Adulteration & Evaluation of Crude Drug

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Adulteration & evaluation of crude drug

Drug Adulteration
Definition:
Adulteration is the debasement of an article(substances). An adulterant
resembles the genuine drugs in respect to its morphological appearance.
OR
Adulteration is substituting the original drug partially or completely
with inferior drug.

Methods of Adulteration :
1) Replacement by exhausted drugs:
It is common with costly drugs. e.g. clove, saffron, ginger
Ex. a) Exhausted saffron is coloured artificially
b) Exhausted Ginger is mixed with starch & coloured to
produce proper shape.
2.Substitution with inferior drugs:
Harvesting of crude drug is done when it has not reach the minimum
standard of quality.
Ex.a). Adulteration of cloves by mother cloves.
b). Saffron is Adulterated with dried flower of safflower.
3.Substitution by artificially manufactured substituent:
It is also observed in case of costly drugs.
Ex.a) Paraffin wax is tinged yellow & substituted for yellow bees wax.
b) Artificial invert sugar is mixed with honey.
4.Substitution by sub- standard commercial varieties:
Commercially produced sub-standard verities are used for adulteration.
Ex. a) Alexandrian senna with Arabian senna.
b) Strychnous nux-vomica adulterated with Strychnous nux-blanda
5. Presence of organic matter obtained from the same plant:
In this case the advantages of similar colour, odour & constituents is
taken into consideration and other parts of the same plant are added
to original drug.
Ex. a) clove are mixed with clove stalks.
b) Caraway fruits are mixed with other parts of inflorescence
6. Adulteration with Synthetic drug and chemicals:
Ex. a) Benzyl benzoate to balsam of peru.
b) Citral to oil of lemon grass.
7. Adulteration with Waste products from the market
Ex .a) Limestone in asafoetida.
b) White oil in oil of Coconut.
c) paraffin in cocoa butter.
Evaluation of crude drug
Definition:
It means confirmation of its identification & determination of its
quality, purity & activity of drug.
The crude drugs can be identify on the basis of their morphology,
microscopy & chemical studies.
Methods of evaluation:
1) Organoleptic Evaluation
2) Microscopic Evaluation
3) Physical Evaluation
4) Chemical Evaluation
5) Biological Evaluation
1) Organoleptic / morphological Evaluation

It refers to evaluation by colour, odour, taste, shape & special features
like touch, texture etc.
E.g. i) Aromatic odour of umbeliferous fruits (e.g. Coriander, fennel)
ii) Sweet taste of liquarice.
The study of forms of crude drugs (color, odour, taste) is known as
morphology.
Morphological characters of crude drugs mentioned in official books can
be considered only as a guidelines & they may vary depending upon
various factors.
E.g. colour of drugs may be fade due to drying in sunlight.
Factors like irrigation, fertilizers, rainfall, temperature may influences
the size of drugs.
Under favourable condition drug get maximum size while in adverse
condition size may get reduced.
e.g. the adulteration of Nux- vomica with Nux blanda.
The adulteration of alexander Senna with dog Senna/ palthe Senna.
e.g. unorganized drug: Gum acacia & tragacanth
Gum acacia is found in the form of ovoid & tragacanth is found in
ribbon shape.
2) Microscopic evaluation:
This method consist of detail examination of a drug.
It is used to identify organized drug by the microscopical character.
In this method microscope is used to give a magnified image of
minute structure.
This magnified image can be used in study structural details of the
drug.
Reagent & stains are used to study various cellular structure.
The characteristic of cell wall, cell contains trichomes, fibers etc. can
be studied in detail.
E.g. Lignified trichomes in Nux-vomica.
leaf constants used for drug evaluation:
a) Stomatal number: it is the average number of stomata per sq.mm.
it is relatively constant for particular species of plant age, & hence it is
consider as a diagnostic character or identification of leaf drugs.
e.g. i) Datura stramonium- 87 (upper epidermis)
ii) Datura inoxia- 141 (upper epidermis)

ii) Stomatal index: It is the percentage of number of stomat’s to the total


number of epidermis cells.
I = S x 100
E+S
where I = Stomatal index
S = Stomatal number
E = number of epidermal cells
e.g. 1) Indian Senna- 17 to 20
2) Alexander Senna- 10.8 to 12.6
iii) Vein islet number: it is the number of islets per sq.mm of
epidermis.
i) It does not alter with age of the plant & size of the drug.
ii) It is used as a diagnostic character for the identification of
crude drugs.
e.g. i) digitalis purpurea – 2 to 5.5
ii) digitalis thapsi – 8.5 to 16
iv) Palisade ratio: it is the average of palisade cell beneath the
one epidermal cell.
e.g. i) Datura stramonium- 4 to 7
ii) Atropa belladonna - 6 to 10
Quantitative Microscopical Evaluation (lycopodium spore
method)
It is an important analytical technique for powdered drugs.
Lycopodium spores are very characteristics in shape and
appearance and exceptionally uniform in size (25μm). On an
average 94,000 spores per mg of powdered lycopodium are present.
This method can be used for evaluation of powdered clove, ginger,
cardamom, etc.

A powdered drug is evaluated by this technique:


i) Well defined particles which may be counted e.g. starch grains
or pollen grains.
ii) Single layered cells or tissues the area of which may be traced
under suitable magnification & actual area calculated for.
The object of uniform thickness the length of which can be measured
under suitable magnification & actual area calculated.
The percentage purity of an authentic powdered ginger is calculated
using following equation:
Percentage Purity = N x W x 94000x100
SxMxP
Where,
N = number of characteristics structures (e.g. starch grains )
in 25 fields
W= weight in mg of lycopodium taken
S= Number of lycopodium spores in the same 25 fields
M= weight in mg of sample
P= 2,86,000 in case of ginger starch grains powder.
Physical evaluation
They may be help in evaluation specifically with reference to specific gravity,
density, optical rotation, refractive index, melting point, viscosity & solubility in
different solvent.
A) Moisture content:
The percentage of active chemical constituents in crude drugs is mentioned on air
dried basis. Hence the moisture content of a drug should be determined and should
be controlled.
The moisture content of a drug should be minimized in order to prevent
decomposition of crude drugs either due to chemical change or microbial
contamination.
The moisture content is determined by heating a drug at 105 0C in an oven to a
constant weight.
For the drug containing volatile active constituents the toluene distillation method
is followed.
Drugs Moisture Content (% w/w)
(Not More Than)
Aloes 10
Digitalis 05
Optical rotation:
 The substance which has the ability to rotate the plane of
polarised light in pure state or in a solution, is an optically
active. The phenomenon is known as optical rotation.
Significance: plane polarized light is rotate towards right
(dextrorotatory) or left side (laevorotatory).
Normally the optical rotation is determined at 250C using
sodium lamp as source of light.
Example of optical rotation:
drug Angle of optical rotation
caraway oil + 70 to +80
clove oil 0 to – 1.5
Viscosity:
Viscosity of a liquid is constant at a given temp. & is an index of
its composition.
Hence it can be used as a means of standardizing liquid drugs.
e.g. liquid paraffin: viscosity not less than 64 centi strokes

Melting point:
these parameters is used for purity of crude drugs. In case of pure
chemical or phytochemical, melting points are very sharp &
constant.
e.g. drug melting point (0C)
bees wax 62- 65
Hard paraffin 50- 57
Refractive index:

 When a ray of light passes from one medium to another of


different density, it is bent from original path. Thus the ratio of the
velocity in vacuum to its velocity in the substance is termed as
refractive index of second medium.
Refractive index of compound varies with the wavelength of the
incident light, temp. & pressure.
Refractive index of a wavelength of the following compound are
for sodium light & at a temp. of 250C.
Drug Refractive Index
caraway oil 1.4678 to 1.4698
Arachis oil 1.4838 to 1.4858
As a mentioned earlier evaluation of drugs basically needs its
identification & can be done by morphological or
microscopical character.
Many times the drug identification by diagnostic character.
i) Ash content
ii) Extractives
iii) Volatile oil.

1. Ash value
What is Ash value? Write its types and give the importance of
ash value in evaluation of drug.
Definition: The residue remaining after incineration is the ash
content of the drug which is called as ash value.
Types of Ash
1) Total ash: Total ash is the inorganic ash obtained on incineration of
the drug and it consist of carbonates, silicates, phosphate and silica.
2) Acid insoluble ash: This is a part of total ash insoluble in dilute
HCL.
3) Water soluble ash: it is used to detect presence of material exhausted
by water in the genuine drug.
4) Sulphated ash value: it is calculated by incinerating the powdered
drug at a temp of about 6000C with dil. H2SO4 before ignition due to
this process all the oxides and carbonate are converted to sulphated salt.
Importance of ash value:
Ash content simply represents the inorganic salts naturally occurring in
drug or adhering to drug or deliberately added to it as a form of
adulteration. Therefore it is a criterion to judge the identity or purity of
crude drugs. It indicates to some extent the care taken in the collection
and preparation of the drug .
2.Extractives
A) Water soluble extractives:
it is applicable to drugs which contains water soluble chemical
constituents like tannins, sugars, glycosides, mucilage, plant acids
etc. e.g. Aloe – NMT 25% w/w
B) Alcohol soluble extractives: (95% ethyl alcohol)
It is an ideal solvent used for extraction of various chemicals like tannins,
resins. e.g. Aloe – NMT 10 % w/w
c) Alcohol insoluble extractives:
Alcohol insoluble extractive values are applicable to same resinous drugs.
e.g. Myrrh – NMT 70 % w/w
d) Ether soluble extractives: two types are there
1) Volatile soluble extractives: volatile oil
2) Non volatile extractives: represents resins, fixed oils, coloring matter
3. Volatile oil contents:
Efficacy of several crude drugs is due to their odorous principals i.e.
volatile oil.
Such crude drugs are standardized on the basis of their volatile oil
contents. E.g. caraway- NMT 2.5 % w/w
4. Chemical evaluation:
It consists of various chemical tests & chemical assays.
It also includes isolation, purification and identification of active
constituents of crude drugs.
i) Chemical tests:
a) Quantitative chemical tests: these are useful in resins, volatile oil,
balsams, gums etc.
b) Qualitative chemical tests: it includes preliminary phytochemical
screening of a crude drug study of chemical constituents of a crude drugs.
e.g. Alkaloids containing: Datura, Belladona, opium.
Chemical reagents also used in identification of crude drugs.
e.g. i) solution of lead acetate or lead sub-acetate used for identification
of gum.
ii) Alkaloids Borntragers test for anthraquinone
iii) Van urk’s reagent for ergot
iv) Vitalis test for tropane
It consists of estimation of chief constituents or group of active
constituents.
e.g. i) total sennosides present in senna.
ii) morphine in opium
iii) Eugenol in clove
iv) citral in lemon grass oil.
Chemical assay:
The conventional titrimetric estimation are used to estimate the
alkaloid contains of crude drugs.
An esters & aldehydes contains volatile oil.
5) Biological Evaluation:
1) Bio-assay:
It is the method in which drug is determined by potency of crude
drug is done by means of its effect on living organisms like bacterial
growth, fungal growth, animal tissue or entire animal.
Bio- assay is the measure of sample being tested, capable of
producing the biological effects as that of standard preparation.
Such activity is represented in International Unit (IU).
E.g. Digitalis- 1 I.U is contains 76 mg of standard preparation
Bio- assay methods are of three types:
i) Toxic
ii) Symptomatic
iii) Tissue method
In toxic & symptomatic methods of bioassay the effect of drug
is observed on entire animal.
In tissue method the effect of drug is observed on isolation
organ or tissue. Drugs subjected to bioassay are:
Cardiac glycosides, vitamins, harmones, antibiotics.
Pharmacopeial standards

Significance of pharmacopoeial standards: by the use of various


pharmacopoeial standards the purity and quality of crude drugs can
determined. Pharmacopeial standards are useful for authentication of
unknown species of crude drug.
Substitution: It involves total replacement of original drug with
totally different substance, contains same type of active chemical
constituents but at a lesser extent.

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