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1. QUALITY CONTROL OF
DRUGS OF NATURAL ORIGIN
DR. SIDDHI UPADHYAY
H.O.D. & ASSOCIATE PROFESSOR
Dept. of pharmacognosy and phytochemistry
SIGMA INSTITUTE OF PHARMACY

2. CONTENT
1.Adulteration of drugs of natural origin
2.Drug Evaluation
1.Organoleptic Evaluation
2.Microscopic Evaluation
1.Qualitative Microscopic Evaluation
2.Quantitative Microscopic Evaluation
3.Chemical Evaluation
4.Physical Evaluation
5.Biological Evaluation

3. ADULTERATION OF
DRUGS OF NATURAL
ORIGIN

4. ADULTERATION AND EVALUATION
• Adulteration is a practice of substituting original
crude drug partially or wholly with other spurious
substances, but later is either free from or inferior in
chemical and therapeutic properties.
• Adulteration means
• Deterioration
• Admixture
• Sophistication
• Substitution
• Inferiority
• Spoilage

8. DRUG EVALUATION

11. • The ovoid tears of gum acacia, ribbon shaped characteristic of
tragacanth, disc-shaped structure of nux vomica, conical shape
of aconite, quills of cinnamon etc. are important diagnostic
characters.
• The general appearance of the lot of a crude drug often indicates
whether it is likely to comply with prescribed standards, such as
percentage of seed in colocynth, stalk in clove, etc.
• Over drying, makes leaf drugs and flowers brittle and cause
them to break in transit making the task of morphological
evaluation difficult.
• The wavy shape of Rauwolfia, pungent taste of capsicum and
ginger, brown colour of cinnamon, odour and taste of spice-
drugs like, asafoetida, black pepper, nutmeg, caraway, cummin,
etc. are important diagnostic organoleptic characteristics.

13. • Microscopic evaluation also covers study of the constituents by
application of chemical methods to small quantities of drugs in powdered
form or to histological sections of the drug (Microchemistry or
chemomicroscopy).
Examples:
• A drop of phoroglucinol and concentrated hydrochloric acid give red
stain with lignin.
• Mucilage is stained pink with ruthenium red and also, when treated with
corallin soda and few drops of sodium carbonate solution, cellulose
swells and dissolves in cuoxam,
• while N/50 iodine solution stains blue starch and hemicelluloses.
• Histological studies are made from very thin sections of drugs.
• The characteristics of cell walls, cell contents, starch grains, calcium
oxalate crystals, trichomes, fibres, vessels, etc. can be studied in detail
• e.g. lignified trichomes in nux vomica, warty trichomes of senna, wavy
medullary rays of cascara bark, glandular trichomes of mint etc. Some
important types of Trichomes are shown below.

14. • Microscopic linear measurements and quantitative microscopy are also covered
under this technique of evaluation.
• The powdered cloves do not contain sclereid or calcium oxalate crystals, but both
of them are present in powdered clove stalks.
• Powdered clove fruits show presence of starch while it is absent in cloves.
• Presence of non-lignified vessels in powders of rhubarb and ginger indicate
adulteration
• Other important histological aspect is the quantitative microscopy and linear
measurements. The various parameters studied here are stomata number and
index, palisade ratio, vein-islet number, size of starch grains, length of fibres, ete.
• Senna varieties are distinguished by differing stomata number and palisade ratio.
The diameter of starch grains in Cinnamomum cassia is 10 microns; hence, useful
for detecting adulterants. The number of sclerenchymatous cells per square mm
of cardamom is useful for detecting different varieties of cardamom seed.

17. ATROPA
BELLADONA
Leaf Constants
Stomatal Number 77-115 (Lower Epidermis)
Stomatal Index 20.2-23 (Lower Epidermis)
Vein Termination Number 6.3-10.3
Palisade ratio 6-10

18. DIGITALIS
PURPUREA
Leaf Constants
Vein Islet Number 2-5.5
Palisade ratio 3.7-4.2

30. There are six forms of calcium oxalate crystals in plants as follows:
(I) Cubical (Prisms): As the name indicates, these crystals are cubical' in
shape (i.e. th . width and length is equal) and also have three equal axes,
all at right angles to one
(2)Rhombic (Diamond Shaped): Here crystals have three axes, which axes
are at right to each other and unequal in length.
(3)Tetragonal: This is characterized by presence of three axes, at right
angles to one vertical or principal axis.
(4)Monoclinic: This form has three axes and all the three are unequal. The
lateral two at right angles to each other, while the third. i.e. Principal is at
right angles to lateral The monoclinic crystals shine more than the
tetragonal system.

31. (5)Acicular: These are excessively long slender forms,
with pointed ends and normally
(6)Rosettes (Clusters): These are also aggregate crystals.
This type has shape similar to full expanded rose flower
and hence the name rosettes
Apart from above six types many times, very minute
deltoid or arrow-shaped crystals occupying the full cells
in which they occur, are also reported. They are known
as Microsphenoidal or sandy crystals of calcium oxalate.

33. M = weight in mg of the sample, calculated
on basis of sample dried at 1050 C P =
2,86,000 in case of ginger starch grains
powder
Lycopodium spore method can be used for
evaluation of powdered clove, ginger,
cardamom,nutmeg,umbelliferous fruits, etc.

37. Water immiscible solvent, such as light petroleum is used for the
extraction of fixed and essential oils, steroids and aglycones.
Chloroform and ether are used for the separation of alkaloids and
quinines.
The extraction of organic bases like alkaloids usually necessitates
basification of plant material if a water immiscible solvent is to be
used while for aromatic acids and phenols, acidification may be
required.
The glycosides are soluble in water and alcohol, but
insoluble in non-polar solvents.
Tannins are phenolic matter soluble in water, alcohol and ethyl
acetate. Extraction itself may be performed by repeated maceration
with agitation, percolation or by continuous extraction using
Soxhlet extractor.

39. • Each extract is concentrated by distilling off the
solvent and then evaporating to dryness on
water-bath.
• The extract obtained with each solvent is weighed.
Its percentage is calculated in terms of air-dried
weight of plant material. The colour and consistency
of the extract are noted.
• The extracts with different solvents can also be
prepared by successively macerating (co extraction)
the powdered drug in order of increasing polarity.
• The general approach for extraction of different
constituents from fresh plant may be briefly
described in the following chart

46. 4. PHYSICAL EVALUATION
• MOISTURE CONTENT
• OPTICAL ROTATION
• REFRACTIVE INDEX
• MELTING POINT
• VISCOSITY
• SOLUBILITY
• ASH VALUES
• EXTRACTIVE VALUES
• VOLATILE OIL CONTENT

47. • MOISTURE CONTENT:
• The percentage of active chemical constituents in crude
drugs is mentioned on air dried basis
• Moisture content of the crude drug is minimized in order to
prevent
decomposition of crude drugs due to microbial contamination
• M.C Is determined by heating a drug at 1050C in an oven to a
constant weight
• Ex:
• Starch - 15% w/w
• Digitalis - 5% w/w
• Ergot - 8% w/w

48. • VISCOSITY:
• Viscosity of a liquid is constant at a given temperature and is an
index of its composition. Hence it can be used as a means of
standardising liquid drugs
• Ex:
• Pyroxylin – 1100 – 2450 Centistokes at 370c
• Liquid Paraffin - 64 centistokes at 37.80c

49. • MELTING POINT:
• In case of pure chemicals the melting point is sharp and constant
• Since the crude drugs contain mixed chemicals they are
described with certain range of melting point
• Kokum butter - 75-850c
• Bees wax - 62- 65 0c
• Wool fat 34 - 44 0c

50. • SOLUBILITY:
• Castor oil is soluble only in 3 volumes of 90%
alcohol
• Balsom of peru is soluble in chloral hydrate
solution
• Colophony is soluble in light petroleum
• Asafoetida soluble in Carbon disulphide
• Alkaloidal bases are soluble in chloroform
• Alkaloidal salts are soluble in polar solvents

51. • OPTICAL ROTATION:
• Some substances have the property of rotating the plane of
polarised light in the pure state or in the solution
• They are called as optically active
• This property is called as optical rotation
• Plane of polarised light may be rotated towards right or left
• Normally it is determined at 250c using sodium lamp as the source of
light
• Ex:
• Castor oil - +75 to +80
• Honey - +3 to -15
• Eucalyptus oil - 0 to +10

52. • REFRACTIVE INDEX:
• When a ray of light is passed to one medium to another
medium of different density it bent from original path
• The ratio of velocity of light in vaccume to its velocity in the
substance is
termed as refractive index
• It varies with wavelength , temperature, and pressure
• Sodium light was used at 250c
• Ex:
• Arachis oil - 1.4678 to 1.470
• Castor oil - 1.4758 to 1.527
• Clove oil - 1.527 to 1.535

53. • Ash Values:
• The residue remaining after incineration is the ash value
• It consists of in organic salts, in the form of naturally occuring or
adhering to it or deliberately added to it, as a form of adulteration
• Physiological ash: it is derived from the plant tissues
• Non physiological ash: It consists of extraneous matter like sand,
soil etc
• Total ash contains carbonates, oxides, phosphates, silicates and
silica

54. • Ex
:
DRUG TOTAL ASH (% w/w) ACID INSOLUBLE
ASH(%
w/w)
Cardamom 6.0 3.5
Cannabis 15.0 5.0
Clove 7.0 0.75

55. • EXTRACTIVE VALUES:
• The extracts obtained by crude drugs are called extractive values
• Various solvents are used to determine the extractive values
• WATER SOLUBLE EXTRACTS:
• The drugs which contains water soluble active constituents of crude
drugs such as tannins, sugars, plant acids, mucilage, glycosides
etc
• Ex:
• Aloe- NLT 25%
• Glycyrrhiza - NLT 20%
• Senna Leaves - NLT 30%

56. • Alcohol soluble extractives
• Alcohol is the common solvent for the extraction of various
chemicals like tannins, resins etc
• 95% ethyl alcohol is used for the alcohol-soluble extractive
• Ex:
• Aloe - NLT 10%
• Benzoin - NLT 90%
• Asafoetida - NLT 50%

57. • VOLATILE OIL CONTENT:
• Pharmaceutical significance of aromatic drugs is due to their
odourous principles .
• Such crude drugs are standardised on the basis of their volatile oil
content
DRUGS VOLATILE OIL CONTENT
(%W/W)
CARAWAY 2.5
CLOVE 15
CARDAMOM SEED 4

58. 5. BIOLOGICAL EVALUATION
Biological evaluation is done to determine
effect & potency of drug in living organisms,
animal preparations or isolated living tissue.
It is also known as bioassay. It can evaluate
both pharmacological activity and
toxicological activity of a drug.
Biological evaluation is done to confirm the
test after physical and chemical test.
Biological evaluation can be:
i) Pre-clinical testing: Testing in laboratory
animals like mouse, rat, pig, dog, etc.
ii) Clinical testing: Testing in human volunteers.

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