Herbal Drugspharmaceuticals

8/12/2019 Herbal Drugspharmaceuticals

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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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