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Pharmaceutics

Pharmaceutics. 1. Introduction to Drugs and Pharmacy. Heritage of pharmacy Drug standards （药品标准） The Pharmacist’s contemporary role. A drug is defined as an agent intended for use in the diagnosis , mitigation , treatment , cure , or prevention of disease in humans or in other animals.

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Pharmaceutics

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  1. Pharmaceutics

  2. 1. Introduction to Drugs and Pharmacy • Heritage of pharmacy • Drug standards （药品标准） • The Pharmacist’s contemporary role

  3. A drug is defined as an agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals. 药物是有目的地用于诊断、缓解、治疗、治愈或预防人类或动物疾病的物质。

  4. Emetic (induce vomiting催吐剂) and antiemetic (prevent vomiting止吐剂) drugs • Diuretic drugs (increase the flow of urine利尿剂)

  5. Expectorant drugs (increase respiratory tract fluid除痰剂) • Cathartics or laxatives (evacuate the bowel泻药) • Other drugs decrease the flow of urine, diminish body secretions, or induce constipation (便秘)

  6. Drugs may be used to reduce pain, fever, thyroid（甲状腺）activity, rhinitis（鼻炎）, insomnia （失眠）, gastric acidity, motion sickness, blood pressure, and mental depression. • Other drugs can elevate mood, blood pressure, or activity of the endocrine glands.

  7. Drugs are used to treat • common infections, • AIDS, • benign prostatic hyperplasia, • cancer, • cardiovascular disease, • Asthma (气喘,哮喘） • Glaucoma （青光眼）, etc.

  8. Where do new drugs come from? New drugs may be derived from • Plant • Animal sources • As byproducts of microbial growth • Through chemical synthesis • Molecular modification • Biotechnology

  9. The process of drug discovery and development • Complex • Organic, physical, and analytical chemists • Biochemists • Molecular biologists • Bacteriologists • Physiologists（生理学家） • Pharmacologists

  10. Toxicologists • Hematologists（血液学家） • Immunologists • Endocrinologists（内分泌学家） • Pathologists（病理学家） • Biostatisticians • Pharmaceutical scientists • Clinical pharmacists • Physicians • Many others

  11. After a potential new drug substance is discovered 1) A great deal of biologic information must be gathered • basic pharmacology • toxicologic features • ADME • short term and long term effects of the drug on various body cells, tissues and organs

  12. 2) The most effective routes of administration must be determined • And Guidelines for dosages recommended for • Persons of varying ages (e.g., neonates, children, adults, geriatrics) • Weights • States of illness • have to be established.

  13. 3) Formulation • Active therapeutic ingredients • Fillers • Thickeners • Solvents • Suspending agents • Tablet coatings • Disintegrants • Stabilizing agents • Antimicrobial preservatives • Flavors • Colorants • sweeteners

  14. 4) Stability • the principles of chemistry, • physical pharmacy, • microbiology, • pharmaceutical technology must be applied.

  15. 1. The Heritage of Pharmacy Early drugs  Ebers papyrus, a continuous scroll (16th century)-埃伯斯纸草文稿 The text of the Ebers papyrus is dominated by drug formulas, with more than 800 formulas or prescriptions being described and more than 700 drugs mentioned.

  16. The drugs are chiefly botanical, although mineral and animal drugs are also noted. • Acacia （阿拉伯树胶） • Castor bean （蓖麻子） • Iron oxide • Sodium carbonate • Sodium chloride • Sulfur • Animal excrements (排泄物）

  17. The vehicles were • Beer • Wine • Milk • honey

  18. Mortars • Pestles (杵) • Hand mills • Sieves • Balances

  19. 2) Introduction of the scientific viewpoint • Hippocrates, a Greek physician, is credited with the introduction of scientific pharmacy and medicine. • He rationalized medicine, systematized medical knowledge, and put the practice of medicine on a high ethical plane.

  20. Dioscorides, a Greek physician and botanist, was the first to deal with botany as an applied science of pharmacy. • Claudius Galen, a Greek pharmacist-physician, aimed to creat a perfect system of physiology, pathology, and treatment.

  21. Paracelsus, a Swiss physician and chemist, he influenced the transformation of pharmacy from a profession based primarily on botanical science to one based on chemical science.

  22. 3) Early research 1) Swede Karl Wilhelm Scheele (1742-1786) • Lactic acid （乳酸） • Citric acid （柠檬酸） • Oxalic acid （草酸） • Tartaric acid （酒石酸） • Arsenic acid （砒霜） • Identified glycerin

  23. Invented new methods of preparing calomel （甘汞）and benzoic acid （安息香酸) • Discovered oxygen

  24. 2) Friedrich Serturner (1783-1841), German pharmacist • Isolation of morphine from opium（鸦片） 3) Joseph Caventou (1795-1877) and Joseph Pelletier (1788-1842) • isolation quinine and cinchonine (弱金鸡钠碱) from cinchona and strychnine （士的宁）and brucine （番木鳖碱）from nux vomica.

  25. 2. Drug standards The united states pharmacopeia (药典) and the national formulary (国家药品标准) • Pharmakon, meaning “drug”; poiein, meaning “make”; • The combination indicates any recipe or formula or other standards required to make or prepare a drug. • Organized sets of monographs or books of these standards are called pharmacopeias or formularies.

  26. In 1778, the first American Pharmacopeia (Lititz Pharmacopeia) was published. • 32-page booklet containing information on 84 internal and 16 external drugs and preparations. In 1808, Massachusetts pharmacopeia • 272 page, 536 drugs and pharmaceutical preparations

  27. In 1820, the first USP was published. • In 1900, issue supplements to the USP • In 1940, it was decided to revise the USP every 5 years

  28. In 1888, National Formulary of Unofficial Preparations was published. • The formulary containing many of the popular drugs and formulas denied admission to the USP. In 1906, the title was changed to National Formulary (NF) • Both USP and NF as establishing legal standards for medicinal and pharmaceutical substances.

  29. In 1980, the first combined compendium (摘要,纲要), comprising the USP XX and NF XV became official. • In 1995, the USP 23-National Formulary 18 was the first edition to drop the use of roman numerals in favor of arabic numerals.

  30. In 2002, the USP-NF became an annual publication with USP 25-NF 20 • The 2003 edition, USP 26-NF 21, contains approximately 4000 drug monographs. • The newest edition 2010, USP 33- NF 28

  31. USP and NF adopt standards for • drug substances • pharmaceutic ingredients • dosage forms reflecting the best in the current practices of medicine and pharmacy • provide suitable tests and assay procedures for demonstrating compliance with these standards.

  32. Standards Set Forth in FDA-Approved New-drug applications FDA批准的新药物的应用的标准中规定

  33. International Organization for standardization (ISO) • is an international consortium of representative bodies constituted to develop and promote uniform or harmonized international standards. • 国际标准化组织是一个代表性的国际联合会，其设立是为了发展和增进国际标准的均一性和协调性。 • ISO 9000-ISO9004 used in the pharmaceutical industry

  34. ISO included standards pertaining to development,production,quality assurance, quality control, detection of defective products, quality management, and other issues as product safety and liability. • ISO 包括标准适合开发、生产、质量保证、质量控制、缺陷产品的检测、质量管理和其他如产品安全性和责任的问题。 • Internationally recognized quality-management system.

  35. Drug Regulation and Control • The federal food, drug, and cosmetic act (条例)of 1938 • Comprehensive drug abuse prevention and control act of 1970 • Drug listing act(药品上市的行为条例) • of 1972 • Drug price competition and patent term restoration act(药品价格竞争和专利期恢复法) of 1984 • Drug product recall

  36. Drug Regulation and Control Prescription Drug Marketing Act(处方药营销法) of 1987 • Dietary Supplement Health and Education Act(膳食补充剂健康与教育法 )of 1994 • The FDA and the Food and Drug Administration Modernization ActFDA和食品和药物管理局现代化法) of 1997 • Code of Federal Regulations and Federal Register(联邦法规和联邦注册的代码 ) • Drug product recall

  37. 中国药典 1)药典 (pharmacopoeia)是一个国家记载药品规格和标准的法典。由国家组织的药典委员会编写，并由政府颁布施行，具有法律的约束力。 中华人民共和国药典 • 1949年，编纂我国第一部 《中华人民共和国药典》，简称《中国药典》；

  38. 1953年版，收载各类药品531种； • 1957年又出版了《中国药典》1953年版第一增补本； • 1963年编纂出版了《中国药典》1963年版，共分一、二两部，收载中西药品1310种。

  39. 《中国药典》1977年版，于1980年1月 1日起施行。 • 共收载中西药品1925种； • 一部收载中药材和中成药1152种； • 二部收载773种，剂型增加了气雾剂、冲剂、滴丸剂、糖丸、耳丸、汤剂、眼药水和滴耳液等。

  40. 《中国药典》 1985年版，本版药典收载的品种其质量标准均有一定的提高： • 药品的理化鉴别增加了薄层扫描法、高效液相层析法、紫外、红外光谱法、荧光分析法和原子吸收分光光度法等。 • 《中国药典》1990年版， 1991年7月1日起颁布施行。 • 共收载中西药品1751种； • 收载中药材、植物油脂、中药成方及单味制剂等784种；

  41. 化学药、生化药、抗生素、放射性药品、生物制品及各类制剂共967种；化学药、生化药、抗生素、放射性药品、生物制品及各类制剂共967种； • 以后又出版了《中国药典》 1990年版增补本。

  42. 《中国药典》1995年版于1996年4月1日起颁布执行。《中国药典》1995年版于1996年4月1日起颁布执行。 • 共收载中西药品2375种，一部为920种，二部为1455种； • 本版药典增加了搽剂、露剂、颗粒剂、口服液和缓释制剂等剂型； • 1995年版药典中的药名有较大变动，一部大多为天然药物，采用国际上通用拉丁文学名； • 二部则取消拉丁文药名而改为英文药名，附录中试药的外文名称亦作了相应修改。

  43. 《中国药典》2000年版, • 共收载中西药品2691种，一部为992种，二部为1699种； • 首次收载药品标准分析方法验证指导原则； • 药物制剂人体生物利用度和生物等效性试验指导原则； • 药物稳定性指导原则； • 缓释、控释制剂指导原则； • 微囊、微球和脂质体制剂指导原则； • 细菌内毒素检查法应用指导原则。

  44. 中国药典2005版 • 2005. 7. 1 施行

  45. 2)国家药品标准 《中华人民共和国药品标准》简称《国家药品标准》，由国家药品监督管理局编纂并颁布实施的，主要包括以下几个方面的药物： • 药品监督管理局审批的国内创新的重大品种，国内未生产的新药。 • 药典收载过而现行版未列入的疗效肯定、国内几省仍在生产、使用并修定标准的药品。 • 疗效肯定、但质量标准仍需进一步改进的新药。

  46. 处方药与非处方药 处方药是必须凭执业医师或执业助理医师处方才可调配、购买，并在医生指导下使用的药品。 非处方药（Over The Counter，简称OTC）是由专家遴选的、不需凭执业医师或执业助理医师处方，患者可以自行判断、购买和使用的药品。

  47. 第六节 GMP、GLP与GCP • GMP (Good Manufacturing Practice) 药品生产质量管理规范 • GLP (Good Laboratory Practice) 药品非临床研究质量管理规范 • GCP (Good Clinical Practice) 药品临床试验管理规范

  48. GMP的检查对象 • 人 • 生产环境 • 药品制剂生产的全过程

  49. GMP的三大要素 1、人为产生的错误减小到最低； 2、防止对医药品的污染和低质量医 药品的产生； 3、保证产品高质量的系统设计。

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