主讲教师：王唯红、王海钠、刘秀美 联系方式： 药物分析研究室 教学七楼三层 7306 室 TEL:

Pharmaceutical analysis Introduction Main Contents and Requirements General procedure of drug analysis Administer of total quality control of drugs

1.1 Definition Pharmaceutical analysis is an applied science dealing with the establishment and development of quality control methods of drugs and their preparations. 1. Pharmaceutical analysis

Drugs are special products used for prevention,therapy and diagnosis of diseases, and for promotion of the functionality of human body. Quality control and analysis of drugs are very important means to guarantee their safe and effective use.  Quality Control

 Methods and Techniques Chemical analytical method Chemical analytical method Spectroscopy Chromatography method Biochemical method method Biological method

Ultraviolet and Visible Spectrophotometry Fluorescence Spectrophotometry

Chromatography

Preparation 1.2 Roles Discovery Activity Quality Formation Medicinal Chemistry pharmacology pharmaceutical Analysis an important part of pharmaceutics

Total quality control of drugs Clinical use Distribution Manufacture process New drug discovery and development 1.3 Duties

To supply analytical methods for the development of new drugs Eample ： Drug screening

Chemometrics Automatization New Drug Discovery and Development Instrumental Analysis Nanotechnology Microdosing Studies High-throughput Analysis

Manufacture process Process Analytical Technology （ PAT ） in-process reaction analysis in-process particle analysis Distribution Store Transport Market

Drugs in Use Therapeutic Drug Monitoring Pharmacokinetics Pharmacodynetics Drug Abuse Overdosage Analytical Toxicology Drugs in Sport(Doping Control)

Therapeutic Drug Monitoring Determination concentration of digoxin in plasma TDM Pharmacokinetics Research and development of new drug Determined in plasma ang urine

Pharmaceutical analysis is a comprehensive applied analytical science that uses the classical and modern analytical measures to study the property of drugs, to plan the drug standards, and to control the quality of drugs.

1.4 Developments of Pharmaceutical Analysis Analysis of Traditional Chinese Medicine Traditional Chinese medicine fingerprints

Pharmacokinetics and Bioavailability absorption distribution metabolism biotransformation excretion New Techniques automatization miniaturization high sensitive hyphenation techniques

Embranchment subjects: Biopharmaceutical analysis Pharmaceutical analysis in industrial Pharmaceutical calculation analysis Pharmaceutical chromatography Pharmaceutical spectrometry

 Teaching,Course and Textbook

Pharmaceutical Analysis A Textbook for Pharmacy Students and Pharmaceutical Chemists Edited by David G. Watson SECOND EDITION

 Quality Standard: Pharmacopoeia of The Republic of China Chinese Pharmacopoeia Ch.P (2005) 《中国药典》 2005 年版

Quality Standard of State Food and Drug Administration

 Study on drug quality standard International Conferenceon Har- Monisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) 人用药品注册技术规范的国际协调会 质量的技术要求

13 document ： Q1 ， Q2 ， Q3 ， Q4 ， Q5 Quality Technical Requirements—Q Q1A(R2) ： Stability Testing of New Drug Substances and Products Q3B(R) ： Impurities in New Drug Products

2. The general procedure of drug analysis Sampling Identification Limit Test Assay Reporting

 Sampling x≤3 ， sampling from every package 3 ＜ x≤300 ， x ﹥ 300 时，

 Identification Identification test is a means to confirm the identity of drug (true or false). general identification test specific identification test

 Limit Test Detect impurities in drugs.  Assay the content determination of drugs assay of potency Reporting  Reporting

3. Administer of total quality control of drugs GMP : Good Manufacturing Practices GMP : Good Manufacturing Practices GLP : Good Laboratory Practices GLP : Good Laboratory Practices GSP : Good Supply Practices GSP : Good Supply Practices GCP : Good Clinical Practices GCP : Good Clinical Practices AQC : Analytical Quality Control AQC : Analytical Quality Control

The course in pharmaceutical analysis is a specialized course. It is an important part of pharmaceutics 4. The main contents of pharmaceutical analysis

Analysis of 7 types of drug materials Limit test Analysis of pharmaceutical preparations Biopharmaceutical analysis main contents

Introductin of drug standards Application of modern chromatography and spectrophotometry in pharmaceutical analysis

5. Requirements Chemical Structure （ Functional Group ） Physical and Chemical Properties Analytical Method Reaction Mechanism

Chemical structure-analytical method relationships Drug Standards Sample preparation and validation of analytical method Methods of identification, limit test and assay of drugs Analysis of biological samples

6. Reference 刘文英主编《药物分析》，第六版 人民 卫生出版社， 2007 ， 8. 张君仁主编《体内药物分析》 ，化学工 业版社， 国家药典委员会编《中国药典》（ 2005 年版），化工出版社， 2005 ， 1. 安登魁主编，《现代药物分析选论》， 中国医药科技出版社， 2001 ， 1 。

姚彤伟编著，《体内药物分析》 浙江大 学出版社 ， 2001 ， 1. 李好枝主编《体内药物分析》 人民卫生 出版社 ， 2003 ， 8 李发美主编，分析化学（第六版），人民 卫生出版社， 2007 D. G. Watson, Pharmaceutical Analysis, 1999, Churchill Livingstone, London.

药物分析杂志 药学学报 中国药学杂志 中国医药工业杂志 中国医院药学杂志 色谱 分析化学 中草药 Analytical and Bioanalytical Chemistry Anal Chem. J. pharm. Biomed. Anal Biomedical Chromatography Clinical Pharmacokinetics Journal of Chromatography A., Journal of Chromatography B.

主要数据库 万方数据库（数字化期刊子系统）， 网址： 维普期刊数据库， 网址： CNKI 数据库， 网址： ， 网址： 中国食品与药品管理局 (SFDA) ，

MEDLINE 美国药学杂志 (JPharm Sci) 药学信息 (Drug Topics) 在线中药查询 美国专利 欧美专利