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1、Chapter 1 Introduction to General Pharmacology 【Learning points】一、一、Nature and tasks of pharmacology 1.Drug：A chemical substance that can change or ascertain the physiological function and pathological state of the body,and can be used to prevent,diagnose,and treat diseases.There are no strict bound
2、aries between drugs and poisons.2.Pharmacology：A discipline that studies the interaction and action law of drugs and the body(including pathogens).It not only studies the effects and mechanisms of drugs on the body,that is,pharmacodynamics;but also studies the drugs in the body.The changes and their
3、 laws that occur under the influence of pharmacokinetics.3.Learning content:Pharmacology is a bridge subject linking basic medicine and clinical medicine as well as medicine and pharmacy.It provides a basic theoretical basis for the rational use of medicine in the clinic and the prevention and treat
4、ment of diseases.When studying,we must understand and master the basic laws of pharmacology(pharmacodynamics and pharmacokinetics),the pharmacodynamics and pharmacokinetics of representative drugs and commonly used drugs in various types of drugs,and their indications and contraindications.4.Discipl
5、inary tasks of pharmacology Clarify the role and mechanism of drugs,and provide a theoretical basis for rational clinical use of drugs,exert the best effects of drugs,and prevent and treat adverse reactions;Research and develop new drugs and discover new uses of drugs;For other life science research
6、 Exploration provides important scientific basis and research methods.5.Experimental methods of pharmacology are divided into:experimental pharmacological methods;experimental therapeutic methods;clinical pharmacological methods.二、二、History of the development of drugs and pharmacology 1.The herbalis
7、m stage:The main content is to record human experience in treating diseases with drugs since prehistory.Among them,Compendium of Materia Medica was translated into 7 languages,which played an extremely important role in the development of world medicine.2.The stage of modern pharmacology First,the d
8、evelopment of chemistry and physiology.These work created experimental methods for the development of pharmacology.Proposed the concept of receptor,which laid the foundation for the establishment of receptor theory.The development of organic chemistry and experimental medicine has brought the resear
9、ch and development of medicine into a new stage.In recent years,with the rapid development of other disciplines and the application of new technologies in pharmacology,the development of pharmacology is also making rapid progress in depth and breadth.三、三、New Drug Development and Research 1.New drugs
10、:Drugs whose chemical structure,drug components or pharmacological effects are different from existing drugs.Refers to drugs that have not been marketed in China.It is also within the scope of new drugs to change the dosage form,change the route of administration,and add new indications for drugs al
11、ready on the market.2.The development of new drugs:It is a very strict and complicated process.It can be divided into three stages:preclinical research,clinical research and postmarketing surveillance.(1)Pre-clinical pharmacology research Pharmacodynamics,pharmacokinetics and toxicology research whi
12、ch mainly aimed to experimental animals.(2)Clinical research of new drugs is generally divided into four phases.Phase I clinical trial is a preliminary pharmacological and human safety test conducted on 20-30 normal adult volunteers,which is the initial stage of the new drug human trial,and provides
13、 a scientific basis for subsequent research;Phase II clinical trial is random double-blind Controlled clinical trials,observing no less than 100 pairs of cases,mainly to make a preliminary evaluation of the effectiveness and safety of the new drug,and to recommend the clinical dosage;Phase III clini
14、cal trials are before the new drug is approved for marketing.The purpose of the central clinical trial is to conduct social investigations on the effectiveness and safety of new drugs.The number of observations should not be less than 300.New drugs can only be approved for production and marketing a
15、fter passing this phase of clinical trials;Phase IV clinical trials are the safety and effectiveness evaluation of the new drugs tested in the wide range of social populations after the market,under the conditions of extensive long-term use.Efficacy and adverse reactions,also called postmarketing surveillance,are of great significance for the final establishment of the clinical value of new drugs.