藥學英語教案

Part1pharmacology

Theword"pharmacology“derivesfromtheGreekwordfordrug,pharmakon.Itisthebranchofmedicineand

biologyconcernedwiththestudyoftheactions,uses,mechanisms,andadverseeffectsofdrugs.Morespecifically,

itisthestudyoftheinteractionsthatoccurbetweenalivingorganismandchemicalsthataffectnormalorabnormal

biochemicalfunction.Ifsubstanceshavemedicinalproperties,theyareconsideredpharmaceuticals.Thefieldof

pharmacologyencompassesdrugcompositionandproperties,interactions,toxicology,therapy,andmedical

applicationsandanti-pathogeniccapabilities.

Thetwomainareasofpharmacologyarepharmacodynamicsandpharmacokinetics.Theformerstudiesthe

effectsofthedrugsonbiologicalsystems,andthelatterstudiestheeffectsofbiologicalsystemsonthedrugs.In

broadterms,pharmacodynamicsdiscussestheinteractionsofchemicalwithbiologicalreceptors,and

pharmacokineticsdiscussestheabsorption,distribution,metabolism,andexcretionofchemicalsfromthebiological

systems.

Pharmacokineticsdescribestheeffectofthebodyonthedrug.Whendescribingthepharmacokinetic

propertiesofadrug,pharmacologistsareofteninterestedinLADME:

?Liberation-disintegration,dispersalanddissolution

?Absorption-Isthemedicationabsorbedthroughtheskin,theintestine,ortheoralmucosa

?Distribution-Howdoesitspreadthroughtheorganism?

?Metabolism-Isthemedicationconvertedchemicallyinsidethebodyandintowhichsubstances?Are

theseactive?Couldtheybetoxic?

?Excretion-Isthemedicationeliminatedthroughthebile,urine,breath,orskin?

Pharmacologyisnotsynonymouswithpharmacyandthetwotermsarefrequentlyconfused.Pharmacology

dealswithhowdrugsinteractwithinbiologicalsystemstoaffectfunction.Itisthestudyofdrugs,ofthereactions

ofthebodyanddrugoneachother.Incontrast,pharmacyisabiomedicalscienceconcernedwithpreparation,

dispensing,dosage,andthesafeandeffectiveuseofmedicines.Thestudyofpharmacologyisofferedinmany

universitiesworldwideinprogramsthatdifferfrompharmacyprograms.Studentsofpharmacologyaretrainedas

researchers,studyingtheeffectsofsubstancesinordertobetterunderstandthemechanismswhichmightleadto

newdrugdiscoveries.Whereasapharmacystudentwilleventuallyworkinapharmacydispensingmedicationsor

someotherpositionfocusedonthepatient.

Part2Pharmaceuticalchemistry

Medicinalorpharmaceuticalchemistryisadisciplineattheintersectionofchemistryandpharmacology,and

involvestheidentification,synthesisanddevelopmentofnewchemicalentitiessuitablefortherapeuticuse.The

contentofmedicinalchemistryalsoincludesthestudyofexistingdrugs,theirchemicalstructure,physicaland

chemicalproperties,chemicalstability,biologicalproperties,structure-activityrelationships(SAR),metabolism,

chemicalmechanismofinteractionbetweendrugsandbiologicaltarget,etc.

Thescienceofmedicinalchemistryinvolvesthedesignandsynthesisofnoveldrugs.Therearetwomajor

considerationsthathavetobetakenintoinanydrugdesignproject.Firstofall,drugsinteractwithmolecular

targetsinthebody,andsoitisimportanttochoosethecorrecttargetforthedesiredpharmaceuticaleffect.Itisthen

acaseofdesigningadrugwillinteractaspowerfullyandselectivelyaspossibleforthattarget-anareaof

medicinalchemistryknownaspharmacodynamics,Secondly,adrughastotravelthroughthebodyinorderto

reachitstarget,soitisimportanttodesignthedrugsothatitisabletocarryoutthatjourney.Thisisanareaknown

aspharmacokinetics.

Thechiefroleofthemedicinalchemististodesignandsynthesizethetargetstructuresrequired.Therefore,

themedicinalchemistisanessentialmemberofanydrugdesignteamsinceheorshehastoidentifywhether

proposedtargetstructuresarelikelytobestableandwhethertheycanbesynthesizedornot.

Inmedicinalchemistry,thesearchofleadcompoundanditsstructuralmodificationareimportanttwosteps

forlookingfornewdrugs.Theleaddiscoveryprocessesincluderandomscreening,drugmetabolismstudies,

clinicalobservationsofdrugaction,rationalapproachestoleaddiscoveryandcomputer-assisteddrugdesign

techniques,etc.Manyapproachescanbeusedforoptimizationofleadcompound,suchasleadoptimizationby

pro-drugdesign,bybioisosterism,bysoftdrugorharddrugdesign,byQSARmethod,etc.Computeraideddrug

design(CADD),asophisticdrugdiscoveringtechniques,isatopicareainmodernmedicinalchemistryforthe

discoveryofleadcompoundanditspharmaceuticaldevelopment.

Part3Pharmaceutics

Pharmaceuticsisabranchofpharmacyofstudyinghowtogeteffectiveandstablepharmaceuticaldosage

formswithoutdisturbingitsqualitybythesystematicapproach.Primitively,itisconcernedwiththescientificand

technologicalaspectsofthedesignandmanufactureofdosageforms.Meanwhile,pharmaceuticsisthescienceof

drugdeliverysystemforseekingtheoptimaldrugdeliveryproductordeviceanditssubsequentperformanceinthe

deliveryofthedrugformsfollowingitsadministrationtoapatient.Thestudyinvolvespreparationandstabilityof

suitabledosageforms,designandmanufactureofdosageformsthatovercomethephysiologicbarrierandoptimize

thedrugaction,quantitativecharacterizationofboththedrugconcentration-effectrelationshipandthe

concentration-timerelationshipafterthedrugentersthebodyandevaluatingthedosageregimen,avoidanceand

eliminationofmicroorganismsinthemedicines.

Pharmaceuticsisamultidisciplinaryarea,withsignificantunderpinningsfromsuchbasicscientificdisciplines

asphysicalchemistry,biochemistry,analyticalchemistry,mathematics,chemicalengineering,molecularand

cellularbiology,pharmacology,anatomyandphysiology.IttriestogathertheknowledgeofpharmacyfromChina

towesterncountries,runthroughthewholehistoryofpharmacyandtouchupontheintroductionofthemost

importantpharmacysubjects.

Arguably,itisthemostdiverseofallthesubjectareainpharmaceuticalscienceandencompasses.Specifically,

thestudyincludesthephysicalpharmaceutics(applicationofthebasicphysicalchemistrynecessaryforthe

efficientdesignofdosageforms),biopharmaceutics(studyofrelevantdrugdeliverysystemsandhowdrugsarrive

therefollowingthedrugadministration),drugdosageformsdesignandcompounding,pharmaceuticaltechnology

andpharmaceuticalmicrobiology(avoidanceandeliminationofmicroorganismsinmedicines).Thecoursealso

includesthenewpharmaceuticaltechniquesandnewdosageformssuchastransdermaldrugdeliverysystem,

nanoparticledrugdeliverysystems,traditionalChinesemedicinedrugdeliverysystems,soliddispersiontechnique,

inclusiontechniquesandapplicationtechniquesofnewexcipients.

Pharmaceuticsspecificallyexplainsthemajorconsiderationsinthedesignofdosageforms:Physicochemical

propertiesconsideration-Theabsorptionofthedruginthebodyisstronglydependentontheresolutionproperties

ofthedrug,suchasdegreeofdissociationandspeedofdiffusionofthedrugmolecules.Knowledgeoftheflow

propertiesofliquidsisusefulinsolvingcertainproblemsrelatingtothemanufactureandperformancesolutions

andsemi-solidsasdosageformsintheirownright.Byfarthemajorityofdrugsaresolid(mainlycrystalline)

powdersand,unfortunatelymostofthesehavenumerousadversecharacteristics,themacroscopicpropertiesof

powdersinfluencetheirperformanceofdosageforms.So,thecharacteristicmustbeconsideredduringthedesign

ofmedicinestoenabletheirsatisfactorymanufactureandsubsequentperformanceindosageforms.

Biopharmaceuticalconsideration-Theadministrationrouteofadosageformaffectstheabsorptionrateintothe

body,andtherapeuticconsiderationsofthediseasestatetobetreated,whichinturnindecidethemostsuitabletype

ofdosageform,possibleroutesofadministrationandthemostsuitabledurationofactionanddosefrequencyfor

thedrug.Thefactorsinfluencingthebioavailabilityofadrugandmethodsofitsassessmentaredescribed.Itis

concernedwithaconsiderationofthemannerinwhichthefrequencyofdrugadministrationandtherateatwhichit

isreleasedaffectitsconcentrationinthebloodplasmaatanygiventime.Microbiologyconsideration——Itis

necessarytoeliminatemicroorganismsfromtheproductbothbeforeandduringmanufacture.Microbiologyisa

verywide-rangingsubject.Pharmaceuticsconcentratesonlyonthoseaspectsofmicrobiologythataredirectly

relevanttothedesign,productionanddistributionofdosageforms.Thismainlyinvolvesavoiding(asepsis)and

eliminating(sterilization)themicroorganisminmedicines,andpreventingthegrowthofanymicroorganismwhich

mightentertheproductduringmanufacture,storageanduseofthemedicine.Theprinciplesandtechniquesof

sterilizationarediscussedinpharmaceutics.

Pharmaceuticswillalsotellusaboutthedevelopmentofpharmacy,theresponsibilityandmissionofa

pharmaceuticalpractitionerandthedirectiontopharmacyprofessionalsubjects.Thecoursefitsallstudentswho

majorpharmacyandteachthestudentshowtomastertheirprofessionstudy.Havinggatheredthisunderstandingof

thebasicsofpharmaceutics,theformulationscientistshouldnowbeequippedtobeginaconsiderationofthe

designandmanufactureofthemostsuitabledosageformforthedruginquestion.

Part4Druganalysis

Druganalysishasevolvedfromatechniqueofthe20thcenturyintoanever-maturingscience-thescienceof

pharmaceuticalanalysis.Byutilizingthemethodologiesandtechniquesinphysics,chemistry,biologyand

microbiology,pharmaceuticalanalysisfocusesonqualitativeandquantitativeanalysisofdrugs,qualitycontroland

developmentofnewdrugs.Thissciencerelatestoawiderangeofstudies,includingqualitycontrol,clinical

pharmacy,analysisoftraditionalChinesemedicineandnaturaldrugs,drugmetabolicanalysis,forensic

toxicologicalanalysis,dopingcontrolandformulationanalysis,etc.

Pharmaceuticalscienceassumesthemostimportanttaskindrugqualitycontrol,whichinvolvesphysicaland

chemicalinspectionoffinisheddrugs,qualitycontrolindrugproduction,qualityobservationinstorage,quick

analysisofpreparationsformulatedinhospitals,establishmentofqualitystandardsintheR&Dofnoveldrugsas

wellastheanalysisofdrugsinvivo.

Inthefirstaspect,itrelatestophysicalandchemicaltesting,throughwhichitispossibletojudgewhetherthe

drugisincompliancewiththequalitystandardsbeforebeingmarketedandused.Duringdrugproduction,raw

material,intermediateandby-productsshouldbeanalyzedandmonitoredtoensurethequalityofthefinalproducts.

Qualityexaminationshouldbeperformedondrugsinstorageonaregularbasissothatappropriatestorage

conditionsandmethodscanbeemployedtoguaranteethestabilityofthedrugsinstorageanduse.Techniquesof

pharmaceuticalanalysisarealsoneededinquickanalysisofthepreparationsformulatedinhospitalstosafeguard

theirquality.

Inthesecondaspect,apartfromthestudiesonsynthesizingroute,pharmacologyandtoxicologyaswellas

drugmanufacturingtechnologies,studiesonqualitystandardsandstabilityareneverthelessnecessaryinthe

developmentofnewdrug.Basedonthechemicalstructures,physicochemicalpropertiesandthepotentialnegative

impactsonquality,itispossibletodesignmethodsfortheidentificationofcounterfeitmedicines,puritytestand

contentassayandtoestablishqualitystandardsfornewdrugs.

Furthermore,inpharmacokinetics,bioavailabilitytestofpreparations,clinicalpharmacologyandclinical

monitoringandadjustmentofplasmaconcentration,methodsandmeansofdruganalysisarealsoneededto

conductqualitativeandquantitativeanalysisofdrugsinblood,tissuesandorgans,tounderstandin-vivoabsorption,

distribution,metabolismandexcretionofdrugs,andtoinvestigatecharacteristicsandmechanismsofaction,

therebyprovidingnecessaryinformationforrationaldruguse,detectionofactivemetabolitesanddiscoveryoflead

compounds.

Thusitcanbeseenthatthemethodsandmeansofpharmaceuticalanalysisareindispensableinthe

development,production,storage,supplyandapplicationofdrugsaswellasclinicalmonitoringofplasma

concentration.Withthevigorousdevelopmentofpharmaceuticalsciences,thescienceofpharmaceuticalanalysisis

facingincreasingchallengesfromvariousrelatedsciences.Insteadofbeingonlylimitedtostaticqualitycontrolof

drugs,ithasdevelopedintoacomprehensiveanddynamicanalyticalstudyondrugmanufacturing,in-vivo

dynamicsandmetabolism.

Part5Pharmacognosy

Theword"pharmacognosy“isderivedfromtheGreekwords“pharmakon”(drug),and“gonsis”or

“knowledge".

Pharmacognosyisastudyofdrugsthatoriginateintheplantandanimalkingdoms.Modemaspectsofthe

scienceincludenotonlythecrudedrugsbutalsotheirnaturalderivatives.Digitalisleafanditsisolatedglycoside,

digitoxin;rauwolfiarootanditspurifiedalkaloid,reserpine;andthyroidglandwithitsextractedhormone,thyroxin；

areallpartofthesubjectmatterofpharmacognosy.

Inabroadsense,pharmacognosyembracesknowledgeofthehistory,distribution,cultivation,collection,

selection,preparation,commerce,identification,evaluation,preservation,anduseofdrugsandeconomic

substancesthataffectthehealthofhumansandotheranimals.Sucheconomicsubstancesextendbeyondthe

categoryofcrudeandtheirderivativestoincludeavarietyofcommercialandmedicinalproductsoftenrequiring

complicatedmethodsofpreparation:allergens,allergenicextracts,antibiotics,immunizingbiologies,flavoring

agents,andcondiments.Inarestrictedsense,thedefinitiononpharmacognosyimpliesaparticularknowledgeof

methodsofidentificationandevaluationofdrugs.

Part6Biopharmacy

Biopharmacyisthestudyofbiopharmaceuticalsofthosemedicaldrugsproducedwiththeaidifbiotechnology

orderivedfromlifeforms.Theseincludeproteinsandnucleicacidsthatareusedfortherapeuticpurposesamong

others.Thetermbiopharmacologydescribesafieldofresearchcloselyrelatedtopharmacokinetics,sometimes

calledbiopharmacy.

Biopharmaceuticalsaremedicaldrugsproducedusingbiotechnology.Theyareproteins(includingantibodies),

nucleicacids(DNA,RNAorantisenseoligonucleotides)usedfortherapeuticorinvivodiagnosticpurposes,and

areproducedbymeansotherthandirectextractionfromanative(non-engineered)biologicalsource.Thefirstsuch

substanceapprovedfortherapeuticusewasbiosynthetic"human5insulinmadeviarecombinantDNAtechnology.

Thelargemajorityofbiopharmaceuticalproductsarepharmaceuticalsthatarederivedfromlifeforms.Small

moleculedrugsarenottypicallyregardedasbiopharmaceuticalinnaturebytheindustry.

Howevermembersofthepressandthebusinessandthefinancialcommunityoftenextendthedefinitionto

includepharmaceuticalsnotcreatedthroughbiotechnology.Thatis,thetermhasbecomeanoft-usedbuzzwordfor

avarietyofdifferentcompaniesproducingnew,apparentlyhigh-techpharmaceuticalproducts.

Whenabiopharmaceuticalisdeveloped,thecompanywilltypicallyapplyforapatent,whichisagrantfor

exclusivemanufacturingrights.Thisistheprimarymeansbywhichthedeveloperofthedrugcanrecoverthe

investmentcostfordevelopmentofbiopharmaceutical.ThepatentlawsintheUnitedStatesandEuropediffer

somewhatontherequirementsforapatent,withtheEuropeanrequirementsareperceivedasmoredifficultto

satisfy.Thetotalnumberofpatentsgrantedforbiopharmaceuticalshasrisensignificantlysincethe1970s.In1978

thetotalpatentsgrantedwas30.Thishadclimbedto15,600in1995,andby2001therewere34527patent

applications.

WithintheUnitedStates,theFoodAdministration(FDA)exertsstrictcontroloverthecommercialdistribution

ofapharmaceuticalproduct,includingbiopharmaceuticals.Approvalcanrequireseveralyearsofclinicaltrials,

includingtrialswithhumanvolunteers.Evenafterthedrugisreleased,itwillstillbemonitoredforperformance

andsafetyrisks.

Themanufactureofthedrugmustsatisfythe"currentGoodManufacturingPractices^^regulationsoftheFDA.

Theyaretypicallymanufacturedinacleanroomenvironmentwithsetstandardsoftheamountofairborne

particles.

Classificationofbiopharmaceuticals:

Bloodfactors(FactorVIDandIX);

Thrombolyticagents(tissueplasminogenactivator);

Hormones(insulin,glucagon,growthhormone,gonadotrophins);

Hematopoieticgrowthfactors(Erythro