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TranslationalResearchonBotanicals
SECONDEDITION
SchoolofNaturalProductStudies,DepartmentofPharmaceuticalTechnology,JadavpurUniversity,Kolkata,India
Elsevier
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Notices
Knowledgeandbestpracticeinthisfieldareconstantlychanging.Asnewresearchandexperiencebroadenour understanding,changesinresearchmethods,professionalpractices,ormedicaltreatmentmaybecome necessary.
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SayeedAhmad BioactiveNaturalProductLaboratory, DepartmentofPharmacognosy&Phytochemistry,Schoolof PharmaceuticalEducation&Research,JamiaHamdard, NewDelhi,India
MuhammadTayyabAkhtar InstituteofIndustrial Biotechnology,GovernmentCollegeUniversity,Lahore, Pakistan
MdJahangirAlam DepartmentofBiotechnology,National InstituteofPharmaceuticalEducationandResearch(NIPER), Guwahati,Assam,India
AtharAta DepartmentofChemistry,RichardsonCollegefor theEnvironmentalandScienceComplex,TheUniversityof Winnipeg,Winnipeg,Manitoba,Canada
ShivBahadur InstituteofPharmaceuticalResearch,GLA University,Mathura,India
RajibBandyoypadhyay DepartmentofInstrumentationand ElectronicsEngineering,JadavpurUniversity,Kolkata,India
RupeshBanerjee InstituteofBioresourcesandSustainable Development,Takyelpat,Imphal,India
SanjayK.Banerjee DepartmentofBiotechnology,National InstituteofPharmaceuticalEducationandResearch(NIPER), Guwahati,Assam,India
SubhadipBanerjee SchoolofNaturalProductStudies, DepartmentofPharmaceuticalTechnology,Jadavpur University,Kolkata,WestBengal,India
KrzysztofB.Bec InstituteofAnalyticalChemistryand Radiochemistry,CentrumforChemistryandBiomedicine, UniversityofInnsbruck,Innsbruck,Austria
SayantanBera J.B.RoyStateAyurvedicMedicalCollege& Hospital,DepartmentofHealth&FamilyWelfare, GovernmentofWestBengal,Kolkata,India
SantanuBhadra EliLillyServicesIndiaPvt.Ltd.,Bengaluru, Karnataka,India
PardeepK.Bhardwaj InstituteofBioresourcesand SustainableDevelopment(IBSD),Departmentof Biotechnology,MinistryofScienceandTechnology, GovernmentofIndia,Takyelpat,Imphal,Manipur,India
SayanBiswas InstituteofBioresourcesandSustainable Development(IBSD),DepartmentofBiotechnology,Ministry ofScienceandTechnology,GovernmentofIndia,Takyelpat, Imphal,Manipur,India
AnthonyBooker CentreforPharmacognosyand Phytotherapy/ResearchClusterBiodiversityand Medicines,UCLSchoolofPharmacy;ResearchCentrefor OptimalHealth,SchoolofLifeSciences,Universityof Westminster,London,UnitedKingdom
RainerW.Bussmann InstituteofBotany,Departmentof Ethnobotany,IliaStateUniversity,Tbilisi,Georgia EnginCelep FacultyofPharmacy,Departmentof PharmacognosyandPhytotherapy,YeditepeUniversity, Istanbul,Turkey
HluphekaP.Chabalala IKSBasedTechnologyInnovations, DepartmentofScienceandInnovation,Pretoria, SouthAfrica
JoydebChanda InstituteofBioresourcesandSustainable Development,Takyelpat,Imphal,Manipur,India
RawiwanCharoensup MedicinalPlantsInnovationCenterof MaeFahLuangUniversity;SchoolofIntegrativeMedicine, MaeFahLuangUniversity,ChiangRai,Thailand
DebprasadChattopadhyay ICMR-NationalInstituteof CholeraandEntericDiseasesVirusResearchLaboratory,I.D. &B.G.Hospital,Kolkata,WestBengal;ICMR-National InstituteofTraditionalMedicine(ICMR-NITM),Belagavi, Karnataka,India
SushilK.Chaudhary InstituteofBioresourcesand SustainableDevelopment(IBSD),Departmentof Biotechnology,MinistryofScienceandTechnology, GovernmentofIndia,Takyelpat,Imphal,Manipur,India
AnaL.Chávez-Hernández DIFACQUIMResearchGroup, DepartmentofPharmacy,SchoolofChemistry,National AutonomousUniversityofMexico,MexicoCity,Mexico
Wai-IChik SchoolofChineseMedicine,HongKongBaptist University,HongKongSAR,China
IrenaMariaChoma DepartmentofChromatography,Faculty ofChemistry,MariaCurie-SkłodowskaUniversity,Lublin, Poland
SørenBrøggerChristensen DepartmentofDrugDesignand Pharmacology,UniversityofCopenhagen,Copenhagen Ø, Denmark
GeoffreyA.Cordell NaturalProductsInc.,Evanston,IL; DepartmentofPharmaceutics,CollegeofPharmacy, UniversityofFlorida,Gainesville,FL,UnitedStates
Sharna-kayDaley NaturalProductsInc.,Evanston,IL, UnitedStates
BhaskarDas SchoolofNaturalProductStudies,Department ofPharmaceuticalTechnology,JadavpurUniversity,Kolkata, WestBengal,India
JaydeepDas IndianInstituteofTechnology,Bombay, India
BarunDasGupta SchoolofNaturalProductStudies, DepartmentofPharmaceuticalTechnology,Jadavpur University,Kolkata,WestBengal,India
BarshaDassarma DepartmentofPharmacology,Schoolof Medicine,FacultyofHealthSciences,UniversityoftheFree State,Bloemfontein,SouthAfrica
SudarshanaGhoshDastidar DepartmentofInstrumentation andElectronicsEngineering,JadavpurUniversity,Kolkata, India
HugoJ.deBoer NaturalHistoryMuseum,UniversityofOslo, Oslo,Norway
IndiraDevi InstituteofBioresourcesandSustainable Development,Takyelpat,Imphal,India
ThidaratDuangyod MedicinalPlantsInnovationCenterof MaeFahLuangUniversity;SchoolofIntegrativeMedicine, MaeFahLuangUniversity,ChiangRai,Thailand
ThomasEfferth DepartmentofPharmaceuticalBiology, InstituteofPharmaceuticalandBiomedicalSciences, JohannesGutenbergUniversity,Mainz,Germany
ElenaV.Flisyuk Saint-PetersburgStateChemical PharmaceuticalUniversity,Saint-Petersburg,Russia
E.AlexisFlores-Padilla DIFACQUIMResearchGroup, DepartmentofPharmacy,SchoolofChemistry,National AutonomousUniversityofMexico,MexicoCity,Mexico
DilipGhosh Nutriconnect,Sydney,NSW,Australia
ElviraGille NationalInstituteofResearchandDevelopment forBiologicalSciencesBucuresti/StejarulBiologicalResearch Centre,PiatraNeamt,Romania
L.Gori UnitofEmergencyMedicine,USLCentroToscana, SanGiuseppeHospital,Empoli,Italy
JustynaGrabska InstituteofAnalyticalChemistryand Radiochemistry,CentrumforChemistryandBiomedicine, UniversityofInnsbruck,Innsbruck,Austria
De-anGuo ShanghaiResearchCenterforModernizationof TraditionalChineseMedicine,NationalEngineering LaboratoryforTCMStandardizationTechnology,Shanghai InstituteofMateriaMedica,ChineseAcademyofSciences, Shanghai,China
ArunGupta AyuSwasthPvtLtd.,Faridabad,India
PallabKantiHaldar SchoolofNaturalProductStudies, DepartmentofPharmaceuticalTechnology,Jadavpur University,Kolkata,WestBengal,India
RanjitK.Harwansh InstituteofPharmaceuticalResearch, GLAUniversity,Mathura,India
MichaelHeinrich CentreforPharmacognosyand Phytotherapy/ResearchClusterBiodiversityandMedicines, UCLSchoolofPharmacy,London,UnitedKingdom
PaulHolloway DepartmentofBiology,RichardsonCollege fortheEnvironmentalandScienceComplex,TheUniversity ofWinnipeg,Winnipeg,Manitoba,Canada
ChristianW.Huck InstituteofAnalyticalChemistryand Radiochemistry,CentrumforChemistryandBiomedicine, UniversityofInnsbruck,Innsbruck,Austria
BruceHugman WriterandCommunicationsSpecialist, Oxford,UnitedKingdom
MuhammadJahangir DepartmentofFoodScience& Technology,UniversityofHaripur,KhyberPakhtunkhwa, Pakistan
DeborahJohnston LondonSouthBankUniversity(LSBU), London,UnitedKingdom
AmitKar InstituteofBioresourcesandSustainable Development(IBSD),DepartmentofBiotechnology,Ministry ofScienceandTechnology,GovernmentofIndia,Takyelpat, Imphal,Manipur,India
C.K.Katiyar EmamiLtd.,Kolkata,India
WernerKnoss FederalInstituteforDrugsandMedical Devices,Bonn,Germany
PulokKumarMukherjee InstituteofBioresourcesand SustainableDevelopment(IBSD),Departmentof Biotechnology,MinistryofScienceandTechnology, GovernmentofIndia,Takyelpat,Imphal,Manipur;Schoolof NaturalProductStudies,DepartmentofPharmaceutical Technology,JadavpurUniversity,Kolkata,WestBengal, India
TemitopeO.Lawal DepartmentofPharmacyPractice, CollegeofPharmacy,WHOCollaboratingCentrefor TraditionalMedicine,UniversityofIllinoisatChicago, Chicago,IL,UnitedStates;Departmentof PharmaceuticalMicrobiology,UniversityofIbadan, Ibadan,Nigeria
IrinaMacovei FacultyofPharmacy,GrigoreT.Popa UniversityofMedicineandPharmacy,Iasi,Romania
GailB.Mahady ClinicalPharmacognosyLaboratories, DepartmentofPharmacyPractice,CollegeofPharmacy, PAHO/WHOCollaboratingCentreforTraditional Medicine,UniversityofIllinoisatChicago,Chicago,IL, UnitedStates
AnanyaDasMahapatra ICMR-National InstituteofCholera andEntericDiseasesVirusResearchLaboratory,I.D.& B.G.Hospital,Kolkata,WestBengal,India
KalyanMajumdar DepartmentofInstrumentationand ElectronicsEngineering,JadavpurUniversity,Kolkata, India
MotlalepulaGilbertMatsabisa Departmentof Pharmacology,SchoolofMedicine,FacultyofHealth Sciences,UniversityoftheFreeState,Bloemfontein,South Africa
SubirK.Maulik IndianCouncilofMedicalResearch, MinistryofHealth,NewDelhi,India
JoseL.Medina-Franco DIFACQUIMResearchGroup, DepartmentofPharmacy,SchoolofChemistry,National AutonomousUniversityofMexico,MexicoCity,Mexico F.Menichetti UnitofCardiology,USLCentroToscana,San GiuseppeHospital,Empoli,Italy
IrinaYu.Mikhailovskaya Saint-PetersburgStateChemical PharmaceuticalUniversity,Saint-Petersburg,Russia
AncaMiron FacultyofPharmacy,GrigoreT.PopaUniversity ofMedicineandPharmacy,Iasi,Romania
AchintyaMitra CentralAyurvedaResearchInstitute, CCRAS,MinistryofAYUSH,GovernmentofIndia,Kolkata, India
SonaliMukherjee AYUSHWing,DepartmentofHealth& FamilyWelfare,GovernmentofWestBengal,Swasthya Bhavan,Kolkata,India
LutfunNahar LaboratoryofGrowthRegulators,Instituteof ExperimentalBotanyASCR&PalackýUniversity,Olomouc, CzechRepublic
IgorA.Narkevich Saint-PetersburgStateChemical PharmaceuticalUniversity,Saint-Petersburg,Russia
SaminaNaz DepartmentofChemistry,RichardsonCollege fortheEnvironmentalandScienceComplex,TheUniversity ofWinnipeg,Winnipeg,Manitoba,Canada
NeeleshK.Nema NutraceuticalDivision,CVJCreative Centre,SynthiteIndustriesPvt.Ltd.,Kolenchery,India
HannaNikolaichuk DepartmentofChromatography, FacultyofChemistry,MariaCurie-SkłodowskaUniversity; DepartmentofBioanalytics,FacultyofBiomedicine,Medical UniversityofLublin,Lublin,Poland
Nadire Ozenver DepartmentofPharmacognosy,Facultyof Pharmacy,HacettepeUniversity,Ankara,Turkey; DepartmentofPharmaceuticalBiology,Instituteof PharmaceuticalandBiomedicalSciences,Johannes GutenbergUniversity,Mainz,Germany
PravareePhuneerub MedicinalPlantsInnovationCenterof MaeFahLuangUniversity;SchoolofIntegrativeMedicine, MaeFahLuangUniversity,ChiangRai,Thailand
RittichaiPimpa MedicinalPlantsInnovationCenterofMae FahLuangUniversity;SchoolofIntegrativeMedicine,Mae FahLuangUniversity,ChiangRai,Thailand
OlgaN.Pozharitskaya MurmanskMarineBiologicalInstitute oftheRussianAcademyofSciences(MMBIRAS),Murmansk, Russia
CharuPundir KLEUniversity’sCollegeofPharmacy, Belagavi,Karnataka,India
XueQiao StateKeyLaboratoryofNaturalandBiomimetic Drugs,SchoolofPharmaceuticalSciences,PekingUniversity, Beijing,China
AncuțaCristinaRaclariu-Manolica NaturalHistoryMuseum, UniversityofOslo,Oslo,Norway;StejarulResearchCentrefor BiologicalSciences,NationalInstituteofResearchand DevelopmentforBiologicalSciences,PiatraNeamț,Romania MukhlesurRahman SchoolofHealth,Sportsand Bioscience,UniversityofEastLondon,London, UnitedKingdom
NishikantRaut DepartmentofPharmacyPractice,College ofPharmacy,WHOCollaboratingCentreforTraditional Medicine,UniversityofIllinoisatChicago,Chicago,IL, UnitedStates;DepartmentofPharmaceuticalSciences, RashtrasantTukadojiMaharajNagpurUniversity,Nagpur, India
A.P.Sampieri DepartmentofRadiology,USLCentro Toscana,SanGiuseppeHospital,Empoli,Italy
SatyajitD.Sarker CentreforNaturalProducts Discovery,SchoolofPharmacyandBiomolecularSciences,
LiverpoolJohnMooresUniversity,Liverpool, UnitedKingdom
BilgeSener H.E.J.ResearchInstituteofChemistry, InternationalCenterforChemicalandBiologicalSciences, UniversityofKarachi,Karachi,Pakistan
KhozirahShaari NaturalMedicinesandProductsResearch Laboratory(NaturMeds),InstituteofBioscience,Universiti PutraMalaysia,Serdang,Selangor,Malaysia
AnamAminShami InstituteofIndustrialBiotechnology, GovernmentCollegeUniversity,Lahore,Pakistan
NanaochaSharma InstituteofBioresourcesandSustainable Development(IBSD),DepartmentofBiotechnology,Ministry ofScienceandTechnology,GovernmentofIndia,Takyelpat, Imphal,Manipur,India
AlexanderN.Shikov Saint-PetersburgStateChemical PharmaceuticalUniversity,Saint-Petersburg,Russia
DilipSing DepartmentofInstrumentationandElectronics Engineering,JadavpurUniversity,Kolkata,India
SouadSkalli FacultyofScience,MohammedVUniversityin Rabat,Morocco
Satyajit Tripathy DepartmentofPharmacology,Schoolof Medicine,FacultyofHealthSciences,UniversityoftheFree State,Bloemfontein,SouthAfrica
ShravanKumarUppulapu DepartmentofBiotechnology, NationalInstituteofPharmaceuticalEducationandResearch (NIPER),Guwahati,Assam,India
RoyUpton AmericanHerbalPharmacopoeia,ScottsValley, CA,UnitedStates
S.Vanni UnitofEmergencyMedicine,USLCentroToscana, SanGiuseppeHospital,Empoli,Italy
Prof.Dr.RobertVerpoorte NaturalProductsLaboratory, IBL,LeidenUniversity,Leiden,TheNetherlands
Jia-boWang SchoolofTraditionalChineseMedicine,Capital MedicalUniversity,Beijing,China
MinYe StateKeyLaboratoryofNaturalandBiomimetic Drugs,SchoolofPharmaceuticalSciences,PekingUniversity, Beijing,China
ErdemYesilada FacultyofPharmacy,Departmentof PharmacognosyandPhytotherapy,YeditepeUniversity, Istanbul,Turkey
Hong-JieZhang SchoolofChineseMedicine,HongKong BaptistUniversity,HongKongSAR,China
Chen-LiangZhao SchoolofChineseMedicine,HongKong BaptistUniversity,HongKongSAR;GuizhouUniversity ofTraditionalChineseMedicine,Guiyang, China
Jia-jingZhou StateKeyLaboratoryofNaturaland BiomimeticDrugs,SchoolofPharmaceuticalSciences,Peking University,Beijing,China
Someyearsago,Prof.Pulokaskedmetowritetheforewordforabookheeditedonthevalidationofherbal medicines.Iacceptedthatinvitation,andIwroteabriefdiscussionontheurgentneedforevidence-baseduseof medicinalplants.Now,thereisasecondeditionofthisbook,withcontributionsfromtheauthorsofthefirst editionplus50%morenewcontributions.Also,thistime,partofitisonstudiesaimedatevidence-baseduseof traditionalmedicine,andpartofitisondevelopingnovelleadsfromtraditionalmedicines.Inthepastdecade,the omicstechnologiesandsystemsbiologybecamethekeywordsforbiologicalandmedicinalresearch.Thisgave manynewinsights,forexample,theroleofthegastrointestinaltractmicrobiomeforhumanhealth,andevidence ontheactivityofanumberofmedicinalplants.
Thetoolsoftheomicstechnologiescanbeusedasadouble-edgedswordinmedicinalplantresearch. Transcriptomicsandproteomicswillhelptoidentifythetargetsofactivecompounds.Themetabolomicscanbe usedtoseewhichsignalscorrelatewithactivity.Thisinformationcanthenbeusedtoidentifythecompoundsand seeiftheycouldserveasleadsforfurtherdrugdevelopment.Themetabolomicsinformationcanalsobeusedto defineafingerprintforqualitycontrolofherbalmedicines.Theleadfindingapproachissomethingforthelong term;tofindaleadandeventuallydevelopitintoadrugisa10-to15-yearproject,withestimatedcostsbeing1–2 billioneuros.Theuseofmetabolomicsdataandtheircorrelationwiththebiologicalactivityin invivo testsare immediatelyapplicableforevidence-basedherbalmedicines.Eventually,metabolomicsdatawillbeimportantfor qualitycontrolofherbalmedicines.
Obviously,academicresearchcreatesafoundationonwhichbothnoveldrugsandtraditionalmedicinecanbe furtherdeveloped.Worldwide,somegovernmentsinvestintheresearchoftraditionalmedicine,whereasbig pharmaceuticalindustriesmovetowardthebiologicals.COVID-19showedthat,intheshortterm(withinayear), anovelvaccinecanbebroughttothemarket,whereasanovelcureortreatmentforCOVID-19willtakeat least10years.Shorterperiodswouldbepossiblewitharepurposingapproachinwhichknownregistereddrugs aretestedforotherapplications,likeCOVID-19.Inthatapproach,themajorbottlenecksofdrugdevelopment,i.e., toxicityandsafetystudies,wouldbecircumvented.Moreover,theclinicaltrialscanfullyfocusonactivity,as safetyisalreadyknownfrompreviousregistrationwiththeFDAorEMA.
Becauseofthecomplexityoftraditionalmedicines,theidentificationofthemodeofactionisnottrivial.Multitargetdependentpeffects,antagonists,agonists,synergy,prodrugs,etc.mayallplayaroleinthis.Areductionistapproach withsinglemoleculartargetsisnotthemethodofchoice,becauseofthecomplexityofplantextracts.Modelsfor activityshouldbelivingcellsororganisms.Nowadays,italsoincludesgeneticallymodifiedcellsororganisms inwhichspecificactivitiescanbeeasilymeasured.Clinicaltrials,ofcourse,beingthemostdirectapproach,but whensafetyisnotyetestablished,biologicalactivitycanbestudiedin,animalexperiments,forexample,Zebrafish (Daniorerio), Caenorhabditiselegans,and Artemiasalina.Thissequencegetsgeneticallyfurtherawayfromhumans, butthesemodelsstillshareseveralbasicbiologicalprocesses.Particularly,metabolomicsdataincombinationwith transcriptomicsandproteomicsdatawillbeveryusefultoseetheeffectsofplantextractsonthewholesystem. Finally,aftersafetyhasbeenestablishedbymetabolomics,standardizedpreparationscanbesubjectedtoclinicaltrials. Butweshouldberealistic.Thementionedmethodsarenotpanaceathatsolveallourproblemsandgiveanswersto allourquestions.Theomicstechnologiesareverypowerfulinproducinghugeamountsofdata,infact,morethanwe candealwith.Consequently,inthepastyears,majorprogressinthefieldcamefromnovelchemometricmethodsand artificialintelligence(AI)thatcananalyzelargedatasets.Oneshouldbeverycarefulindealingwiththeresultsand searchforproperwaystovalidatetheoutcomeofourexperiments.Forexample,metabolomicscanidentifyand quantifyallmoleculesinanorganismoracell.Also,largemoleculeslikeproteins,polysaccharides,RNA,and DNAcanbecharacterizedandquantified.Butwhatdoesallthesedatamean?Ifwehaveallthesedataforasingle cell,whycan’twejustputallthesecompoundstogetherinonepot,mixit,andobtainalivingcell?Ofcourse,it raisesthequestion: “Whatislife?” Itismorethanacomplexmixtureofdifferentcompounds;itisanorganized systemthatactsasascaffoldforallkindsoffunctions.Timeandspacearetheframeworkoftheseactivities.
Particularly,physicochemistryisnowneededtofindmodelsthatexplainhowallthesecompoundsareorganizedin differentcellsandcellorganelles,withcellmembranescreatingdifferentcompartmentstoseparatethevariousfunctions.
Thesephilosophicalthoughtsbringmebacktothisbookandparticularlytodrugdevelopment,wherenetwork pharmacologyispresentlyusedasamodeltovisualizeallactivitiesandinteractionsofmedicinesinthehuman “ omes ”.Forallmajormedicines,thetargetshavebeenmappedand,inthenetwork,onecanseewhichtargetsare connectedonthelevelsofgenes,proteins,andmetabolites.Forallmajorailments,onecanseewhatthemajor therapeutictargetsare.Thisisveryusefultoclassifynovelcompounds:dotheyalreadyfitknownclassesordo theyhavedifferentprofilesoftargets,andthuscouldbeanovel,first-in-classdrugwithanewmodeofaction? Moreover,workingwithmedicinalplants,theeffectsofcombinationsofdifferentcompoundscanbevisualized, e.g.,synergy.
Thenetworkisbasedontherapeuticdosesofthedrugs.Inmedicinalplantresearch,manystudiesarenowbasedon thisnetwork,thoughoftenonlyinaqualitativeway.Thegeneralprocedureistofirstfindallcompoundsthathavebeen identifiedinthemedicinalplantofinterest.Thiscanbefrompreviousstudies,aswellasfromcurrentmetabolomics measurements.Thesecondstepistocollectallthedataonthebiologicalactivitiesforallthecompoundsfoundinthe firststep.Subsequently,thesedataarequalitativelyplacedinthenetwork.Basedonthisqualitativesurvey,themost likelymodeofactionoftheherbalmedicineisdeduced.Nowordaboutthelevelsoftheactivecompoundsinthe plant,nocriticalanalysisoftheusedinformation,andnoestimationoftheapproximatedoseapatientgetsofthe medicinalplantandthusoftheactivecompounds.ItislikethemindexperimentsImentionedearlier;justputtingall thedatatogetheronaqualitativebasisdoesnotmeanthatoneunderstandsthelivingsystem.Mostabundantand easy-to-isolatecompoundsfromplantshavebeentestedinavarietyofactivities,andwithoutacriticalanalysisof whatisaphysiological/pharmacologicalreasonabledose,anyplantwillhaveaprofile,alsoforourdailyfood.But theseprofilesarebasedonverylooseground.Apropervalidationofallthedataintroducedinthenetworkis needed,andthesameappliesforthefinalconclusionsfromthenetworkanalysis.
WhydoIgivetheseexamples?Asaneditor,Ialwaysfeelsadtorejectapaper,andasaresearcherIseeallthose metastudiesthatconcernmedicinalplantsandmedicines(e.g.,Cochranereviews)wherealargepartofthepublished studiesisnotconsidered,e.g.,becauseofnotfulfillingbasicrequirementsforagoodclinicaltrial.Alargepartofwhat ispublishedcannotbeusedtodrawanyconclusions.Thatmeansmuchofthepublishedworkdoesnot serveanything.Theymeanalossofprecioustimefortheauthors,aswellasforthecolleagueswhoreadthe papers.Toeventuallyhavesomeimpactasresearchersinacademiaandgovernmentalorganizations,wemustdo better.Weshouldeventuallycomeupwithnoveldrugsorevidence-basedmedicinalplants.Toproducerealevidence, weneedtofollow “goodpractices” rules.
Atthesametime,asIalsomentionedinmyforewordtothefirstedition,thereisanurgentneedforprotectingthe rightsofthedevelopmentofanevidence-basedtraditionalmedicine,justasforanynovelsinglecompoundmedicine. Thepresentpatentlawswillnotacceptthedevelopmentofanexample,traditionalantidiabeticmedicineasan innovation;consequently,whenthatevidencehasbeenobtained,anyonemayusethatinformationandproduce andmarketthemedicine.Inotherwords,thereisaneedforaneconomicincentivefordevelopingtraditionalmedicine.
Inthisbook,thestate-of-the-artresearchofmedicinalplantscanbefound.Itincludes,amongothers,goodpractices, bioassays,systemsbiology,newmethods,regulatoryinstitutions,successfulexamples,etc.IwanttocongratulateProf. PulokK.Mukherjeewiththisexcellentsecondeditionofhowtovalidatetraditionalmedicinesanddevelopnovel leads.Thisbookwillbeofgreatvaluetoteachthenextgenerationofresearchersandtoupdateourcolleaguesall overtheworldaboutthelatestdevelopmentsinmedicinalplantresearch.Forallstakeholders,thisbookisamust tohelpincreasethequalityofresearchinourfieldandtoensurethatnootherpublicationswillberejectedor uncitedbecauseofnothavingtherequiredstandards.
Prof.Dr.RobertVerpoorte
NaturalProductsLaboratory,IBL,LeidenUniversity, Leiden,TheNetherlands
Herbalmedicineplaysanimmenseroleinthemanagementofhumanhealth.Whileitsusageintherapeuticsisbecoming increasinglypopular,traditionalmedicineisstillopentofascinatingrealmsofresearch.Highthroughputscreening-based developmentofsecondarymetabolitesandleadsfromnaturalproductsofferexcitingfrontiersoffutureresearch.The secondeditionofthebook Evidence-BasedValidationofHerbalMedicines bringstogethercurrentthinkingandpractices intheareasofvalidationandevaluationofnaturalproducts.Themainaimofthebookistodescribedifferent approachesandtechniquesforevaluatingthequality,safety,andefficacyofherbalmedicineincludingthemethodsto assesstheactivityofherbalmedicine.Consideringtheculminationoftraditionalandmodernusageofherbal medicine,thisbookhighlightsthetrendsinvalidationandvalueadditionofherbalmedicinewithdifferentscientific approachesusedintherapeutics.
Developmentofnaturalproductsrequiresaconfluenceofmoderntechniquesandintegratedapproachesinvarious fieldsofscienceandtechnology.Thisbookisanefforttobringtogethertheviews,expertise,andexperienceofscientific expertsinthefieldofmedicinalplantresearchanddevelopmentwiththeaimtoshowwhatisexpectedandrequiredfor theevidence-basedvalidationofmedicinalplants.Itcontainsallaspectsofevaluationanddevelopmentofmedicines fromplantsources,includingtheircultivation,collection,phytochemicalandphyto-pharmacologicalevaluation, andtherapeuticpotential.Thus,itwillprovidecurrentcutting-edgescientificresearchonnaturalremedies, discussingseveralaspectsofnaturalproductstoassesstheiractivityandunderlyingmechanismsofaction,witha viewtoimprovestandardsusedindifferentsystemsofmedicine.Emphasisisplacedondescribingthefullrangeof evidence-basedanalyticalandbioanalyticaltechniquesusedtocharacterizenaturalproducts,including omictechnologies,phytochemicalanalysis,hyphenatedtechniques,andmanymore.
Theeditedvolumeprovidesstate-of-the-artreviewsfromresearchersaroundtheworldonvariousaspectsfor evaluationofherbalmedicineandwillhelpresearchersknowabouttheirvalidationtoexploittraditional medicines(TMs)fordrugdiscoveryanddevelopment.Itwillbeaveryusefulpublication,whichwillnotonly serveasahandytoolforstudentsandresearchersinthisareabutwillalsoprovidethemostrecentmethodologies developedforevidence-basedvalidation,andphytochemicalandpharmacologicalevaluationofherbaldrugsin allaspectsleadingtothetranslationalapproaches.Withemerginginterest,thisvolumewillencouragecontinuing effortstounderstandTM-inspireddrugdevelopmentaswellastherolesofTMinglobalhealthcareatlarge.This bookwillimprovealevelofunderstandingofvariousaspectsonevaluationofnaturalproductsandprovidea comprehensivevalidationofherbalmedicine,sothattheycanbeusedwithgreaterconfidence,raisinga scientificallysoundevidencebaserelatingtodifferentaspectsofthetranslationalresearchonbotanicals.
Thisbookismeantforaglobalreadership,aimedatprovidingastructuredapproachtotheevidence-based evaluationofherbsandherb-derivedproducts.Itwillactasanessentialreferenceforanyonewhoseprofessional lifeimpingesontheuseofnaturalresourcesforthoseinvolvedinthefieldsofherbalmedicine,traditionalremedies, pharmaceuticalsciences,andnaturalproductresearch.
Prof.PulokK.Mukherjee InstituteofBioresourcesandSustainableDevelopment (IBSD),DepartmentofBiotechnology, Takyelpat,Imphal,Manipur,India SchoolofNaturalProductStudies, DepartmentofPharmaceuticalTechnology, JadavpurUniversity,Kolkata,India
Theenormousgrowthofherbalmedicinalproductsworldwidehasbeenoneofthemostinterestingaspectsof healthcare.Harmonizationofthedifferentfacetsofdevelopmentofherbalmedicine includingquality,safety, efficacy,validation,andregulation isbestpossiblethroughinternationalcoordination.
Theintentionofthisbookistodescribeandassessvariousapproachesforevidence-basedvalidationofherbal medicine,especiallytranslationalresearchonBotanicals,whichhavebeendescribedindifferentchaptersofthis editedvolumebyeminentscientistsandtechnologistsfromdifferentcountries.Iwouldliketoexpressmygratitude toallofthemfortheirvaluablecontributions.Itwillprovidecurrentcutting-edgescientificresearchonnatural remediesleadingtotranslationalcomponentsofnaturalremedies;anessentialreadforeveryoneinterestedin evidence-basedvalidationofnaturalresources.
IexpressmyheartfeltthankstoProf.RobertVerpoorte,Leiden,theNetherlands,forhissupportand encouragementforallmyworkthroughoutandparticularlyforwritingtheForewordforthisbook.
Itwouldnothavebeenpossibletocompletethisworkwithouttheactivehelpfrommyresearchgroup.Igratefully acknowledgethehelpandsupportrenderedbyDr.AmitKar,Dr.SushilChaudhury,Dr.PallabK.Haldar, Dr.NanaochaSharma,Dr.PardeepBhardwaj,Mr.SubhadipBanerjee,Mr.BhaskarDas,Dr.JoydebChanda, Mr.PradipDebnath,Mrs.SehaSingha,Dr.SayanBiswas,Mr.BarunDasgupta,Mr.RupeshBanerjee,Ms.Akanksha Sharma,Mr.DilipSingh,Mr.ShibuNarayanJana,Mr.SandipanJana,Ms.SuparnaGhosh,andothersfortheir activehelp.
IextremelyappreciatetheinteresttakenbyElsevier,UnitedStates,forproducingthiseditedvolume.Igratefully acknowledgethecooperationandsupportreceivedfromMs.KathrynEryilmaz,Ms.VeronicaSantos,Ms.Swapna Praveen,Mr.TimEslava,andMr.BharatwajVaratharajanfromElsevierinbringingoutthisbook.
Myfather,ShriHariharMukherjee,inspiredmealotinallmyworks,amanIintenselyadmire,andhecontinuesto liveinmyheart.Iamthankfultomyfamily,mymotherMrs.SudhaRaniMukherjee;mybrothersAloke,Tilok,and AmitMukherjee;mywifeDr.KakaliMukherjee;daughterMaria;andsonManishforallthesupportandlovethey givetomealways;youarethereasonbehindmyeverysuccessfulstep.
Prof.PulokK.Mukherjee
InstituteofBioresourcesandSustainableDevelopment (IBSD),DepartmentofBiotechnology,Takyelpat, Imphal,Manipur,India SchoolofNaturalProductStudies, DepartmentofPharmaceuticalTechnology, JadavpurUniversity,Kolkata,India
PulokKumarMukherjeea,b,SubhadipBanerjeeb,BarunDasGuptab, andAmitKara
aInstituteofBioresourcesandSustainableDevelopment(IBSD),DepartmentofBiotechnology,MinistryofScienceand Technology,GovernmentofIndia,Takyelpat,Imphal,Manipur,India bSchoolofNaturalProductStudies,Departmentof PharmaceuticalTechnology,JadavpurUniversity,Kolkata,WestBengal,India
Abbreviations
WHO WorldHealthOrganization
AYUSH Ayurveda,Yoga,Unani,SiddhaandHomeopathy
TM Traditionalmedicine
IUPAC InternationalUnionofPureandAppliedChemistry
USFDA UnitedStatesFoodandDrugAdministration
GACP GoodAgriculturalandCollectionPractices
CDSCO CentralDrugsStandardControlOrganization
CYP450 CytochromeP450
EMEA EuropeanMedicinesAgency
T&CM TraditionalandComplementaryMedicine
1Healthcarethroughherbalmedicine
Herbalmedicinesattracttheinterestofbothpatients andscientists,inallaspectsofdrugdevelopmentfromnaturalproductsandalsoforvalidationoftraditionalmedicine(TM).SeveraldevelopingcountriesrelyonTM becauseoftheiraccessibilityandaffordabilityandscientistsallovertheworldconsiderherbalspeciesasasource fornewchemicalentitiesandusedthemtoisolatecompounds,suchasdigoxin,morphine,taxol,atropineand vinblastine [1].TMhasproventobeaboonfortheimpecuniouswhoaredevoidofthemoderntreatmentfacilities [2].Herbalmedicineshaveanimportantpositioninhealth caresystemsworldwide,theircurrentassessmentand qualitycontrolareamajorbottleneck.Manyadverse eventsofherbalmedicinescanbeattributedtothepoor qualityoftherawmaterialsorthefinishedproducts.Qualityissuesofherbalmedicinescanbeclassifiedintotwocategories,externalandinternal.Externalissuesincludetoxic metals,pesticidesresidues,microbes,adulterationand misidentificationofmedicinalplants.Theinternalissues
affectingthequalityofherbalmedicinesarecomplexity andnon-uniformityoftheingredients.TheIndiansubcontinentisalwaysknownforitsmonumentalwidespreadof medicinallyactiveplants.Duetolargerforestareascoveringmostofthevillagestheadaptivenatureofhumans havehelpedcertainhealthcarepractitionerstochannel thepotentialofnaturalresourcesintopotentmedications [2].TheconceptofAyurvedaisthelivingproofofexperiencebasedtreatmentofdifferentailmentsthroughTM. ManyAyurvedictextsandbookslikeCharakSamhita, SushrutSamhita,AshtangaHridaya,MadhavaNidana, BhavaPrakashaandmanymorehavealwaysboostednaturalproduct-basedhealthcareresearch [3]
Throughtheuseofmodernanalyticalmethodsand pharmaceuticaltechniques,previouslyunsolvedinternal issueshavebecomesolvable [4].Theincreasingsearch fortherapeuticagentsderivedfromplantspeciesisjustifiedbytheemergenceofdiseases.Medicinalplantsserve asmostvaluablesourceforcuringmanydiseases.Herbal medicinesincludeherbalextracts,herbaldrugpreparationsandherbaldrugs.Herbaldrugsareunprocessedpart ofplantsorwholeplants [5].Herbsincludecrudeplant materialsuchasleaves,flowers,fruit,seed,stems,wood, bark,roots,rhizomesorotherplantparts,whichmaybe entire,fragmentedorpowdered.Herbalpreparations includecomminutedorpowderedmaterialsorextracts, tincturesandfattyoilsofherbalmaterials,whichmay beproducedbyextraction,fractionation,purification,concentrationorotherphysicalorbiologicalprocesses [6].
Modernallopathicmedicinehasdevelopedfrom ancientmedicine,anditislikelythatmanyimportant newremedieswasdiscoveredandcommercialized