Post on 03-Jun-2018
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Herbal drugs/ Pharmaceuticals
Problems and Prognosis
Dr. P. Pushpangadan
Director, National Botanical Research Institute
Lucknow, India
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Growing popularity
5 trillion $ 2020
200562 billion $
Business standard, 2005
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ccessible
ffordable
ssured safety
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About 70% Indian population (60-70crore) depends on alternative systemof medicine.
WHO
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Herbal drugs are
cheaper than generic
drugs ??
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Herbal drugs
have beenused in Indiafor more than
4000 years.
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Allopathy orModernMedicine
Glamorized discipline
Pursued by most (influenced and so called
Literate) in India and, in western countries
Backed by technological advances -
investigations
Based on soundscientific reasoning
experimental evidence; not anecdotal Thus, Modern Medicine is an evidence-
based, techno-savvy science that seems to
provide ultimate care to sick patients
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Allopathy orModernMedicine
But????
The treatment is often symptomatic, costly,
out of reach of most in developingcountries
Exceptfor infective pathologies, we do not
have much to offer except palliation Treatment of Chronic Lifestyle Disorders like
neurodegenerative disorders is often very
disappointing and limited by adverse events
It treats the Disease (symptomatic) and not
the patient as a whole (Holistic approach)
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Therapeutic Objective
The ultimate goal of every physician is to
CURE the disease.
Has Allopathy achieved this goal for all
ailments? No;Except for infective pathologies, we do not
achieve CURE
Most often the treatment is Symptomatic and
Palliative.
Effective & Safe Medicine
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Drug Discoveryproblems
It is notoriously inefficient
One in a hundred thousand or more compounds will
enter the market as a drug
Pharma majors have NO interest in higher plantsextracts for screening for biological activity
In NAPRALERT ethnomedical reports for 14,300
species (5.2% of all plant species) are there;
But 58% of these species have never been examined
biologically or chemically
Of these 74% are used in a manner which parallels
their ethnomedical use
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Traditional medicine
Modern scienceModern medicine
Golden triangle
Thus making cheaper affordable and safe medicine
Mashelkar 2005
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Comp ound Plant Species
Acetyl digoxin Digitalis lanata
Ajmalicine Catharanthus roseus, Rauwolfia sp.
Ajmmaline Rauvolfia serpentina
Andrographolide Andrographis paniculata
Artemissine Artemisia annua
Asiaticoside Centella asiatica
Berberine Berberis spp.
Caffeine Camellia sinensis
Caffeine Camellia sinensis
Cocaine Erythroxylum cocoa
Codeine Papaver spp.
Codiene Papaver somniferum
Colchicine Colchicum autumnale, Gloriosa superba
Curcumin Curcuma longa
Digitoxin, Digoxin, Digitoxigenin Digitalis spp.
Emetine Cephaelis ipecacuanha
Ephedrine Ephedra gerardiana
Ergometrine, Ergotamine, Ergotoxin Claviceps purpurea on Rye plants
Glycyrrhizin, Glycyrrhizinic acid Glycyrrhiza glabra
Hesperidin Citrus spp. Mentha spp.
Examples of some important plant derived drugs
Contd..
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Hyoscine Duboisia spp.
Hyoscyamine Datura spp, Hyscyamus spp.
L-Dopa Mucuna pruriens
Menthol Mentha spp.
Morphine Papaver spp.
Papain Carica papaya
Podophyliotoxin Podophyllum emodi
Quinine, Quinidine Cinchona spp.
Reserpine & Deserpidine Rauvolfia serpentina,
Rutin Eucalyptus spp, Fagopyrum spp, Sophora japonica
Scopolamin Datura sp.
Sennosides A&B Cassia angustifolia, C. acutifolia
Silymarin Silybum marianum
Strychnine Strychnos nux-vomica
Taxol Taxus baccata
Thymol Thymus vulgaris
Vinblastine, Vincristine Catharanthus roseusXanthotoxin Ammi majus, Heracleum candicans
Chemical Intermediates
Citral Lemon grass
Diosgenin Dioscorea spp. Costus spp.
Phytosterols (Stigmasterol & Sitosterol) Soya & Calabar Beans
Solasodine Solanum
Hypercin, Hyperforin Hypericum perforatum
Examples of some important plant derived drugs(Contd..)
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Traditional medicine
Historical background Earliest recorded use of a medicinal plant has
been mentioned in Rigveda
one mentioned in the modern texts is that of the
herb called Ma huang a species of Ephedraused medicinally in China for over 5000 years
Cinchona was used by local south American
tribes long before before the isolation of quinine
for treating malaria Source of aspirin (Salix officinalis) was used as
pain killer for long time before being identified
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Traditional medicines
Middle of 19thcentury, 80% of all medicineswere herbal
Even today 25% of drugs are derived from
plant source Most of these drugs came from traditional
lead, folk knowledge etc.
Some of these still could not substituted
despite the enormous advancement insynthetic chemistry eg. Reserpine, taxol,vincristine etc.
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Revival of herbal medicine
widespread belief that green medicine is healthier
than synthetic products
leading to rapid spurt of demand for health products
like herbal tea, ginseng and such products of
traditional medicine
So rapidsale of herbal products are staggering 100
billion dollars a year.
After India and China, even the western world has
started working on herbals
NIH has set up CAM center and working on St.
Johns wort and Gingko biloba
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Drug development basedon traditional leadsSurvey of traditional remedies
Choice of plant
Identification,authentication
CollectionTraditional formulation
Clinicaltrial
Relatedspecies
Extraction
Biologicalscreening
Effective
1. Analyticalstandard
2. Safety
3. ModerniseTechnology
4. New DosageForms
Active
Bioassay Linked Fractionation
Active Compound(s) Characterisation
Pure Compound, Standardised Extracts
Clinical Trials
CommercialProduction
Marketing
1. Pharmacology2. Toxicity3. Clinical Pharmacology
Bio-availability
RegistrationPharmacokinetics/Pharmacodynamics
Pilot Plant Production
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Reverse pharmacology
What is required is Scientific evidence
Answer lies in providing scientific validation
for efficacy and safety
Screening based on ethnomedical andethnobotanical lead as chances of hitting the
target is more
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System biology
The health triangle. The survival potential of all living systems, H, is expressed in the health
triangle, structured with lifes common denominator: Intelligence, Energy and Organization.
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Synergy
Most of the effective phytomedicine in market areas whole extracts of plants
Practitioners believe that synergistic interactionsbetween the components of individual or mixture
of herbs are a vital part of therapeutic efficacy Mechanism of action of many phytomedicine is
still unknown and there are several instancewhere total extract shows better activity than an
equalent dose of isolated compound chemical and pharmacological evidence to
demonstrate conclusively the concept ofsynergism
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Multi-target approach
Combinations of herbs are normal and arebased on empirical observation andreasoning based on a particular patient
these herbal combinations may not betargeted to a particular organ (multi-targeted),cell, tissue or any biochemical system,making this synergy even more difficult toidentify
possibility of drug interactions and theadverse reactions arising out of these have tobe checked before coming out with the drug
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Plant A
Plant B
Plant CPlant D
Plant E
Plant F
Plant G
Plant H
Pain,
Cartilage
Inflammation
Oxidative stress
Osteoporosis
Anabolic
CNS
Immunomodulator
AntistressBioavailability
Lubricant
Multiple Targets Need A Combo
Activity Matrix: Systems-Biology Approach
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Pharmacovigilance
Any thing herbal is safe!!?????
Adverse drug reactions (ADR)
Drug-drug interactions
Herb-Drug interactions
Toxicity of the isolated ingredients
Traditional process (Shodhana)
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Traditional Medicine: Threats
Poor positioning on a global level
Ignored by the global scientific community
Very little scientific research validations
Very little publications in peer-reviewed
science Journals
Deliberate negative propagandas
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Traditional medicine: Future
Innovative, Effective and
Aggressive use of EmergingTechnologies without
Compromising the BasicPrinciples will be the main key
towards the bright future
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Pharmacological studies
Extraction and fractionation
Activity guided isolation of active copounds
Traditional Approach Selection of potential plants
Formulation and Doasge studiesToxicity stuides Standardization of the formulation(s)
Clinical studies
IPR
Final Product Global Market
Drug Discovery
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