CRUDE DRUGS

A general view of their origin, distributions,

cultivation, collection, drying and storage,
commerce and quality control, classification
of drugs, preparation of drugs for commercial
market, evaluation of crude drugs, drug
adulteration
Definition of crude drug
•Crude drugs are plants or animals, or their parts which after
collection are subjected only to drying or making them into
transverse or longitudinal slices or peeling them in some cases.
Most of the crude drugs used in medicine are obtained from
plants, and only a small number comes from animal and
mineral kingdoms.

•Crude drugs can be regarded as the substances either used

directly or indirectly as a drug which have not been changed or
modified in its chemical composition.

•The crude drugs of natural origin can be divided into two main
categories as organized crude drugs and unorganized crude
drugs.
Importance of crude drugs

• Plant-derived medicines are useful therapeutic options and

often provide a safe form of therapy.
• Crude drugs and their constituents are commonly used as
therapeutic agents. Source of crude drugs are plant (senna,
opium, digitalis and Clove), Animal (Musk, Honey, Shark liver
Oil) and Mineral (Shilajit, Talc, Bentonite).
• Provide lead compounds for the development of new drugs.
Types of crude drugs

• Organized drugs consist of the cellular organization in the form of

anatomical features. These are mostly the crude drugs from plant
sources
• Drugs are the direct parts of the plant and are divided into leaves,
barks wood, root, rhizome, seed, fruit, flower, stem, hair and fibers.
• Microscopical and anatomical studies are preeminent for such
crude drugs. These can be used directly in medicine or can be used
by modifying or by extracting the active ingredient from it. The
simple medicines prepared from these drugs are herbal teas,
extracts, tinctures, etc., and it may be extensively processed for the
isolation and purification of pure therapeutically active constituent
which is ultimately responsible for the action of the drug.
Examples of organized drugs
• Leaves– Digitalis, Eucalyptus, Mint, Senna, Spearmint, Squill,
Tulsi, Coca, Buchu, Hyoscyamus, Belladonna, Tea, etc.
• Barks–Cascara, Cassia, Cinchona, Cinnamon, etc.
• Flowering parts– Clove, Pyrethrum, Chamomile.
• Fruits– Capsicum, Caraway, Cardamom, Coriander, Dill, Fennel,
Lemon peel, Star anise, etc.
• Seeds– Bitter almond, Black Mustard, Cardamom, Colchicum,
Ispaghula,, Linseed, Nutmeg, Nux vomica, etc.
• Roots and Rhizomes– Colchicum, Garlic, Ginger, Ginseng,
Glycyrrhiza, etc.
Types of Crude Drug

Unorganized drugs:
• These are drugs which have no cellular or tissue structure and are
obtained from plants as their exudates. e.g. gums, resins, aloe,
honey, essential oils, etc.
• Microscopical studies are not required for such crude drugs.
These includes products like plant exudates as gums, oleogums,
oleogum resins, plant lattices like that of opium, aloetic juices
like aloes or dried extracts of black and pale catechu, agar, alginic
acid, etc.
• Other products like essential oils, fixed oils, fats and waxes
obtained from vegetable or animal sources, although hydro-
distilled or extracted from plant, become the direct commodity for
use
Differences between organized and unorganized drugs
Organized Drugs Unorganized Drugs

These may be of plant or These may be of plant, animal

animal origin. or mineral origin.

These are direct part of plants These are the product of plant
or animals. or animals.

These have well defined These do not have well defined

cellular structure. cellular structure.

Generally identified by Generally identified by

morphological character. organoleptic properties.
 Sources of crude drugs

• The most important natural sources of crude

drugs are;
1- Plants
2- Animals
3- Microbes
4- Marine organisms
5- Minerals
1- Plants
o Crude drugs are obtained from various plant parts e.g.

o These drugs have active constituents, responsible for their medicinal

effects. After understanding the chemical structure of active constituents,
their semi-synthetic derivatives have been prepared in laboratory. e.g.
Homatropine is a semi-synthetic derivative of Atropine
2- Animals

oA number of crude drugs are obtained from animals. e.g.

Oils ------------Cod liver oil
Fats------------Wool fat
Hormones----Insulin, Sex Hormones
oAfter knowing the structures of active constituents, their
semi-synthetic derivatives have been produced.
3- Microbes
oAnti-biotic drugs have been prepared from
bacteria and moulds for treating the infections.
e.g. Penicillin from Penicillium notatum.
oSome vitamins are also obtained from bacteria.
oStreptokinase-an enzyme used to dissolve the
blood clot in vessels is also obtained from
bacteria.
oInsulin is obtained from E. coli by Recombinant
DNA Technology.
4- Marine Organisms

Compound Name Marine Organism Therapeutic Use

Cytarabine Sponge Anticancer
Vidarabine Sponge Antiviral

Omega-3 Fatty Acid Ethyl Fish Antihypertriglyceridemia

Esters

Ziconotide Cone Snail Analgesic

5- Mineral Sources

o Metals, metalloids and non-metal substances are used as drugs.

o Mercury was one of the earliest drugs to be used for the treatment of
syphilis.
o Iron is used to treat anaemia
o Iodine is used for thyroid problems and as antiseptic.
Classification of crude drugs

• Alphabetical classification
• Morphological classification
• Pharmacological classification
• Chemical classification
• Taxonomic classification
• Chemo- taxonomical classification
An ideal method of classification of crude drugs should be;
• Simple
• Easy to use
• Free from confusion and ambiguities
 1. Alphabetical classification
Alphabetical classification is the simplest way of
classification
• Crude drugs are arranged in alphabetical order of their:
• Botanical names
• Common names
• Local/ vernacular names
The following pharmacopoeia classify crude drugs
according to this system:
• British Pharmacopoeia
• British Herbal Pharmacopoeia
• United States Pharmacopoeia and National Formulary
• European Pharmacopoeia
1. Alphabetical classification

Advantages of alphabetical system

• It is easy and quick to use
• There is no repetition of entries and is devoid of confusion.
• In this system location, tracing and addition of drug entries is easy
• Disadvantage
• There is no relationship between previous and successive drug
entries
• E.g. Acacia, Benzoin, Cinchona, Dill, Ergot, Fennel, Gentian,
Hyoscyamus, Ipecacuanha, Jalap, Kurchi, Liquorice, Mints,
Nuxvomica, Opium, Podophyllum, Quassia, Rauwolfia, Senna,
Vasaka, Wool fat, Yellow bees wax, Zeodary
2. Morphological classification

•In this system, the drugs are arranged according to the morphological
or external characters of the plant parts or animal parts. i.e. which
part of the plant is used as a drug e. g. leaves, roots, stem
•The drugs obtained from the direct parts of the plants and containing
cellular tissues are called as organized drugs, e.g. rhizomes, barks,
leaves, fruits, entire plants, hairs and fibers.
•The drugs which are prepared from plants by some intermediate
physical processes such as incision, drying or extraction with a solvent
and not containing any cellular plant tissues are called unorganized
drugs. Aloe juice, opium latex, agar, gambir, gelatin, tragacanth,
benzoin, honey, beeswax, lemon grass oil, etc., are examples of
unorganized drugs.
3. Pharmacological classification

• This involves grouping of drug according to their

pharmacological action.
• This is also referred to as therapeutic
classification of drugs.
• Drugs like digitalis, squill and strophanthus
having cardiotonic action are grouped together
irrespective of their parts used or their
phytoconstituents.
 Classification of Drugs based on Pharmacological action
Pharmacological Action Drugs

Anticancer Vinca, Podophyllum, Taxus

Anti-inflammatory Colchicum, Turmeric
Antiamoebic Ipecac root, Kurchi bark
Antiasthmatic Ephedra, Lobelia
Anthelminthic Male fern, Quassia wood
Antispasmodic Datura, Hyoscyamus
Astringent Catechu
Analgesic Opium, poppy
Bitter tonic Quassia wood, Nux-vomica, Gentian
Carminatives Coriander, fennel, clove, peppermint
Purgatives Senna, Rhubarb
Expectorant Tulsi, Balsam of Tolu
Cardiotonic Digitalis, Squill, Strophanthus
Tranquilizers Rauwolfia Roots
Pharmacological Classification

ADVANTAGE

• This system of classification can be used for suggesting substitutes of drugs if

they are not available at a particular place or point of time.

DISADVANTAGE

• Drugs having different action on the body gets classified separately in more
than one group that causes ambiguity and confusion.

• E.g. Cinchona is an antimalarial drug because of presence of quinine but can

be put under the group of drug affecting heart because of antiarrythymic
action of quinidine.
Chemical Classification
• The crude drugs are divided into different groups
according to the chemical nature of their
constituent.
• In chemical classification drugs having identical
constituents are placed in one group.
1. Carbohydrates
• Gums - Acacia, Tragacanth, Guargum
• Mucilage - Plantago seed
• Others include Starch, Honey, Agar, Pectin, Cotton
Chemical Classification

2. Glycosides
• Anthraquinone Glycosides - Aloe, Cascara, Rhubarb, Senna
• Saponins Glycosides - Glycyrrhiza
• Cyanogenetic Glycosides - Cassava
• Isothiocyanate Glycosides - Mustard
• Cardiac Glycosides - Digitalis, Strophantus
• 3. Tannins
• Tannins are astringent, bitter polyphenols that precipitate proteins.
• Tannins causes a dry and puckering feeling in the mouth.E.g.- Guava,
Tea
Chemical Classification

• 4. Volatile oils
• Monoterpenes and sesquiterpenes obtained
from plants.
• Examples- Cinnamon, Fennel, Dill, Caraway,
Coriander, Cardamom, Orange peel, Mint,
Clove
5. Lipids
• Fixed oils – Castor, Olive, Almond, Shark liver
oil
• Fats – Theobroma, Lanolin
• Waxes – Beeswax, Spermaceti
Chemical Classification

6. Alkaloids
• Nitrogenous substances of plant origin
• Pyridine and Piperidine – Lobelia, Tobacco
• Tropane - Coca, Belladonna, Datura, Stramonium, Hyoscyamus
• Quinoline – Cinchona
• Isoquinoline – Opium, Ipecac
• Indole – Ergot, Rauwolfia
• Amines – Ephedra
• Purine bases – Tea, coffee
Chemical Classification

• Advantages :
• Chemical constituents are known,
• Medicinal uses are known
• Disadvantages :
• Drugs of different origin are grouped under similar
chemical
titles.
• This type of classification makes no proper placement of
drugs containing two different types of chemicals.
• Eg: Certain drugs are found to contain alkaloids and
glycosides (Cinchona), Fixed oil and volatile oil (Nutmeg) of
equal importance together and hence it is difficult to
categorize them properly
Taxonomic classification
• Based on an accepted system of botanical
classification
• Grouped into:
• Kingdom
• Phylum
• Order
• Family
• Genus
• Species
Taxonomic classification

Advantages:
• Easy for the classification of crude drugs
Disadvantages:
• The system is criticized for its failure to recognize the
organized / unorganized nature of crude drugs in their
morphological studies.
• The system fails to face into an account chemical nature of
active constituent and therapeutic significance of crude
drugs.
• The drugs obtained from plants having alternate leaves,
flowers, seeds, capsules (Hyocyamus, Datura, Belladonna,
Stramonium) are considered with other members of
Solanaceae.
Chemo- taxonomical classification of crude
drugs
• In this system of classification, the equal importance
is given for taxonomical status and chemical
constituents. There are certain types of chemical
constituents which are characteristics of certain
classes of plants.
• E.g.: Tropane alkaloids generally occur in most of the
members of Solanaceae
• E.g.: Volatile oils occur in the members of Umbelliferae
and Rutaceae.
Advantages
• Allows for precise and ordered arrangement of drugs.
• Accommodates any drug without ambiguity
Medical terminologies
• Arthritis -Inflammation of a joint
• Asphyxia -Inability to breath
• Atrophy -Wasting of a tissue or organ
• Carcinogenic- Causing cancer
• Carcinoma- A malignant epithelial tumour eventually becoming
fatal
• Cardiotonic- An agent that has a stimulating effect on the heart;
increasing the strength and tone of the heart.
• Cardiac depressant- Slowing the action of the heart
• Carminative Drug- causing the release of stomach or intestinal
gas.
• Mydriatic: Drug that causes dilatation of the pupil.
• Miotic: Contraction of pupil of eye
Medical terminologies
• Cathartic -Having the power of cleaning the bowels (laxative,
purgative, drastic)
• Dermatitis - Inflammation of the skin
• Diuretic - Increasing the flow of urine
• Dyspepsia – Difficulty in digestion
• Dysuria - Difficulty or pain while passing urine
• Emetic -Causing vomiting
• Expectorant - Aiding the secretion of the mucous
membrane of the air passages and the removal of fluid
• Haematemesis - Vomiting of blood
• Haematuria - The presence of blood in the urine
• Heamatinic: Therapeutic agent that causes increase in the
heamoglobin content of the blood.
• Insomnia: Difficulty in sleeping or staying asleep.
Cultivation of Crude Drugs

Cultivation of Crude Drugs

Cultivation of medicinal plants requires intensive care and
management. The conditions and duration of cultivation required vary
depending on the quality of medicinal plant materials required.
• Methods of Propagation:
• Vegetative propagation (Asexual propagation):
• Vegetative propagation can be defined as regeneration or formation
of a new individual from any vegetative part of the plant body. The
method of vegetative propagation involves separation of a part of
plant body, which develops into a new plant.
• B. Seed Propagation (Sexual Propagation):
Cultivation of Crude Drugs

• Methods of vegetative propagation:

• They are two types:
• 1. Methods of natural vegetative propagation:
• 2. Methods of artificial vegetative propagation.
• A. Methods of natural vegetative propagation:
• a. Vegetative propagation by stem:
• Runner: peppermint.
• (i) Bulb:
• Allium, Squill.
• (ii) Corms:
• Colchicum.
Cultivation of Crude Drugs

• (iii) Tuber:
• Potato, aconite.
• (iv) Offset:
• Valerian.
• (v) Rhizome:
• Ginger and haldi
• b. Vegetative propagation by root: examples:
• Asparagus
• 2. Methods of artificial vegetative propagation:
• Various parts developed for natural vegetative propagation have also
been used for artificial vegetative propagation.
Cultivation of Crude Drugs
• Following methods are used:
1. Cutting:
• These are the parts of the plant (stem, root or leaf) which, if grown
under suitable’ conditions, develop new plants. Stem cutting are
generally used to obtained new plants. Examples: Sugarcane and
rose, etc.
2. Layering:
• Roots are induced on the stem while it is still attached to the
parent plant. This part of stem is later detached from the parent
plant and grown into a new plant.
3. Grafting:
• New variety is produced by joining parts of two different plants.
The rooted shoot of one plant, called stock, is joined with a piece
of shoot of another plant known as scion. Examples: Rose, citrus
and rubber, etc.
 Cultivation of Crude Drugs
• 4. Micro propagation:
• This method consists of growing cell, tissue and organ in
culture. Small pieces of plant organs or tissues are grown
in a container with suitable nutrient medium, under
sterilized conditions. The tissue grows into a mass of
undifferentiated cells called callus which later differentiates
into plantlets. These are then transferred into pots or
nursery beds and allowed to grow into full plants.
• B. Seed Propagation (Sexual Propagation):
• The process of sexual propagation:
• (i) Microsporogenesis:
• Microspores are formed from microspore mother cells
inside the anther.
• (ii) Pollination:
• This is the transfer of pollen grains from the anther to the
stigma.
Cultivation of Crude Drugs
• iii) Microgametogenesis:
• This involves the formation of male gametes from
microspore.
• (iv) Megasporogenesis:
• This process leads to the formation of megaspores from
megaspore mother cell, inside the ovule.
• (v) Megagametogenesis:
• The events involving the formation of embryo sac from
megaspore are included in this process.
• (vi) Fertilization:
• Fusion of male and female gametes takes place, resulting
in the formation of zygote.
• (vii) Embryogeny:
• The process involves development of embryo from zygote.
Collection of drugs

• Time of collection:
• Medicinal plant materials should be collected during the
appropriate season or time period to ensure the best possible
quality of both source materials and finished products. It is well
known that the quantitative concentration of biologically active
constituents varies with the stage of plant growth and
development.
• The period of growth or development at which medicinal
activity is highest has been carefully determined for many
plants. The proportion, of alkaloid in the leaves of Hyocyamus
Niger and of belladonna is largest at the beginning of
flowering, whilst with Stromonium the peak coincides with full
bloom.
• Example:
• Stromonium leaves, gathered in the morning, contain a higher
proportion of alkaloids than those collected in the evening.
Collection of drugs
Processing of crude drugs
Primary processing:
Harvested or collected raw medicinal plant materials
should be promptly unloaded and unpacked upon arrival
at the processing facility. Prior to processing, the
medicinal plant materials should be protected from rain,
moisture and any other conditions that might cause
deterioration. Medicinal plant materials should be
exposed to direct sunlight only where there is a specific
need for this mode of drying.
Medicinal plant materials that are to be used in the fresh
state should be harvested/collected and delivered as
quickly as possible to the processing facility in order to
prevent microbial fermentation and thermal degradation.
Processing of crude drugs
• The materials may be stored under refrigeration, in jars, in
sandboxes, or using enzymatic and other appropriate
conservation measures immediately following
harvest/collection and during transit to the end-user. The
use of preservatives should be avoided if used, they should
conform to national and/or regional regulations for
growers/collectors and end-users.
• Medicinal plant materials that are to be employed fresh
should be stored under refrigeration, in jars, in sandboxes,
or using enzymatic or other appropriate conservation
measures, and transported to the end-user in the most
expeditious manner possible.
• The use of preservatives should be avoided. If used, this
should be documented and they should conform to national
and/or regional regulatory requirements in both the source
country and the end-user country.
Processing of crude drugs

• All medicinal plant materials should be inspected during

the primary-processing stages of production, and any
substandard products or foreign matter should be
eliminated mechanically or by hand.
• For example, dried medicinal plant materials should be
inspected, sieved or winnowed to remove discolored,
mouldy or damaged materials, as well as soil, stones and
other foreign matter. Mechanical devices such as sieves
should be regularly cleaned and maintained.
• All processed medicinal plant materials should be
protected from contamination and decomposition as well
as from insects, rodents, birds and other pests, and from
livestock and domestic animals.
Processing of crude drugs
Specific Processing:
• Some medicinal plant materials require specific processing
to: improve the purity of the plant part being employed;
reduce drying time; prevent damage from mould, other
microorganisms and insects; detoxify indigenous toxic
ingredients; and enhance therapeutic efficacy.
• Common specific processing practices include pre ­
selection, peeling the skins of roots and rhizomes, boiling
in water, steaming, soaking, pickling, distillation,
fumigation, roasting, natural fermentation, treatment with
lime and chopping. Processing procedures involving the
formation of certain shapes, bundling and special drying
may also have an impact on the quality of the medicinal
plant materials.
Processing of crude drugs
• Antimicrobial treatments of medicinal plant materials
(raw or processed) by various methods, including
irradiation, must be declared and the materials must be
labelled as required.
• Only suitably trained staff using approved equipment
should carry out such applications, and they should be
conducted in accordance with standard operating
procedures and national and/or regional regulations in
both the grower/collector country and the end-user
country. Maximum residue limits, as stipulated by
national and/or regional authorities, should be
respected.
Harvesting of crude drugs

• 1. Medicinal plants/herbal drugs should be harvested when

they are at the best possible quality for the proposed use.
• 2. Damaged plants or parts plants need to be excluded.
• 3. Medicinal plants/herbal drugs should be harvested under
the best possible conditions avoiding wet soil, dew, rain or
exceptionally high air humidity. If harvesting occurs in wet
conditions possible adverse effects on the medicinal
plant/herbal drug due to increased moisture levels should
be counteracted.
• 4. Cutting devices or harvesters must be adjusted such that
contamination from soil particles is reduced to a minimum.
Harvesting of crude drugs

• 5.The harvested medicinal plant/herbal drug should not

come into direct contact with the soil. It must be promptly
collected and transported in dry, clean conditions.
• 6. During harvesting, care should be taken to ensure that no
toxic weeds mix with harvested medicinal plants/herbal
drugs.
• 7. All containers used during harvesting must be clean and
free of contamination from previous harvests. When
containers are not in use, they must be kept in dry
conditions free of pests and inaccessible to mice/rodents,
livestock and domestic animals.
Harvesting of crude drugs

• 8. Mechanical damage and compacting of the harvested

medicinal plant/herbal drug that would result in undesirable
quality changes must be avoided. In this respect, attention
must be paid to
• (a) overfilling of the sacks,
• (b) Stacking up of sacks.
• 9. Freshly harvested medicinal plants/herbal drugs must be
delivered as quickly as possible to the processing facility in
order to prevent thermal degradation.
• 10. The harvested crop must be protected from pests,
mice/rodents, livestock and domestic animals. Any pest
control measures taken should be documented.
Drying of crude drugs

• When medicinal plant materials are prepared for use in

dry form, the moisture content of the material should be
kept as low as possible in order to reduce damage from
mould and other microbial infestation.
• Medicinal plants can be dried in a number of ways:
• 1. In the open air (shaded from direct sunlight);
• 2. Placed in thin layers on drying frames, wire-screened
rooms or buildings.
• 3. By direct sunlight, if appropriate.
• 4. In drying ovens/rooms and solar dryers.
• 5. By indirect fire; baking; lyophilization; microwave; or
infrared devices.
Drying of crude drugs

• 6. Vacuum drying
• 7. Spray dryer: Examples: Papaya latex and pectin’s, etc.
• When possible, temperature and humidity should be
controlled to avoid damage to the active chemical
constituents. The method and temperature used for drying
may have a considerable impact on the quality of the resulting
medicinal plant materials.
• For example, shade drying is preferred to maintain or
minimize loss of colour of leaves and flowers; and lower
temperatures should be employed in the case of medicinal
plant materials containing volatile substances. The drying
conditions should be recorded. In the case of natural drying in
the open air, medicinal plant materials should be spread out in
thin layers on drying frames and stirred or turned frequently..
Drying of crude drugs
• Drying medicinal plant material directly on bare ground
should be avoided. If a concrete or cement surface is used,
medicinal plant materials should be laid on a tarpaulin or
other appropriate cloth or sheeting. Insects, rodents, birds
and other pests, and livestock and domestic animals should
be kept away from drying sites.
• For indoor drying, the duration of drying, drying temperature,
humidity and other conditions should be determined on the
basis of the plant part concerned (root, leaf, stem, bark,
flower, etc.) and any volatile natural constituents, such as
essential oils.
• If possible, the source of heat for direct drying (fire) should
be limited to butane, propane or natural gas, and
temperatures should be kept below 60°C. If other sources of
fire are used, contact between those materials, smoke and
medicinal plant material should be avoided.
Storage of crude drugs

• 1. Storage facilities for medicinal material should be

well aerated, dry and protected from light, and, when
necessary, be supplied with air-conditioning and
humidity control equipment as well as facilities to
protect against rodents, insects and livestock.

• 2. The floor should be tidy, without cracks and easy to

clean. Medicinal material should be stored on shelves
which keep the material a sufficient distance from the
walls; measures should be taken to prevent the
occurrence of pest infestation, mould formation, rotting
or loss of oil; and inspections should be carried out at
regular intervals.
Storage of crude drugs
• 3. Continuous in-process quality control measures should be
implemented to eliminate substandard materials,
contaminants and foreign matter prior to and during the
final stages of packaging. Processed medicinal plant
materials should be packaged in clean, dry boxes, sacks, bags
or other containers in accordance with standard operating
procedures and national and/or regional regulations of the
producer and the end-user countries.
• 4. Materials used for packaging should be non-polluting,
clean, dry and in undamaged condition and should conform
to the quality requirements for the medicinal plant materials
concerned. Fragile medicinal plant materials should be
packaged in rigid containers.
Storage of crude drugs
• 5. Dried medicinal plants/herbal drugs, including
essential oils, should be stored in a dry, well-aerated
building, in which daily temperature fluctuations are
limited and good aeration is ensured
• 6. Fresh medicinal plant materials should be stored at
appropriate low temperatures, ideally at 2-8°C; frozen
products should be stored at less than -20°C.
• 7. Small quantity of crude drugs could be readily stored
in air tight, moisture proof and light proof container such
as tin, cans, covered metal tins or amber glass
containers.
• 8. Wooden boxes and paper bags should not be used
for storage of crude drugs.
Quality control of drugs
•The standardization of Herbal Medicine for quality,
emphasizes the standardization of herb medicinal
substances/materials and preparations and that of Herbal
Medicine substance. The morphological identification and
microscopic identification are utilized to determine the
authenticity of Herbal Medicine s whereas the physical and
chemical characters are used to evaluate the quality of
herbs in the existing quality standards.
•The fingerprint analysis has been internationally accepted
as one of the efficient methods to control the quality of
Herbal Medicines. Chemical fingerprint is used to analyze
the chemical constituents in Herbal Medicines, consisting
chromatographic fingerprint, such as thin layer
chromatography (TLC), high performance liquid
chromatography (HPLC), gas chromatography (GC).
Quality control of drugs
Quality control of drugs
Quality control of drugs
Quality control of drugs
 Evaluation of crude drugs
• Evaluation means confirmation of its identity and
determination of quality and purity of the herbal drug.
Evaluation of plant drug materials is necessary
because of three main reasons: biochemical variations
in the drug, deterioration due to treatment and storage,
substitution and adulteration as a result of
carelessness, ignorance or fraud or variability caused
by differences in growth, geographical location, and
time of harvesting. For the quality control of a traditional
medicine, the traditional methods are procured and
studied, and documents and the traditional information
about the identity and quality assessment are
interpreted in terms of modern assessment or
monograph in herbal pharmacopoeia
Evaluation of crude drugs

• It is obvious that the content is the most difficult one to

assess, since in most herbal drugs the active
constituents are unknown. Sometimes markers can be
used which are, by definition, chemically defined
constituents that are of interest for control purposes,
independent of whether they have any therapeutic
activity or not. To prove identity and purity, criteria such
as type of preparation sensory properties, physical
constants, adulteration, contaminants, moisture, ash
content and solvent residues have to be checked. The
correct identity of the crude herbal material, or the
botanical quality, is of prime importance in establishing
the quality control of herbal drugs
Evaluation of crude drugs
• Identity can be achieved by macro- and microscopical
examinations. Voucher specimens are reliable
reference sources. Outbreaks of diseases among
plants may result in changes to the physical
appearance of the plant and lead to incorrect
identification.
• Purity is closely linked with the safe use of drugs and
deals with factors such ash values, contaminants (e.g.
foreign matter in the form of other herbs), and heavy
metals. However, due to the application of improved
analytical methods, modern purity evaluation includes
microbial contamination, aflatoxins, radioactivity, and
pesticide residues.
Evaluation of crude drugs

• Content or assay is the most difficult area of quality

control to perform, since in most herbal drugs the active
constituents are not known. Sometimes markers can be
used. In all other cases, where no active constituent or
marker can be defined for the herbal drug, the
percentage extractable matter with a solvent may be
used as a form of assay, an approach often seen in
pharmacopeias. The choice of the extracting solvent
depends on the nature of the compounds involved, and
might be deduced from the traditional uses.
Evaluation of crude drugs

• The plant drug materials can be evaluated or identified by

five methods:
• Organoleptic evaluation or morphological evaluation
• Microscopic evaluation
• Physical & Proximate values evaluation
• Chemical evaluation
• Chromatography and chemical fingerprints of herbal
medicines
• Biological evaluation
• Radioimmunoassay
Evaluation of crude drugs
Adulteration

• The term adulteration is defined as substituting

original crude drug partially or wholly with other
similar-looking substances. The substance, which is
mixed, is free from or inferior in chemical and
therapeutic property.
• The adulteration is done deliberately, but it may
occur accidentally in some cases.
• Adulteration involves different conditions such as
deterioration, admixture, sophistication,
substitution, inferiority and spoilage.
Types of Adulterants

• Deterioration is impairment in the quality of drug,

whereas admixture is addition of one article to
another due to ignorance or carelessness or by
accident.
• Sophistication is the intentional or deliberate type
of adulteration.
• Substitution occurs when a totally different
substance is added in place of original drug.
• Inferiority refers to any substandard drug, and
spoilage is due to the attack of microorganisms.
Types of Adulterants

Unintentional Adulteration :
Unintentional adulteration may be due to the
following reasons:
Confusion in vernacular names between indigenous
systems of medicine and local dialects, lack of
knowledge about the authentic plant, no availability
of the authentic plant, similarity in morphology and
or aroma, careless collection, other unknown
reasons, Name confusion.
Types of Adulterants

Intentional Adulteration :
Intentional adulteration may be due to the following
reasons:
• Adulteration using manufactured substances : In this
type of adulteration, the original substances are
adulterated by the materials that are artificially
manufactured. The materials are prepared in a way that
their general form and appearance resemble with
various drugs. For example, Paraffin wax is colored
yellow and is been substituted for beeswax, and
artificial invert sugar is used in place of honey.
Types of Adulterants

• Substitution using inferior commercial varieties

• In this type, the original drugs are substituted using inferior
quality drugs that may be similar in morphological
characters, chemical constituents or therapeutic activity.
• For example, hog gum or hog tragacanth for tragacanth gum,
mangos teen fruits for bael fruits, Arabian Senna, obovate
senna and Provence senna are used to adulterate senna,
ginger being adulterated with Cochin, African and Japanese
ginger. Capsicum annuum fruits and Japanese chillies are
used for fruits of C. minimum.
Types of Adulterants
• Substitution using exhausted drugs
• In this type of substitution, the active medicaments of the
main drugs are extracted out and are used again. This could
be done for the commodities that would retain its shape and
appearance even after extraction, or the appearance and
taste could be made to the required state by adding coloring
or flavoring agents. This technique is frequently adopted for
the drugs containing volatile oils, such as: clove, fennel etc.
After extraction, saffron and red rose petals are recolored by
artificial dyes.
Types of Adulterants

• Substitution of superficially similar inferior natural

substances
• The substituents used may be morphologically similar but
will not be having any relation to the genuine article in their
constituents or therapeutic activity. Ailanthus leaves are
substituted for belladonna, senna, etc. saffron admixed with
saff flower; peach kernels and apricot kernels for almonds;
clove stalks and mother cloves with cloves; peach kernel oil
used for olive oil; chestnut leaves for hamamelis leaves and
Japan wax for beeswax are few examples for this type of
adulteration.
Types of Adulterants
• Adulteration using the vegetative part of the same plant
• The presence of vegetative parts of the same plant with the
drug in excessive amount is also an adulteration. For example,
epiphytes, such as mosses, liverworts and lichens that grow
over the barks also may occur in unusual amounts with the
drugs, e.g. cascara or cinchona. Excessive amount of stems in
drugs like lobelia, stramonium, hamamelis leaves, etc. are few
example for this type of adulteration.
• Adulteration of powder
• Powdered drugs are found to be adulterated very frequently.
Adulterants used are generally powdered waste products of a
suitable color and density. Powdered olive stones for
powdered gentian, liquorice or pepper; brick powder for barks;
red sanders wood to chilies; dextrin for powder
• 
Types of Adulterants
• Addition of toxic materials
• In this type of adulteration, the materials used for
adulteration would be toxic in nature. A big mass of stone
was found in the center of a bale of liquorice root. Limestone
pieces with asafetida, lead shot in opium, amber-colored
glass pieces in colophony, barium sulphate to silver grain
cochineal and manganese dioxide to black grain cochineal,
are few examples in this adulteration.
• Addition of synthetic principles
• Synthetic pharmaceutical principles are used for market and
therapeutic value. Citral is added to lemon oil, whereas
benzyl benzoate is added to balsam of Peru. Apart from
these, the herbal products labelled to improve sexual
performance in men, when analyzed, contained sildenafil.