it explains procedures and need of quality control of herbal drugs

1. QUALITY CONTROL METHODS FOR
HERBAL DRUGS
Presented by:
N VEERARAGHAVULU
Reg.No:17421S0707
M Pharmacy 1st year Ist semester
Department of Pharmaceutical Analysis
Guided by :A. SREENIVASA CHARAN, M. Pharmacy,(Ph.D.)
Assistant professor, Sri padmavathi school of pharmacy
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CONTENTS:-
 INTRODUCTION TO HERBAL MEDICINES
 TRADITIONAL SYSTEM OF MEDICINE IN INDIA
 STANDARDIZATION
 NEED OF STANDARDIZATION
 QUALITY CONTROL METHODS FOR HERBAL DRUGS
 CONCLUSION
 REFERENCES

3.  The basic resources of medicines come from nature and they are used as
medicaments from ancient time to present day.
 The traditional medicines used about 85% of the world population for
their health needs.
 Indian healthcare consists of medical pluralism and Ayurveda still
remains dominant compared to modern medicine, particularly for
treatment of a variety of chronic disease conditions
 It is essential to maintain safety, quality and efficacy of the plant and
their products to avoid and serious health problems
INTRODUCTION TO HERBAL MEDICINES:-
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4.  WHO defines traditional medicine as including diverse health practises,
approaches, knowledge and beliefs incorporating plant, animal and/or
mineral based medicines, spiritual therapies, manual techniques and
exercises applied singularly or in combination to maintain well-being, as
well as to treat, diagnose or prevent illness.
Traditional system of medicine in India:-
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 In Sanskrit, the words Ayurveda consists of the words ayus, meaning
"longevity", and Veda, meaning "related to knowledge" or "science".
 The Susruta Samhita-and the Charaka Samhita-where influential works
on traditional medicine.
Ayurveda:-

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 Siddha system is one of the oldest systems of medicine in India.
 The term Siddha means achievements and Siddhars were saintly persons
who achieved results in medicine.
 This principles and doctrines of this system, both fundamental and
applied, have a close similarity to Ayurveda, with specialization in Iatro-
chemistry.
Siddha:-
Homeopathic:-
 Homeopathy, founded by a German physician Samuel Hahnemann in
1790, is based on the idea that ‘like cures like’; that is substances
that cause certain symptoms in a healthy person can also cure those
same symptom in someone who is sick.
 This so called law of similar gives homeopathy its name ‘homeo’ for
similar ‘pathy’ designating disease.

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 Unani system of medicines originated in Greece and is based on the
teachings of Hippocrates and Gallen and it developed in to an elaborate
medical system by Arabs, like Rhazes.
 The basic theory of Unani system is based upon the well- known four -
humour theory of Hippocrates. This presupposes the presence, in the body,
of four humours viz., blood, phlegm, yellow bile and black bile.
Unani:-

7. In recent years, there has been great demand for plant derived
products in developed countries. These products are increasingly
being sought out as medicinal products, nutraceuticals and
cosmetics.
Standardization of herbal medicines is the process of prescribing
a set of standards or inherent characteristics, constant parameters,
definitive qualitative and quantitative values that carry an
assurance of quality, efficacy, safety and reproducibility.
Standardization” expression is used to describe all measures,
which are taken during the manufacturing process and quality
control leading to a reproducible quality.
STANDARDIZATION:-
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8. NEED OF STANDARDIZATION:-
When traditional medicines were developed technology and
concept of standardization was quite different.
During past thousand years dynamic process of evolution may
have changed the identity of plant material.
Due to commercialization, supply of genuine raw material has
become a challenge.
Properties of botanicals may have undergone change due to time
and environmental factors
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9. QUALITY CONTROL METHODS FOR HERBAL DRUGS
 Powder fineness and sieve size
 Determination of foreign matter
 Macroscopic and microscopic
examination
 Thin-layer chromatography
 Determination of ash
 Determination of extractable
matter
 Determination of water and
volatile matter
 Determination of volatile oils
 Determination of bitterness value
 Determination of haemolytic
activity
 Determination of tannins
 Determination of swelling index
 Determination of foaming index
 Determination of pesticide residues
 Determination of arsenic and heavy
metals
 Determination of microorganisms
 Radioactive contamination
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10. POWDER FINENESS AND SIEVE SIZE:-
Powders:-
 The coarseness or fineness of a powder is classed according to the nominal
aperture size expressed in hum of the mesh of the sieve through which the
powder will pass.
Descriptive term Particle size
Coarse (2000/355) All the particles will pass through a No. 2000
sieve, and not more than 40% through a No. 355
sieve
Moderately coarse (710/250) All the particles will pass through a No. 710 sieve,
and not more than 40% through a No. 250 sieve
Moderately fine (355/180) All the particles will pass through a No. 355 sieve,
and not more than 40% through a No. 180 sieve
Fine (180) All the particles will pass through a No. 180 sieve
Very fine (125) All the particles will pass through a No. 125 sieve
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11. DETERMINATION OF FOREIGN MATTER:-
Medicinal plant materials should be entirely free from visible signs of
contamination by moulds or insects, and other animal contamination,
including animal excreta. No abnormal odour, discoloration, slime or signs
of deterioration should be detected.
Procedure:-
100-500g of sample
Spread out as a thin layer
Detected by inspection eye/lens
Separate & weigh
Calculate the percentage
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12. MACROSCOPIC AND MICROSCOPIC EXAMINATION:-
Macroscopic examination:-
Size:-measured by graduated ruler.
Colour:-sample Vs reference – colour comparison.
Surface characteristics, texture & fracture characteristics:-
Examined by using a magnifying lens.
Odour:-characteristic & strength of the odour (weak, none, distinct, strong)
and odour sensation (aromatic, fruity, rancid, mouldy etc.)
Taste:-applied only if required specifically.
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13. Microscopic examination:-
 Preliminary treatment.
 Preparation of specimens
 Classification of microscopic particles
 Histo chemical detection of cell walls & contents
 Disintegration of tissues
 Measurement of specimens-microscope, stage micrometer,
ocular micrometer
 Leaf surface data
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14. THIN-LAYER CHROMATOGRAPHY:-
 Thin-layer chromatography is particularly valuable for the qualitative
determination of small amounts of impurities.
type of adsorbent and method of activation; if no information on the
latter can be obtained, heat at 110°C for 30 minutes;
 Method of preparation and concentration of the test and reference
solutions;
 Volume of the solutions to be applied on the plate;
 Mobile phase and the distance of migration;
 Drying conditions (including temperature) and method of detection;
 For the spots obtained:
− Number and approximate position, or the Rf values
− Fluorescence and colour.
Rf Value = -------------------------------------
Distance travelled by solute
Distance travelled by solvent
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15. DETERMINATION OF ASH:-
 The residue remaining after incineration is the ash constant of the drug,
which simply represents inorganic salts, naturally occurring in drug or
adulterating, identification
Method:-
Determinationof Total ash:-
2-4gof powder
500-600o
c until white
Ignited on platinum or silica crucible
Cool in desiccators for 30min
Weigh & calculate the content of total ash
in mgper gof air-dried material.
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16. Determination of acid insoluble ash:-
Ash obtained in total ash
Add to the beaker & add 25mL of 2M hydrochloric acid
Collect the insoluble matter by filtration using ash less filter paper
Ignite the filter paper
Cool the obtained ash in dessicator for 30 min
Weigh & calculate the content of acid insoluble ash in mg per g of air-dried material.
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Determination of water-soluble ash
Ash obtained from total ash
Add to the beaker & add 25mL of water
Collect the insoluble matter by filtration using ash less filter paper
Ignite the filter paper
Cool the obtained ash in dessicator for 30 min
Weigh & calculate the content of water soluble ash in mg per g of air-dried material.

18. DETERMINATION OF EXTRACTABLE MATTER:-
 This method determines the amount of active constituents extracted with
solvents from a given amount of medicinal plant material.
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Hot-extraction method:-
4.0g of coarsely powdered air-dried material, accurately weighed, in a glass-stoppered conical flask.
Add 100ml of water and weigh to obtain the total weight including the flask.
Shake well and allow to stand for 1 hour.
Reflux condenser to the flask and boil gently for 1 hour; cool and weigh.
Shake well and filter rapidly through a dry filter.
Transfer 25 ml of the filtrate to a tarred flat-bottomed dish
Dry at 105°C for 6 hours, cool in a desiccator for 30 minutes,
Weigh & calculate the content of extract in mg per g of air-dried material.

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Cold-extraction:-
4.0g of coarsely powdered air-dried material, accurately weighed, in a glass-stoppered conical flask.
Macerate with 100ml of the solvent specified for the plant material concerned for 6 hours,
Shaking frequently, then allow to stand for 18 hours.
Transfer 25 ml of the filtrate to a tared flat-bottomed dish
Dry at 105°C for 6 hours, cool in a desiccator for 30 minutes
Weigh & calculate the content of extract in mg per g of air-dried material.

20. DETERMINATION OF WATER AND VOLATILE MATTER:-
 An excess of water in medicinal plant materials will encourage
microbial growth, the presence of fungi or insects, and deterioration
following hydrolysis.
 The Azeotropic method gives a direct measurement of the water present
in the material being examined.
 When the sample is distilled together with an immiscible solvent, such
as toluene R or xylene R, the water present in the sample is absorbed by
the solvent. The water and the solvent are distilled together and
separated in the receiving tube on cooling.
 If the solvent is anhydrous, water may remain absorbed in it leading to
false results. It is therefore advisable to saturate the solvent with water
before use.
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21.  The test for loss on drying determines both water and volatile
matter.
 Drying can be carried out either by heating to 100-105 °C or in
a desiccator over phosphorus pentoxide R under atmospheric or
reduced pressure at room temperature for a specified period of
time.
 The desiccation method is especially useful for materials that
melt to a sticky mass at elevated temperatures.
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22. DETERMINATION OF VOLATILE OILS:-
 Volatile oils are characterized by their odour, oil-like appearance and ability
to volatilize at room temperature.
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Method:-
Specified quantity of material
Heating
After 10 min, recorded volume of oil collected
Substract from solvent to use
Difference gives volume of oil in sample
Calculate oil content as mL/100g

23. DETERMINATION OF BITTERNESS VALUE:-
 Medicinal plant materials that have a strong bitter taste ("bitters") are
employed therapeutically, mostly as appetizing agents.
 The bitter properties of plant material are determined by comparing the
threshold bitter concentration of an extract of the materials with that of a
dilute solution of quinine hydrochloride R. The bitterness value is expressed
in unit’s equivalent to the bitterness of a solution containing 1g of quinine
hydrochloride R in 2000 ml.
Where a = the concentration of the stock solution (SaT) (mg/ml),
b = the volume of ST (in ml) in the tube with the threshold bitter con- centration,
c = the quantity of quinine hydrochloride R (in mg) in the tube with the threshold
bitter concentration.
Bitterness
2000xC
axb
=
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Method:-
Taste l0ml of the most dilute solution
Swirling it in the mouth mainly near the base of the tongue for 30 seconds.
If the bitter sensation is no longer felt in the mouth after 30 seconds,
Then rinse with safe drinking-water.
The next highest concentration should not be tasted until at least 10 minutes have passed.
The threshold bitter concentration is the lowest concentration at which a material continues to
provoke a bitter sensation after 30 seconds.

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After the first series of tests, rinse the mouth thoroughlywith safe drinking-water until no bitter
sensation remains.
Wait for at least 10 minutes before carryingout the second test.
Calculate the bitterness value in units per gusingthe following formula
All solutions and the safe drinking-water for mouth washingshould be at 20-25 °C.

26. DETERMINATION OF HAEMOLYTIC ACTIVITY:-
 The haemolytic activity of plant materials, or a preparation containing
saponins, is determined by comparison with that of a reference material,
saponins, which has a haemolytic activity of 1000 units per g.
Method:-
Suspension of erythrocytes
Mixed
Equal volumes of a serial dilution of the plant material extract.
Stand for 10 min
Lowest concentration to effect complete haemolysis is determined
Haemolytic activity =
1000xa
b
Where 1000 = the defined haemolytic activity of saponins R in relation to ox blood,
a= quantity of saponins
b= quantity of drug
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27. DETERMINATION OF TANNINS:-
Method:-
Sample + 150ml of water
Cool, transfer the mixture to a 250-ml volumetric flask and dilute to volume with water.
Allow the solid material to settle
Filter the liquid through a filter-paper, diameter 12cm
Discarding the first 50ml of the filtrate.
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28. Total amount of material Amount of plant material not solubility of hide
powder,
that is extractable into water, bound to hide powder
Evaporate 50.0ml of the plant 80ml of the plant material extract, 6g of hide powder
material extract to dryness add 6g of hide powder + 80ml of water
dry,1050
c,4hrs shake shake
Weigh (T1). Filter and evaporate 50.0 ml of, Filter and evaporate 50 ml
the clear filtrate to dryness of the clear filtrate to dry
dry 1050
c dry 1050
c
Weigh (T2) Weigh (T0)
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29. Where w = the weight of the plant material in grams
T0= solubility of hide powder
T1= total amount of material that is extractable into water
T2= amount of plant material not bound to hide powder
Quantity of tanins =
[T1-(T2-T0)]X500
W
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30. DETERMINATION OF SWELLING INDEX:-
 The swelling index is the volume in ml taken up by the swelling of 1 g of
plant material under specified conditions.
Method:-
1 g of plant material into 25 mL measuring cylinder +25mL water
Shake the mixture thoroughly every 10 minutes for 1 hour
Allow to stand for 3 hours at room temperature, or as specified
Measure the volume in ml occupied by the plant material, including any sticky mucilage.
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31. DETERMINATION OF FOAMING INDEX:-
 Many medicinal plant materials contain saponins that can cause a
persistent foam when an aqueous decoction is shaken.
1 g of the plant material + 100ml of water (500mL conical flask)
Cool and filter into a 100-ml volumetric flask
Pour the decoction into 10 stoppered test-tubes in successive portions
Dilute to volume (10ml) with water.
Allow to stand for 15 minutes
Measure the height of the foam.
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32. DETERMINATION OF PESTICIDE RESIDUES:-
 Medicinal plant materials are liable to contain pesticide residues which
accumulate from agricultural practices, such as spraying, treatment of
soils during cultivation, and administration of fumigants during storage.
Maximum residue limit can be calculated by using following formula:-
Where ADL= Acceptable daily limit
W= body weight
MDI=Mean daily intake of drug
E=Extraction factor
Maximum residue limit =
MDI X (100 X Safety factor)
ADL X W X E
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33.  Contamination of medicinal plant materials with arsenic and heavy metals
can be attributed to many causes including environmental pollution and
traces of pesticides.
Limit test for arsenic:-
 The amount of arsenic in the medicinal plant material is estimated by
matching the depth of colour with that of a standard stain.
Limit test for cadmium and lead:-
 The method of determination is left to the analyst. Nevertheless, the
determination must be consistent and sensitive enough to allow comparison
with a reference material.
DETERMINATION OF ARSENIC AND HEAVY METALS
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34. RADIOACTIVE CONTAMINATION:-
 A certain amount of exposure to ionizing radiation cannot be avoided since
there are many sources, including radionuclides occurring naturally in the
ground and the atmosphere.
Method of measurement:-
Since radionuclides from accidental discharges vary with the type of facility
involved, a generalized method of measurement is so far not available.
However, should such contamination be of concern, suspect samples can be
analysed by a competent laboratory. Details of laboratory techniques are
available from the International Atomic Energy Agency (IAEA).
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35. DETERMINATION OF MICROORGANISMS:-
 Medicinal plant materials normally carry a great number of bacteria and
moulds, often originating in soil. While a large range of bacteria and fungi
form the naturally occurring microflora of herbs, aerobic spore-forming
bacteria frequently predominate.
 Current practices of harvesting, handling and production may cause
additional contamination and microbial growth.
 The determination of Escherichia coli and moulds may indicate the
quality of production and harvesting practices.
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36. Method:-
Preparation of sample solution (plant extract)
Preparation of culture media
Sample added to the culture media
Incubate for 24hrs to 48hrs at aseptic condition
Growth of microorganisms can be identified by turbidity/staining with suitable reagents
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37. CONCLUSION:-
 The traditional medicines cater about 85% of the world population for
their health needs.
 It is essential to maintain safety, quality and efficacy of the plant and their
products to avoid and serious health problems.
 Due to commercialization, supply of genuine raw material has become a
challenge.
 Properties of botanicals may have undergone change due to time and
environmental factors.
37

38. REFERENCES:-
38
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