Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.

1. Standardization
of
Herbal Drug
Presented by:
Anupriya Singh
PhD Scholar
Dept. of Rasa Shastra & Bhaishajya Kalpana
Faculty of Ayurveda
IMS-BHU

2. Herbal Drugs
• Plants or plant parts that have been utilized for the preparation of
phytopharmaceuticals which undergoes number of process such
as harvesting, drying, storage etc.
• It can be in any unorganized form such as oils, resins and gums.
2

3. Phytopharmaceuticals
Phytoconstituents
isolated from the
natural source
Single plant drug
Polyherbal
formulation
O M e
O M e
M e O
O M e
M e O
O M e
3

4. Need for Herbal Drugs
Toxic side effects e.g. drugs of modern medicine
Lack of medicines for many chronic ailments
Most diseases – multifactorial – needs therapeutic
intervention
4

5. Global Herbal Market
Medicinal plants world demand is growing at the rate of 1% annually ($ 610 million) and WHO
has projected that the global herbal market will grow to $5 trillion by 2050.1, 2
Annual sales of herbal medicinal products are approximately $3 billion in Germany, $1.5 billion
in US, $ 3 billion in China and $ 0.8 billion (Rs 35,000 million) in India.3
European Union is the biggest market of Indian medicinal plants with the share 45% of total
herbal market. North America accounts for 11%, Japan 16%, Asian countries 19% and rest of
European Union 4.1%.3
The Indian market is growing at the rate of 15-20% ($150 million), while global herbal market
growing at the rate of 8% per annum.3
5

6. Global Use (%) of Traditional Medicine4,5
Belgium, 31
China, 40
Columbia, 40
USA, 42
Australia, 48
France, 49
India, 70
Canada, 70
UK, 70
Germany, 80
6

7. India’s Strength in Herbal Technology6
Different plant species
45000
Ayurveda, 7000
Unani, 700 Siddha, 600
Modern, 30
7

8. Critical observations about Herbals
False claims
Mistaken use
of wrong
species
Misuse by
healthcare
provider &
consumers
Incorrect
dosing
All herbals
are safe
Interaction
with other
medicine
Adultrated with
other medicine &
potent chemical
substances
Poor quality
formulation
Critical
observations
about
Herbals
8

9. Herbal Medicine: Indian Context
Arteether
Galanthamine
Artemisia annua
Galanthus
waranawii
Callistemon
citrinus
Nitisinone
Tiotropium
Atropa
belladona
Antimalarial
Alzheimer’s disease
Prevents
Accumulation of
toxic bioproducts
kidney and liver
Anti-cholinergic
Bronchodilator
Isolated compound Plant Disease
9

10. Needs of Quality Control
Reduce adulteration with substandard drugs
Proper authentication
Scientific validation of therapeutic claims
To confirm purity, efficacy and safety
Customer satisfaction and confidence
10

11. Problems Encountered for QC & QA
Problems
Encountered
for QC & QA
Storage
condition
In process
variation
Mode of
grinding
Method of
drying
Variation
occur
during Post
harvesting
Chemo typic
variation
Phenotypic
diversity
1. Mode of
extraction
2. Polarity of
solvents
3. Stability of
constituents
Interaction
with other
medicine
11

12.  Adulteration and substitution are now a day’s regarded as the common
malpractice in the trade market of medicinal plants.
 Adulterations also exist in herbal raw material trade due to various
reasons.
 Adulteration in marketed samples is one of the greatest drawbacks in
promotion of herbal products.
 Herbal drugs are considered to be safe and free from any side effects,
but herbal medicines do carry certain risks. It is invariably found that
the adverse effects are not due to the intended herb, but rather due to
the presence of an unintended herb or adulteration.
12

13. How to control it ?
Phytochemical
Standardization
13

14. Standardization
Standardization of herbal drugs refers to “confirmation of its identity and
determination of its quality, purity and detection of nature of adulterant by
various parameters”.
14

15. WHO guidelines for standardization of herbal drugs
15

16. Quality
Evaluation of
Herbal Drugs
• Moisture content
• Extractive value
• Ash value
• Fluorescence Analysis
• Foreign matter
• Qualitative
• Quantitative
• Chromatography
• Heavy metal
• Pesticide residue
• Mycotoxin
• Colour
• Odour
• Taste
• Texture
• Fracture
Microbial
contamination
• Toxicological
• Pharmacological
• Other specific activities
• Bacterial
• Fungal
Macroscopic
Microscopic
• Qualitative
• Quantitative
• Powder studies
• Shape
• Size
• External
• Marking
Parameters for standardization
16

17. Organoleptic evaluation
 Sensed by the organ
 Determination includes :
• Colour
• Odour
• Taste
• Texture
 Authentic specimen, pharmacopeial quality samples
 Simplest & quickest method for identity and purity
17

18.  Macroscopic
• It can be seen by naked eyes includes: Shape, size, texture (any marking
as lenticels on Guduchi stem), fracture.
• It’s a preliminary method of identification.
 Microscopic
• Provide detail of cell structure and arrangement of the cells useful for
differentiating similar species. Ex. Types of stomata, Stomatal index,
Palisade ratio, Vein-islet number.
• Powder study helps to analyse powder characters such as trichomes,
Calcium oxalate crystal etc.
Ensures plants of the required species
Botanical evaluation
18

19.  Moisture contain: Excess of water contain in drug will encourage
microbial growth and drug deterioration.
• Limits for water content should therefore be set for every plant
material.
 Extractive value:
• Less extractive value (water, alcohol and ether soluble) than provided
values of drug indicates addition of exhausted material, adulteration or
incorrect process during drying, storage.
 Ash value:
• Evaluate the amount of present silica, especially in the form of sand &
siliceous earth. Continue…
Physical evaluation
19

20.  Fluorescence Analysis:
• Any drug having fluorescence character can be checked out under UV (254, 365 nm).
 Foreign matter:
• Entirely free from moulds or insects producing toxins
• Other parameters such as viscosity, melting point, solubility, reflective index, particle
size determination, bulk density, hemolytic activity, swelling index, foaming index,
pH values should be under the prescribed limit.
20

21.  Determination of Microbial contamination & Aflatoxins:
• Occur due to poor method of harvesting, cleaning, drying etc.
• Total aerobic microbial/fungal/Enterobacteriaceae counts,
test for E. coli. S. aureus, P. aeruginosa, Shigella and
Salmonella.
Biological evaluation
21

22.  Qualitative determination:
• It represent deferent chemical test which helps in the determination of
the secondary metabolites. Ex. Carbohydrates, proteins etc.
• It is preliminary phytochemical screening method.
 Quantitative determination:
• It represents the amount of active constituent.
 Chromatography:
• It is very important method to determine the presence of secondary
metabolites.
• Its also used for partial purification of tested drugs.
Chemical evaluation
22

23.  Heavy metal determination
• Atomic absorption spectroscopy (AAS), Inductively coupled plasma (ICP)
etc.
• Limits of heavy metals are:
• 5 ppm to 0.01 mg/day for As,
• 10 ppm to 0.02 mg/kg for Pb,
• 0.3 ppm to 0.006 mg/kg for Cd,
• 0.2 ppm to 0.02 mg/kg for Cr,
• 0.2 ppm to 0.02mg/kg for Hg.
23

24. 24
Product became banned due to heavy metal
(exceed the permissible limit)

25. 25

26.  Pesticides residue
• It is any unwanted material which remain on or in food after
they are applied to crops.
26

27. • Plant materials are used throughout the developed and developing country as
home remedies, in over-the-counter drug products and as raw material for the
pharmaceutical industry and they represent a substantial proportion of global
drug market.
• Certain herbs have become popular over the years, but the general public and
media still have a poor understanding of safe and effective use of herbal medicine.
• The assurance of the safety and efficacy of a herbal drug requires monitoring of the
quality of the product from collection through processing to the finished packaged
product.
• The need for standardization of herbals is now very essential, to give the global
acceptance of herbal products as remedies for various diseases and ailments. 27
Discussion

28. Conclusion
28
• The subject of the herbal drug standardization is massively wide and deep.
• There is so much to know and so much seemingly contradictory theories on the
subject of herbal medicines and its relationship with human physiology.
• For the purpose of research work on standardization of herbal formulations, a
profound knowledge of the important herbs found in India and widely used in
Ayurvedic formulation is of utmost importance.
• Environment, climate and growth conditions influence composition, as does the
specific part of the plant and its maturity.

29. References
1. Department of Indian system of medicine and Homeopathy draft national policy 2001; De Smet, 2002.
2. Kokate, C.K., Purohit A.P
. and Gokhale S.B. Pharmacognosy, Nirali Prakashan, Budhawarpeth, Jogeshwari Mandir Lane, Pune, India, 27th Ed., 2005.
3. Bhat S, Sharma N and Maheshwari KK. Status and issues affecting the drugs and pharmaceuticals industry in India, Chemical Industry News, 153, 1998.
4. National Medicinal Plants Board. The Standard For Good Field Collection Practices Of Medicinal Plants. [DOC: NMPB-GFCP-01(FD)]; 2015.
5. World Health Organization . Traditional Medicine; 2013. Accessed from: http://www.who.int/mediacentre/factsheets/2003/fs134/en/.
6. Kamboj VP
. Herbal medicine, Current science, 78(1), 35-39, 2005.
29

30. 30
Thank you!