文档介绍：第四章药品与药品监督管理 Chapter 4 : Drugs,and Drug Administration Chapter 4: Drugs,and Drug Administration ? 1. Definition of drugs; ? 2. The classification of drugs; ? 3. The definition and properties of drug quality; ? 4. Drug administration and drug standards. 第一节药品 Section I: Drugs,Medicine I The definition and properties of drug Definition of drugs ?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症或功能主治、用法、用量的物质,包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。药品( Drug,Medicine ): Definition of drugs in “ The Drug Administration Law of ”? Drugs: refer to those substances used for the prevention prevention , treatment treatment and diagnosis diagnosis of human diseases, and for the intentional regulation of human physiological functions. For which indications indications or actions actions , usage usage and dosage dosage have been established. Including herbal drugs herbal drugs and their preparations preparations , prepared slice of herbal drugs prepared slice of herbal drugs , chemical drugs chemical drugs and their preparations, antibiotics antibiotics , biochemical drugs biochemical drugs , radioactive pharmaceuticals radioactive pharmaceuticals , sera and ines sera and ines , blood products, diagnostic aids diagnostic aids etc. 药品使用目的?、治疗疾病?? ?原料与制剂?传统药与现代药 The difinition of drugs in other countries ? USA : --- The Federal Food, Drug and Cosmetic Act (1)法定美国药典(USP)、法定美国顺势疗法药典(USHP)、法定国家药品集(NF)或其补编中承认的物品; (2)用于诊断、治愈、缓解、治疗或预防人或其它动物疾病的物品; (3)用于影响人或其它动物的身体构造或功能的物品(食品除外); (4)用作( 1)、( 2)、( 3)项所指物品的成分的物品,但不包括医疗用品或其组成、部件或附件