75%-90% of the population in developing nations rely on herbal medicine as their only health care. Medicinal herbs are sold alongside vegetables in village markets. Practitioners of herbal medicine undergo extensive training to learn the plants, their uses, and preparation of remedies.

1. STANDARDISATION OF MEDICINAL
PLANTS - A MULTIDISCIPLINARY
APPROACH
Dr. M.Sankareswaran

2. INTRODUCTION
1495- use of medicinal plants started
7000 medicinal compounds –Caufield 1991
10% has estimated for drugs
85% of medicinal plants used in China
65 % of medicinal plants used in India

3. TRADITIONAL (HERBAL) MEDICINE
TODAY
75%-90% of the population in developing
nations rely on herbal medicine as their only
health care.
Medicinal herbs are sold alongside vegetables
in village markets.
Practitioners of herbal medicine undergo
extensive training to learn the plants, their
uses, and preparation of remedies.

4. 1.75 million known species of animals, plants, fungi,
& micro-organisms.
Estimated to be 10 million species on earth.
Each species contains 100’s - 1,000’s of chemicals.
1 billion - 1 trillion chemicals
Role of Biodiversity in Medicine

5. INDIA
Traditional systems separate from Western
medicine.
At universities medical students are trained
in Western medicine.
Most people use traditional systems:
Siddha and Ayurvedic medicine - Hindu origin
Unani medicine - Muslim and Greek origin
Economic is also a factor - manufactured
pharmaceuticals too expensive for most

6. Total
10000
species
8000
Medicinal
Edible
Pesticides
Gums, Resins & Dyes
India’s strength in Herbal Technology

7. Analgesics: Aspirin: Salix species/Europe
Morphine, Codeine; Papaver somniferum/
Mesopotamia (Iran, Iraq)
Cardiotonic: Digitalin: Digitalis purpurea/UK-Europe
Malaria: Quinine: Cinchona spp./Amazonia
Artemsinin: Artemisia annua/China
Antihypertensive: Reserpine: Rauwolfia serpentina/India
Memory enhancement: Physostigmine: Physostigma
venenosum/West Africa
Muscle relaxant: Tubocurarine: Chondrodendron spp./
Plant-derived Drugs

8. Aegle marmelos Azadirachta indica

9. Gymnema sylvestre
Aloe vera

10. Centella asiatica
Coleus ambonicus

11. Phyllanthus emblica
Eclipto alba

12. Adothoda vasica Solanum trilobatum

13. Vetiveria zizanioide
Ocimum sanctum

14. METHODOLOGY
STANDARDISATION OF PLANT
MEDICINE
Environmental factor- Too see soil, temperature, ph, water
activity.
Physiological factor- seed, drying, packing, age, storage,
collection etc.
Morphological factor- taxonomical, classification,
identification etc.
Formulatory factor- proper documentation, stability, efficacy,
liquid, solid or various preparations.
Cont...

15. Analytical factor- raw materials, heavy materials, toxins,
mycotoxin etc.
Chemical factor- ash, solvent, volatile compounds, loss in
drying, fucibility etc.
Extraction - infusion, decoction, maceration,
percolation, digestion.
Confirmation and purification-TLC, HPLC,HPTLC,GC-
MS,UV, IR and Mass
spectroscopy
Drug designing- molecular docking studies.

16. MODE OF ACTION OF HERBAL DRUGS
Agonistic
Synergistic
Antagonistic
Complementary
Toxic
Wholistic biological synergism
Need for bioequivalence of herbal drugs.
Hepato protective, immunomodulator- unknown
factor contribute for that.
Chinese use Aloe vera/ soft skin/ having most
infection

17. BIOEQUIVALENCE ASSAY
METHODS
Microbiological assay- antimicrobial and antiviral activity
Pharmacological studies
Pharmaceutical studies
Toxicological studies
Clinical bio reproducibility studies
Invitro or invivo models
By randomised, controlled clinical trials.

18. STANDARDISATION
OF HERBAL DRUGS
Standardization & Quality Evaluation of Herbal
drugs
2

19. Herbal Drug
Formulations
Tablets
Capsules
Oral solutions,
suspensions
and emulsions
Powders and
granules for
oral solution
or suspension
Metered-dose
inhalers and
nasal
aerosols
Nasal
sprays:
Solutions
and
suspensions
Topical,
ophthalmic
and Ear (otic)
preparations
Suppositories
Small volume
parenterals
Large volume
parenterals
Transdermal
patches

20. Separation
Isolation
Identification
Extraction
Crude Extract
Extract Fractions
Pure Compounds
Medicinal plants
Active
Lead Compound
Determination of
Biological Activity

21. Target
selection
Target
to
Lead

23. Sampling/selection of raw material
Preservation of samples / extracts
Extraction of bioactive compounds
Separation & Detection
Critical steps for Extraction

24. EXTRACTION METHODS
Cold aqueous percolation
Hot aqueous extraction (decoction)
Solvent extraction (cold / hot)
Maceration
Infusion
 Digestion
Decoction

25. PRELIMINARY ASSESSMENT OF
PHYTOCHEMICAL ANALYSIS
Preliminary Phytochemical Screening
• Test for alkaloids
• Test for proteins and free amino acids
• Tests for anthraquinone glycosides
• Test for tannin and phenolic compounds
• Test for carbohydrates
• Test for saponins
• Test for phytosterol
• Test for triterpenes

26. Preliminary Assessment of
Antimicrobial Activity
Parasite
 Broth dilution
method
Viral
 Kit method
Fungal
Well Diffusion method
Verpoortea et al-1982
Bacterial
 Disc Diffusion method
 Bauer et al-1996

27. ?
Active
Compound
Determine
Molecular Structure
=

28. CHROMATOGRAPHY
- BASIC REQUIREMENTS
Stationary Phase
paper, glass, plastic, gel
Mobile Phase
water, other solvent

29. Herbal
Drug
Evaluation
HPLC
GC
TLC
UV
FTIR
GC-MS
HPTLC

30. Analytical Techniques
High Performance Liquid
Chromatography (HPLC)
Gas Chromatography (GC)
Thin Layer Chromatography (TLC)

31. Analytical techniques
Thin Layer
Chromatography (TLC)
•Very sensitive, rapid, very
accurate for the natural
products
High Performance Liquid
Chromatography (HPLC)
Gas Chromatography (GC)

32. Structure Elucidation

33. NMR is the most powerful
tool available for organic
structure determination.
Variety of nuclei:
• 1H 13C 15N 19F 31P
Identification by Nuclear Magnetic
Resonance (NMR) Spectra

34. FROM PLANT TO DRUG
O
O
OH
OH
OH
OH
HO
O
OH
OH
OH
Plant Crude
Extract
Pure
Compound
Molecular
Structure
Biological Activity
=

35. Plant Crude Extract
Chromatography
Pure
Compound
Extraction
Extraction
Bioassay
Bioassay
Repeat
Bioactivity-Guided Separation

36. Selection of the target bioactive compound from the
identified compounds
Molecular docking studies of the selected identified
the bioactive compound
Selection of
target protein
Preparation of
Ligand
To develop new drug, with computer aided drug designing
bioinformatics tools from the isolated and separated
bioactive compounds

37. MAJOR STAGES OF DRUG DEVELOPMENT
Preclinical Testing
IND Application
Clinical Testing – Phase I
Clinical Testing – Phase II
Clinical Testing – Phase III
New Drug Application
Clinical Testing–Phase IV

38. DRUG DEVELOPMENT PROCESS
Initial
Synthesis
Animal
Testing
I
N
D
A
P
P
L
I
C
A
T
I
O
N
Phase I
Phase II
Phase III
Phase IV
Adverse
Reaction
Reporting
Surveys/
Sampling
Testing
Inspections
Range 1-3 Yrs.
Avg:18 Mos.
IND Time
30 Day
Safety Review
Range 2-10 Yrs.
Avg: 5 Yrs.
IND
Submitted
IND
Approved
Range 2Mons – 7 Yrs.
Avg:24 Mos.
(1980-1987)
Average of Approximately 100 Months From Initial Synthesis to Approval of IND
Treatment Use
Preclinical Clinical IND Review Post-Marketing

39. FDA
FDA regulations on the traditional herbal medicine are
another area of great significance.
Herbal medicine users assume that herbs are natural and
therefore safe, but using herbal medicine has become
dangerous because in many case the doses are unknown.
Often the labels are misleading and they can interfere
with prescription medications, foods and other herbs. All
the herbal remedies need regulating information in its
labels.
The FDA authority should make sure that the label
claims is true.

40. THE WAY RESEARCH IS CONDUCTED ON HERBAL
MEDICINE HAS UNDERGONE MYRIAD CHANGES. THE
AREA THAT HAVE CHANGED INCLUDE;
Botanical verification.
Good agricultural production practice.
Good collection practice.
Evaluation of literature reports with emphasis on review of safety
and efficacy literature.
Phytochemical isolation techniques.
Activity guided structure elucidation- pharmacological and
toxicological evaluation.
Good clinical practice.
Pharmaceutical assessment of the quality safety and efficacy of
herbal medicine. Cont....

41. Synthesis of natural products including retrospective analysis,
biometric synthesis and semi synthesis. Biosynthetic studies and
tissue culture techniques are offering more details of phyto
metabolite formation.
Computational biology and bioinformatics guided drug discovery.
Improving the safety of herbal remedies is a research area gaining
utmost importance. The types of toxic and pathogenic
contaminants of herbal medicine include toxic botanicals,
microorganisms, microbial toxins, pesticide, fumigation agents,
radio activity, toxic metals, synthetic pharmaceuticals and animal
substance.
The academia, government, the herbal industry and the
pharmaceutical industry are working together to develop
practical methods for ensuring the safety of herbal medicine.
Cont....

42. Introducing pharmaco vigilance systems in the siddha
system of medicine is the need of the hour. This step
will strengthen the Indian national capacity in
monitoring the safety of siddha formulations and in
analyzing the cause of adverse events.
Majority of adverse events related to the use of siddha
formulation are attributable either to poor product
quality or to improper use.
To overcome this pitfall we should strengthen the
regulatory measures, quality control system and drug
distribution channels. In addition greater attention
should be given to consumer education.

43. PATENTING
CDRI- LUCKNOW
IPR

44. EFFORTS IN INDIA
ICMR
Traditional medicine testing laboratory- Srinagar
AYUSH