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1、第六编第六编药物治疗学基础Section VIPharmacological basis of drug therapeuticsGeneral PrinciplesGeneral ConceptsGeneral ConceptsHistoryHistoryThe Nature of DrugsThe Nature of DrugsMethodology of PharmacologyMethodology of PharmacologyNew Drug Research and DevelopmentNew Drug Research and DevelopmentGeneral Conce
2、ptsHuman disease: prevention and treatment Drug therapy Drug therapy Surgery Surgery Radiotherapy Radiotherapy Physical therapy Physical therapy Psychological therapy Psychological therapy药理学是药物治疗学的基础理论药理学是药物治疗学的基础理论药理学是药物治疗学的基础理论药理学是药物治疗学的基础理论General ConceptsPharmacologyPharmacology can can be be d
3、efined defined as as the the study study of of substances substances that that interact interact with with living living systems systems through through chemical chemical processes, processes, especially especially by by binding binding to to regulatory regulatory molecules molecules and and activat
4、ing activating or or inhibiting normal body processes.inhibiting normal body processes. Medical Medical PharmacologyPharmacology is is often often defined defined as as the the science science of of substances used to prevent, diagnose, and treat disease. substances used to prevent, diagnose, and tr
5、eat disease. Katzung BG (Ed). Basic & Clinical Pharmacology (11th Edition). New York: McGraw-Hill, 2010.药理学是研究药物与机体（包括人体和病原体）相互作用的规药理学是研究药物与机体（包括人体和病原体）相互作用的规药理学是研究药物与机体（包括人体和病原体）相互作用的规药理学是研究药物与机体（包括人体和病原体）相互作用的规律及其原理，是一门为临床合理用药防治疾病提供基本理论的律及其原理，是一门为临床合理用药防治疾病提供基本理论的律及其原理，是一门为临床合理用药防治疾病提供基本理论的律及其原理，是
6、一门为临床合理用药防治疾病提供基本理论的医学基础学科。医学基础学科。医学基础学科。医学基础学科。What is Pharmacology studied?PharmacodynamicsPharmacodynamics（药药药药效效效效动动动动力力力力学学学学，药药药药效效效效学学学学）: : the the actions actions of the drug on the body and the mechanismsof the drug on the body and the mechanismsPharmacokineticsPharmacokinetics（药药药药代代代代动动动
7、动力力力力学学学学，药药药药动动动动学学学学）: : the the actions actions of of the body on the drugsthe body on the drugsFactorsFactors（影响因素）（影响因素）（影响因素）（影响因素）： influencing the processes of influencing the processes of pharmacodynamics and pharmacokineticspharmacodynamics and pharmacokineticsDrugsDrugsHuman Human BodyBod
8、yPharmacodynamics Pharmacodynamics （药效学）（药效学）（药效学）（药效学）Action and mechanismAction and mechanismPharmacokineticsPharmacokinetics（药动学）（药动学）（药动学）（药动学）Absorption, distribution, Absorption, distribution, metabolism, excretion, and drug metabolism, excretion, and drug concentration in the bodyconcentratio
9、n in the bodyInteraction between drug and human bodyInteraction between drug and human body药物与人体的相互作用药物与人体的相互作用药物与人体的相互作用药物与人体的相互作用HumanHumanPathogensPathogensDrugDrugInteractions between drug , human body, Interactions between drug , human body, and pathogensand pathogens药物、人体和病原体之间的相互作用药物、人体和病原体之间
10、的相互作用药物、人体和病原体之间的相互作用药物、人体和病原体之间的相互作用PharmacyPharmacy药学药学药学药学Pharmacology药理学药理学药理学药理学TherapeuticsTherapeutics治疗学治疗学治疗学治疗学Basic ResearchBasic Research基础研究基础研究基础研究基础研究New DrugNew Drug新药研制新药研制新药研制新药研制Clinical Clinical PharmacologyPharmacologyLife ScienceLife ScienceScreening Screening and and Evaluatio
11、nEvaluationThe Goals of PharmacologyDrugsDrugsHistoryRemedies in China and Egypt,Remedies in China and Egypt, recognized and recognized and recorded the beneficial and toxic effects of many recorded the beneficial and toxic effects of many plant and animal materials. 2500 years ago plant and animal
12、materials. 2500 years ago 17th century. 17th century. 本草学本草学本草学本草学Materia medica,Materia medica, the science of drug preparation the science of drug preparation and the medical use of drugs: the precursor and the medical use of drugs: the precursor pharmacology. End of 17th cetury pharmacology. End
13、of 17th cetury 18th century18th century. . 药物学药物学药物学药物学2 HistoryTraditional pharmacology:Traditional pharmacology: developing the methods developing the methods of experimental physiology and pharmacology; of experimental physiology and pharmacology; advances in chemistry. 18th century advances in c
14、hemistry. 18th century early of 20th early of 20th century. century. 经典药理学经典药理学经典药理学经典药理学Modern pharmacology:Modern pharmacology: concepts of rational concepts of rational therapeutics, especially that of the controlled therapeutics, especially that of the controlled clinical trials; a major expansi
15、on of research efforts clinical trials; a major expansion of research efforts in all areas of biology, 20th century in all areas of biology, 20th century ; rapid ; rapid growth of information and understanding of the growth of information and understanding of the molecular basis for drug action, las
16、t 3 decadesmolecular basis for drug action, last 3 decades. . 现代药理学现代药理学现代药理学现代药理学Rudolf Buchheim(1820-1879)Founder of Founder of experimental experimental pharmacologypharmacology药物：药物：药物：药物：影响机体生理、生化功能，能够用于诊断、预防影响机体生理、生化功能，能够用于诊断、预防影响机体生理、生化功能，能够用于诊断、预防影响机体生理、生化功能，能够用于诊断、预防和治疗疾病的物质。和治疗疾病的物质。和治疗疾病的
17、物质。和治疗疾病的物质。药品：药品：药品：药品：指用于预防、治疗、诊断人的疾病，有目的地调指用于预防、治疗、诊断人的疾病，有目的地调指用于预防、治疗、诊断人的疾病，有目的地调指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应证、用法和用量的物质节人的生理机能并规定有适应证、用法和用量的物质节人的生理机能并规定有适应证、用法和用量的物质节人的生理机能并规定有适应证、用法和用量的物质，包包包包括中药材、中药饮片、中成药、化学原料药及其制剂、抗括中药材、中药饮片、中成药、化学原料药及其制剂、抗括中药材、中药饮片、中成药、化学原料药及其制剂、抗括中药材、中药饮片、中成药、化学原料药及
18、其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊生素、生化药品、放射性药品、血清疫苗、血液制品和诊生素、生化药品、放射性药品、血清疫苗、血液制品和诊生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。断药品等。断药品等。断药品等。药物和药品的概念药物和药品的概念The Nature of Drugs3.1 The physical nature of drugs 药物的理化特性药物的理化特性药物的理化特性药物的理化特性 Solid:Solid: e.g.e.g. aspirin, atropine aspirin, atropine Liquid:Liquid: e.g.e
19、.g. nicotine, ethanol nicotine, ethanol Gaseous:Gaseous: e.g. e.g. ether, nitrous oxide ether, nitrous oxideThe Nature of Drugs3.2 Drug size 药物的大小药物的大小药物的大小药物的大小 Very small:Very small: lithium ion (MW 7)lithium ion (MW 7) Very large: Very large: t-PA (MW 59,050)t-PA (MW 59,050) Most:Most: MW between
20、 100 1,000MW between 100 1,000The Nature of Drugs3.3 Drug reactivity and drug-receptor bonds 药物反应性及药物药物反应性及药物药物反应性及药物药物反应性及药物- -受体作用力受体作用力受体作用力受体作用力 Chemical forces:Chemical forces: covalent, electrostatic, hydrophobiccovalent, electrostatic, hydrophobicThe Nature of Drugs3.4 Drug shape 药物的形状药物的形状药物
21、的形状药物的形状Optimally, Optimally, the the shape shape of of a a drug drug is is complementary complementary to to that that of of the the receptor receptor site site in in the the same same way way that that a a key key is is complementary to a plementary to a lack.The phenomenon ofThe phenomenon of chi
22、rality ( (手性）手性）(steroisomerism) is so common in (steroisomerism) is so common in biology that more than half of all useful biology that more than half of all useful drugs are chiral molecles, i.e. they exist drugs are chiral molecles, i.e. they exist as enantiomeric pairs.as enantiomeric pairs.The
23、Nature of Drugs3.5 Rational drug design 基于分子结构的药物设计基于分子结构的药物设计基于分子结构的药物设计基于分子结构的药物设计 As As more more becomes becomes known known about about target target structures structures and and computer computer programs programs are are now now available, available, rational rational drug drug design design
24、 based based on on computer computer will will become more feasible.become more feasible.The Nature of Drugs3.6 Drug resources and preparationNature sourcesNature sources天然来源天然来源天然来源天然来源SynthesisSynthesis合成合成合成合成BioengineeringBioengineering生物工程生物工程生物工程生物工程Dose FormsDose Forms剂型剂型剂型剂型HumanHumanPharma
25、cy Pharmacy 药学药学药学药学PharmacologyPharmacology药理学药理学药理学药理学新药定义：新药定义：未曾在中国境内上市销售的药品未曾在中国境内上市销售的药品未曾在中国境内上市销售的药品未曾在中国境内上市销售的药品。旧旧定定义义：我我我我国国国国尚尚尚尚未未未未生生生生产产产产过过过过的的的的药药药药品品品品。已已已已生生生生产产产产的的的的药药药药品品品品改改改改变变变变剂剂剂剂型型型型、改改改改变变变变给给给给药药药药途途途途径径径径、增增增增加加加加新新新新的的的的适适适适应应应应证证证证或或或或制制制制成成成成新新新新的的的的复方制剂，亦按新药管理复方制剂
26、，亦按新药管理复方制剂，亦按新药管理复方制剂，亦按新药管理。Pharmacology and the Research and Development (R&D) of New DrugPharmacology and the Research and Development of New Drug (R&D)1. Preclinical testing 临床前研究临床前研究临床前研究临床前研究2. Approval for clinical testing 临床研究审批临床研究审批临床研究审批临床研究审批3. Clinical testing (clinical pharmacology)
27、临临临临床床床床试试试试验（临床药理学）验（临床药理学）验（临床药理学）验（临床药理学）4. Approval for production and marketing 生生生生产产产产和和和和销售审批销售审批销售审批销售审批Pharmacology and the Research and Development (R&D) of New Drug1. Preclinical testing Efficacy Efficacy 有效性有效性有效性有效性 (screening and evaluation by (screening and evaluation by pharmacologi
28、cal methods)pharmacological methods) Safety Safety 安全性安全性安全性安全性 (evaluation by toxicological (evaluation by toxicological methods)methods) Quantity Quantity 质量可控性质量可控性质量可控性质量可控性 (pharmacy)(pharmacy) good laboratory practice（GLP）Pharmacology and the Research and Development (R&D) of New Drug2. Clinic
29、al testing Phase I, II, III & IVPhase I, II, III & IV Efficacy Efficacy 疗效疗效疗效疗效 (therapeutic effects)(therapeutic effects) SafetySafety 安全性安全性安全性安全性 (adverse effects)(adverse effects) PharmacokineticsPharmacokinetics 药动学药动学药动学药动学 (PK parameter or (PK parameter or bioavaibility)bioavaibility) good clinical practice (GCP)The phases of drug development 新药研究分期新药研究分期新药研究分期新药研究分期
