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: 82013
E-mail: wangwhsdu@163.com
Introduction
Pharmaceutical analysis
Administer of total quality control
of drugs
General procedure of drug analysis
Main Contents and Requirements
1. Pharmaceutical analysis
1.1 Definition
Pharmaceutical analysis is an
applied science dealing with the
establishment and development
of quality control methods of
drugs and their preparations.
 Quality Control
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.
Methods and Techniques
Chemical analytical method
Spectroscopy
Chromatography
Biochemical method
Biological method
Ultraviolet and
Visible
Spectrophotometry
Fluorescence
Spectrophotometry
Chromatography
1.2 Roles
an important part of pharmaceutics
Discovery Medicinal
Chemistry
pharmacology Activity
pharmaceutical
Quality
Analysis
Preparation
Formation
1.3 Duties
Total quality control of drugs
New drug
discovery
and
development
Clinical use
Manufacture
process
Distribution
To supply analytical methods for the
development of new drugs
Eample： Drug screening
Chemometrics
Automatization
New Drug
Discovery
and
Development
Microdosing
Studies
Instrumental
Analysis
Nanotechnology
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
NH2
O
H2N S
N N
NH2
O
Determined
in plasma
ang urine
NH2
O
H2N S
O
NH2 + H2N
NH2
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
SECOND EDITION
Pharmaceutical Analysis
A Textbook for Pharmacy Students
and Pharmaceutical Chemists
Edited by David G. Watson
 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 HarMonisation 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
Quality Technical Requirements—Q
13 document：Q1，Q2，Q3，Q4，Q5
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
Reporting
Assay
 Sampling
x≤3，sampling from every package
3＜x≤300，
x 1
x﹥300时，
x 2 1
 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
3. Administer of total quality control
of drugs
GMP :
GLP :
GSP :
GCP :
Good Manufacturing Practices
Good Laboratory Practices
Good Supply Practices
Good Clinical Practices
AQC : Analytical Quality Control
4. The main contents of
pharmaceutical analysis
The course in pharmaceutical
analysis is a specialized course.
It is an important part of
pharmaceutics
main contents
•Analysis of 7 types of drug
materials
• Limit test
• Analysis of pharmaceutical
preparations
•Biopharmaceutical analysis
•Introductin of drug standards
• Application of modern
chromatography and
spectrophotometry in
pharmaceutical analysis
5. Requirements
Chemical
Structure
（Functional
Group）
Analytical
Method
Physical and
Chemical
Properties
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， 2002.
• 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：www.wanfangdata.com.cn
维普期刊数据库，
网址：www.cqvip.com
CNKI数据库，
网址：www.cnki.netPubMed，
网址：www.ncbi.nlm.nih.gov
中国食品与药品管理局(SFDA)，
http://www.cde.org.cn
MEDLINE http://www.ncbi.nlm.nih.gov/pubmed/
美国药学杂志(JPharm Sci)
http://pubs.acs.org/journals/jpmsae/index.html
药学信息(Drug Topics)
http://www.drugtopics.com/
在线中药查询 http://www.herbonline.com/
美国专利 http://www.uspto.gov/
欧美专利 http://ep.espacenet.com/