid-Nonsteroidal Anti-inflammatory Drugs
【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of aromatic carboxylic acids.
2) To master the identification methods of aromatic carboxylic acids.
3) To master the source of special impurities of aromatic carboxylic acids and tests.
4) To master the assay of aromatic carboxylic acids.
【Teaching Contents】
1) Structures and chemical properties of aromatic carboxylic acids.
2) Identification methods of aromatic carboxylic acids.
3) Detection of related substances in aromatic carboxylic acids.
4) Assay of aromatic carboxylic acids.
Chapter 7 Analysis of Phenethylamine Adrenomimetic Drugs
【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of phenethylamines.
2) To master the identification methods of phenethylamines.
3) To master the source of special impurities of phenethylamines and tests.
4) To master the assay of phenethylamines.
【Teaching Contents】
1) Structures and properties of phenethylamines.
2) Identification methods of phenethylamines.
3) Detection of special impurities in phenethylamines.
4) Assay of phenethylamines.
Chapter 8 Analysis of p-Aminobenzoic Ester and Anilide-based Local Anesthetics 【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of p-aminobenzoic esters and anilides.
2) To master the identification methods of p-aminobenzoic esters and anilides.
3) To master the source of special impurities of p-aminobenzoic esters and anilides and tests.
4) To master the assay of p-aminobenzoic esters and anilides.
【Teaching Contents】
1) Structures and chemical properties of p-aminobenzoic esters and anilides.
2) Identification methods of p-aminobenzoic esters and anilides.
3) Detection of related substances in p-aminobenzoic esters and anilides.
4) Assay of p-aminobenzoic esters and anilides.
Chapter 9 Analysis of Dihydropyridine Calcium Channel Antagonists
【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of dihydropyridines.
2) To master the identification methods of dihydropyridines.
3) To master the source of special impurities of dihydropyridines and tests.
4) To master the assay of dihydropyridines.
【Teaching Contents】
1) Structures and chemical properties of dihydropyridines.
2) Identification methods of dihydropyridines.
3) Detection of related substances in dihydropyridines.
4) Assay of dihydropyridines.
Chapter 10 Analysis of Barbiturate and Benzodiazepine Sedative-hypnotic Drugs 【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of barbiturates and benzodiazepines.
2) To master the identification methods of barbiturates and benzodiazepines.
3) To master the source of special impurities of barbiturates and benzodiazepines and tests.
4) To master the assay of barbiturates and benzodiazepines.
【Teaching Contents】
1) Structures and chemical properties of barbiturates and benzodiazepines.
2) Identification methods of barbiturates and benzodiazepines.
3) Detection of related substances in barbiturates and benzodiazepines.
4) Assay of barbiturates and benzodiazepines.
Chapter 11 Analysis of Phenothiazine Antipsychotic Drugs
【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of phenothiazines.
2) To master the identification methods of phenothiazines.
3) To master the source of special impurities of phenothiazines and tests.
4) To master the assay of phenothiazines.
【Teaching Contents】
1) Structures and chemical properties of phenothiazines.
2) Identification methods of phenothiazines.
3) Detection of related substances in phenothiazines.
4) Assay of phenothiazines.
Chapter 12 Analysis of Quinolone and Artemisinin-based Anticholinergic Drugs 【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of quinolones and artemisinins.
2) To master the identification methods of quinolones and artemisinins.
3) To master the source of special impurities of quinolones and artemisinins and tests.
4) To master the assay of quinolones and artemisinins.
【Teaching Contents】
1) Structures and chemical properties of quinolones and artemisinins.
2) Identification methods of quinolones and artemisinins.
3) Detection of related substances in quinolones and artemisinins.
4) Assay of quinolones and artemisinins.
Chapter 13 Analysis of Tropane Alkaloid-based Anticholinergic Drugs
【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of tropane alkaloids.
2) To master the identification methods of tropane alkaloids.
3) To master the source of special impurities of tropane alkaloids and tests.
4) To master the assay of tropane alkaloids.
【Teaching Contents】
1) Structures and chemical properties of tropane alkaloids.
2) Identification methods of tropane alkaloids.
3) Detection of special impurities in tropane alkaloids.
4) Assay of tropane alkaloids.
Chapter 14 Analysis of Vitamins
【Teaching purpose and requirements】
1) To master the characters of structures and chemical properties of Vitamins.
2) To master the identification methods of tropane Vitamins.
3) To master the source of special impurities of Vitamins and tests.
4) To master the assay of Vitamins.
【Teaching Contents】
1) Structures and chemical properties of Vitamins.
2) Identification methods of tropane Vitamins.
3) Detection of special impurities in Vitamin D and Vitamin E.
4) Assay of Vitamin A and Vitamin C.
3. Teaching important and difficult points
Important points: Identification, impurity test, analysis of each type of drugs.
Difficult points: Assay methods and calculation.
4. Teaching Schedule
5. Experiments
6. Reference books：
(1)《药物分析》杭太俊主编第8版
(2)《药物分析》刘文英主编安登魁主编
(3)《药物分析及应用》马广慈主编
(4)《Introduction to Pharmaceutical Chemical Analysis》(2012), Chief editor:Steen Hansen, Stig Pedersen-Bjergaard, Knut Rasmussen
(5)《Pharmaceutical Analysis》, 3th Edition, Chief editor: David G. Aatson
(6) 《药物分析实验与指导》，宋敏主编，第三版。