药物分析-诸论-2012

Pharmaceutical Analysis

药物分析

王 彦

Phone: 34205673(O); E-mail:wangyan11@http://www.77cn.com.cn Office: 6-304

Introduction

Definition

Drugs

are special products used for prevention and therapy of diseases, and for promotion of the functionality of human body.

Safety Effectiveness

particularity of drug

The Dual character specificity Extreme importance - quality control Professional

Pharmaceutical Analysis

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

Importance

Analysis of drugs and Quality control are very important means to guarantee their safe and effective use.

The

relationship between Pharmaceutical Analysis and Analytical Chmistry. The key is analysis.

Duties

1. Total Quality Control of Drugs—the base duties: Starting materials, intermediates, and products production process: quality control storage process: quality investigation

Duties

2. The new drug development-the important duties

establishing and developing methods of quality control of drugs the studies of stalibity the studies of pharmacokinetic

the studies of bioavailability

Duties

3. Clinical uses—provide help for the related studies

Therapeutic Drug Monitoring（治疗药物监测） Clinical pharmacology（临床药理学） Biopharmaceutics（生物药剂学）

Chemic al analysis

gravimetric analysis

acid-base titrations complexmetric titration

volumetric analysis

oxidation-reduction titration precipitation titration

Pharmaceutical Analysis

electrochemical analysis

Conductometry（电导）、 potentiometry（电 位）， electrolytic analysis（电解）、 coulometric analysis（库仑）、 polarography （极谱）、voltammetry（伏安）.

photochemical analysis

UV, IR, FI GC、LC、TLC

Instrume ntal analysis

2013-7-27

Chromatographi c analysis

Spectrum analysis

NMR、MS

Difficulities

Complicated

ingredient：Chinese tratidional medicine The amount is very small （microamount, trace amount)。

The tendency of modern pharmaceutical analysis

药品管理理念

检验控制质量

生产控制质量 设计控制质量

分析对象 静态分析 体外分析 小样本 动态分析 体内分析 高通量 生物活性分析 复杂体系

品质分析

简单成分

分析技术

单一技术

人工分析

联用技术 超微量分析

自动化分析、计算机辅助设计

常量分析

Drug Standardization

Pharmacopoeia of the People’s Republic of China(， Chinese Pharmacopoeia, Ch.P ) （中华人民共和国药典，

简称中国药典）-National drug standards

Ministerial Drug Standards（国家药品标准，简称为局标 准）-as supplements to the national pharmacopoeia