Pharmaceutics - PowerPoint PPT Presentation

View by Category
About This Presentation
Title:

Pharmaceutics

Description:

... 536 drugs and pharmaceutical preparations In 1820, the first USP was published. ... Drug Regulation and Control The federal food, drug, and cosmetic act ... – PowerPoint PPT presentation

Number of Views:191
Avg rating:3.0/5.0
Slides: 86
Provided by: xjg5
Learn more at: http://course.sdu.edu.cn
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Pharmaceutics


1
Pharmaceutics
2
1. Introduction to Drugs and Pharmacy
  1. Heritage of pharmacy
  2. Drug standards (????)
  3. The Pharmacists 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.
  • ??????????????????????????????????

4
  • Emetic (induce vomiting???) and antiemetic
    (prevent vomiting???) drugs
  • Diuretic drugs (increase the flow of urine???)

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

6
  • Drugs may be used to reduce pain, fever,
    thyroid(???) activity, rhinitis(??), insomnia
    (??), 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 (??,??)
  • Glaucoma (???), 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(????)
  • Pharmacologists

10
  • Toxicologists
  • Hematologists(????)
  • Immunologists
  • Endocrinologists(?????)
  • Pathologists(????)
  • 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)-???????
  • ?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 (?????)
  • Castor bean (???)
  • Iron oxide
  • Sodium carbonate
  • Sodium chloride
  • Sulfur
  • Animal excrements (???)

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

18
  • Mortars
  • Pestles (?)
  • 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 (??)
  • Citric acid (???)
  • Oxalic acid (??)
  • Tartaric acid (???)
  • Arsenic acid (??)
  • Identified glycerin

23
  • Invented new methods of preparing calomel (??)and
    benzoic acid (????)
  • Discovered oxygen

24
  • 2) Friedrich Serturner (1783-1841), German
    pharmacist
  • Isolation of morphine from opium(??)
  • 3) Joseph Caventou (1795-1877) and Joseph
    Pelletier (1788-1842)
  • isolation quinine and cinchonine (?????) from
    cinchona and strychnine (???) and brucine (????)
    from nux vomica.

25
2. Drug standards
  • The united states pharmacopeia (??) and the
    national formulary (??????)
  • 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 (??,??),
    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
(No Transcript)
33
  • Standards Set Forth in FDA-Approved New-drug
    applications
  • FDA???????????????

34
  • International Organization for standardization
    (ISO)
  • is an international consortium of representative
    bodies constituted to develop and promote uniform
    or harmonized international standards.
  • ???????????????????,????????????????????????
  • ISO 9000-ISO9004 used in the pharmaceutical
    industry

35
  • 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 ??????????????????????????????????????????????
    ????
  • Internationally recognized quality-management
    system.

36
Drug Regulation and Control
  • The federal food, drug, and cosmetic act (??)of
    1938
  • Comprehensive drug abuse prevention and control
    act of 1970
  • Drug listing act(?????????)
  • of 1972
  • Drug price competition and patent term
    restoration act(?????????????) of 1984
  • Drug product recall

37
Drug Regulation and Control
  • Prescription Drug Marketing Act(??????) of 1987
  • Dietary Supplement Health and Education
    Act(??????????? )of 1994
  • The FDA and the Food and Drug Administration
    Modernization ActFDA?????????????) of 1997
  • Code of Federal Regulations and Federal
    Register(???????????? )
  • Drug product recall

38
????
  • 1)?? (pharmacopoeia)??????????????????????????????
    ?,????????,?????????
  • ?????????
  • 1949?,??????? ?????????,??????

39
  • 1953??,??????531?
  • 1957?????????1953???????
  • 1963??????????1963??,???????,??????1310??

40
  • ????1977??,?1980?1? 1?????
  • ???????1925?
  • ???????????1152?
  • ????773?,??????????????????????????????????

41
  • ????? 1985??,?????????????????????
  • ??????????????????????????????????????????????????
  • ????1990??, 1991?7?1???????
  • ???????1751?
  • ?????????????????????784?

42
  • ????????????????????????????967?
  • ?????????? 1990??????

43
  • ????1995???1996?4?1???????
  • ???????2375?,???920?,???1455?
  • ????????????????????????????
  • 1995?????????????,?????????,????????????
  • ?????????????????,??????????????????

44
  • ????2000??,
  • ???????2691?,???992?,???1699?
  • ??????????????????
  • ???????????????????????
  • ?????????
  • ???????????
  • ???????????????
  • ???????????????

45
  • ????2005?
  • 2005. 7. 1 ??

46
  • 2)??????
  • ???????????????????,??????????????????,??????
    ???????
  • ???????????????????,?????????
  • ??????????????????????????????????????
  • ?????????????????????

47
????????
  • ???????????????????????????,?????????????
  • ????(Over The Counter,??OTC)??????????????????????
    ??,??????????????????

48
??? GMP?GLP?GCP
  • GMP (Good Manufacturing Practice) ??????????
  • GLP (Good Laboratory Practice)
  • ?????????????
  • GCP (Good Clinical Practice)
  • ??????????

49
GMP?????
  • ?
  • ????
  • ??????????

50
GMP?????
1?????????????
2??????????????? ?????
3??????????????
51
GLP
?????????????,?????????????????,???,??????,??
??,??,??,???????????????????????,?????????????
52
GLP?????
  • ???????????? ?????
  • ?

53
GCP
  • ?????????????(?????????)??????????,???????????????
    ??????
  • ??GCP?????????????,??????,???????????????

54
GCP?????
  • ?

55
??????
  •          ???(Pharmaceutics)??????????????????????
    ??????????????

56
????
  • 1.??????????????
  • 2.????????????????????????????????
  • 3.??????????????

57
????
?????????????????????,??????,????(Dosag
e form)?
  • 1. ??

???????????????????????????????
??????????????????????????,??????,????(Prep
erations)?
2. ????
? ????????????? ? ??????????????
3. ????
58
????
  • ? ????
  • ? ????
  • ? ????
  • ? ????

??????
59
????
  • ????????????????,??????????????????????????
    ????????????????,?????????????????

60
?????
  • ? ??????????

? ?????????
? ?????????
? ?????????
? ???????????
? ??????????????
? ???????????????
61
??? ????????
  • ?????
  • ?????
  • ????????
  • ?????
  • ?????
  • ?????

62
?????
?????(industrial pharmaceutics)???????,???????????
??????????????????
63
?????
  • ????
  • ??????????????????????????????
  • ??
  • ????????????????????????

64
?????
  • ?????(physical pharmaceutics)?????????????,???????
    ??????????????????????????????
  • ?????????????????????????????????????????????????
    ???????????????????? ?????

65
????????
  • ????????(polymers in pharmaceutics)???????????????
    ??????????????????????????????????????

66
?????
  • ?????(biopharmaceutics)??????????????????????????,
    ??????????????????????????????????????????????????
    ??????????????

67
?????
  • ?????(pharmacokinetics)????????,??????????????????
    ???????????????,????????????????(???)?????????????
    ????????????????????????

68
?????
  • ?????(clinical pharmaceutics)???????,?????????????
    ??????????????,??(???)????????????????????????????
    ????
  • ??????????????????????????????????????????????
    ???????????????????????????
  • ?????????????????????????,??????????

69
??? ?????DDS
  • ??????????
  • ?????????,???????????

70
?????????
  • ????????????????,?????????????????????????????????
    ???????????

71
????????
  • 1. ?????????????
  • 2. ?????????????
  • 3. ?????????????
  • 4. ???????????
  • 5. ????????

72
?????????(DDS)
  • ??????(drug delivery system,DDS)
  • ???????
  • ????(??????)
  • ??????
  • ??????
  • ???????
  • ??????
  • ??????
  • ??????

73
3. The Pharmacists contemporary role
  • Community pharmacies
  • Patient-care institutions
  • Managed care
  • Home health care
  • Military and government service
  • Academic settings
  • Professional associations
  • Pharmaceutical research and manufacturing industry

74
Community pharmacy
  • Pharmacist plays an active role in
  • the patients use of prescription and
    nonprescription medication,
  • diagnostic agents,
  • durable medical equipment and devices,
  • other health-related products.

75
Hospitals, clinics
  • Pharmacists
  • 1) Manage drug distribution and control systems
  • 2) Provide a variety of clinical services as
  • drug utilization reviews,
  • drug use evaluations,

76
  • therapeutic drug monitoring,(???????)
  • intravenous admixture programs(????????)
  • pharmacokinetic consult service,
  • investigational drug supplies,
  • poison control,
  • drug information.

77
Pharmaceutical Industry
Pharmacist
Drug discovery, Drug analysis and quality
control, Product development and
production, Clinical studies and drug
evaluation, Labeling and drug literature, Marketin
g and sales, Management.
78
  • In government service, pharmacists perform
    professional and administrative functions
  • in the development and implementation of
    pharmaceutical care delivery programs(???????? )
  • in the design and enforcement of regulations
    involving drug distribution and drug quality
    standards.

79
Government service
Military service, Public Health Service, Food
and Drug Administration, Veterans Administration
(??????), Department of Health and Human
Services, Drug Enforcement Administration(????),
National Institutes of Health
80
State and local level
Health department, Family and childrens
services, Drug investigation and regulatory
control, Clinics, other health-care institutions.
81
New positions
Pharmacy benefits managers(??????), Disease
management specialists(?????? ), Drug formulary
managers, Therapeutic outcomes researchers, Drug
utlization review specialists, etc.
82
The mission of Pharmacy
  • The mission of pharmacy is to serve society as
    the profession responsible for the appropriate
    use of medications, devices, and services to
    achieve optimal therapeutic outcomes.
  • ??????????,????????????????????????????

83
Definition of Pharmaceutical care
  • Pharmaceutical care is that component of pharmacy
    practice which entails the direct interaction of
    the pharmacist with the patient for the purpose
    of caring for that patients drug-related needs.
  • ??????????????,???????????,??????????????

84
  • The mission of the pharmacist is to provide
    pharmaceutical care. Pharmaceutical care is the
    direct, responsible provision of
    medication-related care for the purpose of
    achieving definite outcomes that improve a
    patients quality of life.
  • ?????????????????????????????????????,????????????
    ????????

85
  • The successful pharmacy graduate must be
  • A problem solver, capable of adapting to changes
    in health care
  • Able to achieve health outcomes through effective
    medication use that are valued by the health care
    system
  • Able to collaborate with and be a resource to
    physicians, nurses, and other health care team
    members,
  • A committed life-long learner

86
  • Pharmacy Practice Standards
  • The Omnibus Budget Reconsiliation Act
  • ???????)of 1990
  • Code of Ethics for Pharmacists of the
  • American Pharmaceutical Association
  • Code of Ethics of the American
  • Association of Pharmaceutical
  • Scientists

87
Questions
  • 1.What is pharmaceutics? How many branches of
    pharmaceutics ?
  • 2. What is a drug? Give some examples
  • 3. Where do new drugs come from? Give examples.
  • 4. Explain drug standards, pharmacopeia, ISO
  • 5. How do you understand your role as a clinical
    pharmacist?
About PowerShow.com