STANDARDIZATION AND QUALITY CONTROL OF HERBAL DRUGS.pptx

STANDARDIZATIONAND
QUALITYCONTROLOFHERBAL
DRUGS

Introduction of Herbal drugs
 Herbal products have been used since long times as medicine/drug for the
treatment of a numerous diseases.
 The basic resources of medicine come from nature and they are used as
medicaments since from ancient time till today.
 Each plants is like bio-factory which is capable of synthesizing infinite number of
highly complex and unusual chemical substances which posses pharmacological
or other excipients aid which is called as metabolites.
 There are at least more than 120 different chemical substances originated from
plants that are considered as important drugs currently in use in the world.
 WHO has delivered some terms related to herbal drugs, according to their
definitions. Herbal medicines include herbs, herbal materials, herbal
preparations and finished herbal products.

 During the ancient time traditional medicine as include diverse health practices,
knowledge and beliefs, spiritual therapies, manual technique and exercises
practice are applicable singularly or in combination to maintain well being as
well as diagnosis or prevent illness.
 As according to ancient civilization and development this herbal drugs are
utilize for health care applied in indigenous system of medicine like in –
Ayuveda, Siddha and Unani, Naturopathy, Chinese med system etc.
 Herbal drugs which are use in cure of illness are utilize or given in crude or raw
state, which is pure in nature and directly intake without formulating or in some
times formulated in simple dosage form.
 The un processed herbal drugs which are obtain from the source lower or higher
plants are known as crude drugs and it is divided on the basis of nature and
appearance.

Types of crude drug’s
Organized crude drugs Unorganized crude drugs
• It consist of a direct parts of the
plant which are made of cell or
definite structure. like leaves,
barks wood, root, rhizome, seed,
fruits, flowers, stem, hair and
fibers etc
• They are appearances in solid
nature.
• Botanical or zoological
terminology can be used to
describe these drugs.
• Microscopic characteristic are one
of the important criteria for
identification.
• Digitalis leaf, cinchona bark, clove
etc.
• It consist of derived product obtain
from plants and animal by process
of extraction and purification. Like
latex, juice, gum, resins, oil and
fat.
• These are solid, semisolid or liquid
in nature.
• Botanical or zoological
terminology are also used for it but
physical character are mainly
applicable like Solubility, density,
optical rotation, refractive index
etc.
• Chemical test and physical
standards are confirmatory test for
identification.
• Aloe-vera flesh, agar, opium,
castor oil, bees wax, enzymes etc.

Cultivation
Drying
- Natural
(sun drying)
- Artificial
(Oven, tray drying,
vacuum drying and
spray drying)
Harvesting
Storage and Packaging
Market sale and
dispensing
Garbling (dressing)
Cultivation, collection and preparation of herbal crude drugs
Sale to herbal preparation
Industry

What are herbal drugs ?
The term “herbal drugs” are denotes that plants and its parts that have been
converted into phyto-pharmaceutical, for therapeutic role by means of simple
processes involving harvesting, drying and storage.

Definition of herbaldrug according toWHO
Are – A finished and labelled products that contains an active ingredients which
are responsible for therapeutic features and it consist of aerial or underground
parts of plant or other plant material, in some time it contains combination,
whether in crude state or a formulation.
Are not– Medicines that containing the combination of plant material along
with chemically defined active substance.
(As defined by World Health Organization)

Classificationof herbal Drug’s
Classification of the herbal drugs are based on the formulation and its dosage state that
are :-
 Phytomedicines or phyto pharmaceuticals sold as over the counter (OTC) product in
modern dosage forms such as tablets, capsules, liquids for oral use etc.
 Dietary supplements containing herbal products, also called as Neutraceutical available in
modern dosage forms which is use for health and fitness.
 Herbal medicines consisting of either crude, semi processed or processed medicinal
product. Ayurvedic formulation and dosage form.
 More over herbal drugs are also divided on the basis of nature and number of drug
composition contain within a formulation.

HERBAL
DRUGS
Mono herbal
Formulation
(Single or
crude drugs)
Poly herbal
Formulation
(multi herbal
drugs)
TYPES OF HERBAL DRUGS
 Mono herbal formulation or (Single or crude drugs) – A formulation
which consist of only single drug which is called as main active ingredient
which posses therapeutic feature. It is simple called as crude drug but some
time it is formulated in dosage form as per need.
 Poly herbal formulation or (multi herbal drugs) – A formulation which
consist of multiple number of herbs drugs and have different
pharmacological feature as according to it requirement for particular
treatment.

Mainly whole, fragmented
or cut plants, parts of plant
in dried form, some times
is taken fresh.
It also include algae, fungi,
lichens other microbes.
Like – Spirulina .
It can be obtain by simple
process like decoction,
maceration.
 Features of Mono herbal Formulation (Single or crude
drugs)

 Features of Poly herbal Formulation (Multi herbs drugs)
 It consist of different medicinal plants and natural excipients, which have
multiple constituents.
 It ability to posses a pharmacological response as per need along with
multiple function.
Poly herbal Formulation anti dandruff herbal Shampoo

What is Quality control ?
 Quality control (QC) is a procedure or set of procedures which evaluate to
ensure that a manufactured or a finished product, performed services adheres
to defined set of quality criteria.
 Quality control (QC) is defined as a procedure or set of procedure or
activities intended to ensure that a quality in products. The activities focus on
identifying the defect in the actual products by specific evaluation
parameter’s.

Identify the
defect
Safety
Efficacy Purity
Content
Good
Laboratory
Practices
Good
Manufacturing
Practices
Standard
as
following
Factor’s Effecting Quality
Control

Role of quality control in herbal drugs
• The role of quality control in herbal drugs is to know the efficacy and safety
of herbal products. It can be define as status of a drug that is determined by
identity, purity, content, and other chemical, physical or biological properties
or by the manufacturing processes.
• It is use to find out the qualitative estimation of adulterate and substitute with
in product.
• Quality control is a term that refers to process which involve in maintaining
the quality and validity of manufactured product.
• In general all the medicines whether they are of synthetic or plant origin,
should fulfill the basic requirements of being efficacious and safe, and this
can be archived by suitable clinical trials.

What is standardization ?
• Standardization means “Standardization is a framework of agreements to which all
relevant parties in an industry or organization must adhere to ensure that all processes
associated with the creation of a good or performance of a service are performed within
set guidelines.”
Standardization of herbal drugs refers to “Confirmation of its identity and
determination of its quality, purity and detection of nature of adulterants by
various parameter like- morphological, microscopical, Physical, chemical and
biological observation.

Standardization and quality evaluation of herbal
drugs
 Standardization of herbal drugs means to confirmation of its identity, quality and
purity.
 Standardization of herbal formulations is essential in order to assess of quality
drugs, based on the concentration of their active principle, physical, chemical,
physcio-chemical standardization and in vitro, in-vivo parameters.
 It is necessary to maintain reproducible efficacy and safety of phyto-pharmaceutical
therefore, if phyto-pharmaceutical have to regards as rational drug should be
standardized and pharmaceutical quality must be approved.
 WHO (World Health Organization), ICH (International Council of Harmonization)
and EU (European union) these are research guidelines for Evaluating the Safety
and Efficacy of Herbal Medicines, which design a protocol and standard guidelines
for evaluation studies.

Classification ofherbal drugstandardization

Standardization and Quality control
of Herbal drugs
Botanical Method Physical Method
Chemical Method
Instrumental Method Biological Method
1. Macroscopical (Morphological
studies)
2. Microscopical (Histological studies)
The qualitative chemical tests are useful
in identification of chemical constituents
and detection of adulteration.
• Moisture contain
• Ash value
• Extractive value
• Viscosity
• Density
• Solubility
• Bitterness value
• Swelling index
• Foaming index
• Specific gravity
• Spectroscopical analysis
• Chromatography analysis
• Isolation organs of living animal
• Animal modal studies
• Microbial modal

Macroscopic method evaluation
• It initial examination of the drugs which can be used to identify the physical
appearance of organized and unorganized drugs by sensory characters.
• Its refer to evaluation of drugs by colour, odour, taste, shape and size, special
characteristic like touch, texture, fracture, sound, aroma etc. It also classify the
organized or unorganized nature of herbal drug
• This method is very common which is also called as morphological evaluation.
• It is use to evaluate the adulteration and substitution of crude drug by sensory
examination.
• It also give the information regarding the agriculture practices of crude drug and
factor which influences the cultivation and collection.
• Eg. Wood fractured surfaces in cinchona, quillaia and cascara barks and quassia
Aromatic odour of umbelliferous fruits and sweet taste of liquorice. 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, cumin etc. are important diagnostic organoleptic characteristics.

Macroscopic method evaluation
Asafoetida (Ferula foetida)
• Synonyms – Asafoetida , devil drug
• Bio source – olea-gum resin obtain by
making incision in rhizome or root of
ferula foetida
• Family - Umbelliferae
• Organoleptic (Morphological) feature :-
Morphological feature Description
Colour Yellowish –white changing to reddish brown
Odour Aromatic and persistent
Taste Bitter and acidic
Shape Tears are 0.5 to 3 cm
Size Lumpy mass, round and irregular

Microscopical method evaluation
• It involves detailed examination of the drugs and it can be used to identify the
organized drugs by their known histological characters.
• It is mostly used for qualitative evaluation of organized crude drugs in entire
which help for detecting various cellular tissues like trichome’s, stomata, starch
granules, calcium oxalate crystals and aleuronic grains etc.
• Starch and hemicelluloses is identified by blue color with iodine solution,
lignified tissues give pink strain with phloroglucinol and HCl etc.
• mucilage is stained pink with ruthenium red can be used to distinguish cellular
structure.
• Quantitative aspects of microscopy includes study of stomata number and index,
palisade ratio, vein islet number, size of starch grains, length of fibers etc. Which
plays a very important role in the identification of drug.

Transverse section of datura leaf
Transverse section of Fennel fruit
Longitudinal of Cinnamon
bark

Microscopical method also consist of microscopic linear measurement and
quantitative microscopy are also covered under this technique of evaluation.
The following microscopical measurement are :-
a. Stomatal number – It is the average number of stomata present in per square
mm of the epidermis.
b. Stomatal index- It is a percentage which the number of stomata form to the
total no. of epidermal cells, each stoma counted as one cell. It can be
calculated by formula.
I = S x 100
(E+S)
I – stomatal index, S – No. of stoma per unit area, E- epidemal cells in same area
c. Vein islet number- The no. of vein islet present in per sq mm of leaf surface.
d. Palisade ratio- The Avg no. of palisade cells, present on one epidermal cell.

Stomatal number:-
Datura stramonium – 87 stomatal no.
Hyoscyamus niger – 125 stomatal no.
Stomatal index:-
Atropa belladonna – 20.2 to 23.0
Indian senna – 17.0 to 20.2
Vein islet number:-
Digitalis purpurea – 02 to 5.5
Cassia angustifolia – 19 to 23
Palisade ratio:-
Atropa belladonna – 06 to 10
Digitalis purpurea – 3.7 to 4.5

Chemical method evaluation
e. Identification test for tannin:-
- ferric chloride test
- Gold beater skin test
- Gelatin sol and sodium chloride solution test
f. Identification test for Carbohydrate:-
- Molish reagent test – α napthnol solution test
- Fehling solution test

Most of drugs have definite chemical constituents to which their biological or
pharmacological activity is attributed. Qualitative chemical test are used to identify
certain drug or to test their purity. Isolation , purification, identification of active
constituents is based on chemical methods of evaluation.
 Evaluation test of resins : acid value, sulphated ash
 Evaluation test of balsams: acid value, saponification value, bester values.
 Evaluation test of volatile oils : acetyl and ester values
This covers screening, isolation, identification and purification of the chemical components.
Chemical analysis of the drug is done to assess the potency of vegetable material in terms of
its active principles. The chemical screening or tests may include colour reaction test, which
help to determine the identity of the drug substance and possible adulteration.

a. Identification test for alkaloids:-
- Mayer’s reagent (Potassium mercuric iodide sol)
- Dragendroff’s reagent (Potassium bismuth iodide sol)
- Wagner’s reagent (iodine and potassium iodide sol)
- Hager’s reagent (Sat sol of picric acid)
b. Identification test for glycoside:-
- Saponin test
- Cyanophoric test
- keller Killiani test
c. Identification test for Volatile oil:-
- Alcoholic sol of Sudan III dye test
- Alkana tincture test
d. Identification test for fixed oil and fats:-
- Sodium hydroxide test
- Sodium hydrogen sulphate test
- Alcoholic solubility test

Active
constituent
of
Herbs
Alkaloid
Glyco-
side
Resins
Tannin
Volatile
oil
Terpanoi
-ds
Lipids
and fatty
acids,
wax
Carbohy
-drates
Bio-
pesticid
es
Active constituents which are present in herb or herbal product

Primary
Metabolites
carbohydrates
Proteins
Lipids
Nucleic
acids
Hormones
Secondary
metabolites
Alkaloids
Glycosides
Phenolic
compound
Terpenoids
Metabolites of plants

Physical method evaluation
Physical constants are sometimes taken into consideration to evaluate certain drugs.
These include moisture content, specific gravity, optical rotation, refractive,
melting point, viscosity and solubility in different solvents.
All these physical properties are useful in identification and detecting of physical
nature of constituents present in plants.
1) Moisture content- The moisture content of a drug will be responsible for decomposition
of crude drugs either producing chemical change or microbial growth. So, the moisture
content of a drug should be determined and controlled. The moisture content is
determined by heating a drug at 105o c in an oven to a constant weight.
E.g. The moisture content of digitalis and ergot should not be more than 5%W/W,
respectively.

2) Solubility- Drug constituents have specific behaviour towards solvents are taken into
consideration.
Eg. Solubility of colophony of colophony in light petroleum, the solubility of balsam of
Peru in solution of chloral hydrate.
3) optical rotation- An isotropic crystalline solids and samples containing an excess of
one enantiomer of a chiral molecule can rotate the orientation of planepolarized light.
Such substances are said to be optically active, and this property is known as optical
rotation. Eg. Eucalyptus oil (0o c to +10o c), honey (+3o c to -15o c)
4) Refractive index-It is defined as the property of a material that changes the speed of
light, computed as the ratio of the speed of light in a vacuum to the speed of light
through the material. when light travels at an angle between two different materials,
their refractive indices determine the angle of transmission refraction of the light beam
E.g. castor oil 1.4758-1.527

5) Specific gravity- It is also known as relative density. The ratio of the mass of a
solid or liquid to the mass of an equal volume of distilled water at 4o c(39o F) or of
a gas to an equal volume of air or hydrogen under prescribed conditions of
temperature and pressure.
Eg. Specific gravity of drugs are cottonseed oil 0.88-0.93, coconut oil 0.925, castor
oil o.95,etc.
6) Viscosity- Viscosity of a liquid is constant at a given temperature and is an index
of its composition. Eg. pyroxylin kinematic viscosity, 1100-2450 centistokes.
7) Melting point- Plant constituents have very sharp and constant melting points.
As far as crude drugs are concerned, melting point range has been fixed due to the
mixed chemicals. Eg. Beeswax 62-65o c,wool fat 34-44o c
8) Ultraviolet light Certain drugs fluorescence when the cut surface or the powder
is exposed to ultraviolet radiation, and it is useful in the identification of those
drugs.
Eg. Some pieces of rhapontic, Indian and Chinese rhubarb are very difficult to
distinguish, and it is very difficult in powdered form, but examination in ultraviolet
light gives such marked differences in fluorescence that the varieties can be easily
distinguished from each other.

9.) Ash value- The residue remaining after incineration is the ash content of the
drug. Significance- Ash value is an important parameter to prove acceptability and
purity in case of drugs that are collected or stored by incorrect way. High ash value
is indicative of contamination, substitution, adulteration in crude drug.
E.g. Inorganic salts, naturally occurring in drug in the form of adulteration. Ash
value is determinant of identity or purity of drug
a. Acid insoluble ash: It determines amount of silica present, especially as sand
siliceous earth
b. Water soluble ash: It determines the amount of water soluble constituents in
crude drug like tannin, sugar, plant acids, mucilage, glycoside etc.

10) Extractive values- The extracts obtained by exhausting crude drugs with
different solvents are approximate measures of their chemical constituents. Various
solvents are used according to the type of the constituents to be analysed.
- “Water soluble extractive” is used for crude drugs containing water-soluble
constituents like glycosides, tannins, mucilage etc;
- “Alcohol- soluble extractive” is used for crude drugs containing tannins,
glycosides, resins, etc.
- “Ether-soluble extractives” are used for drugs containing volatile constituents and
fats.
11) Foreign organic Matters- The parts of the organ or organs other than those
parts of drugs mentioned in the definition and description of the drug are known as
foreign organic matters. They may be insect, moulds, earthy material, animal
excreta, etc. E.g. Garlic should not contain more than 2%, saffron should not
contain more than 2%.

Biological method evaluation
• When the estimation of potency of crude drug or its preparation is done by means
of its effect on living organisms like bacteria, fungal growth or animal tissue or
entire animal, it is known as bioassay.
• Some drugs have specific biological and pharmacological activity which is utilized
for their evaluation. Actually this activity is due to specific type of constituents
present in the plant extract. For evaluation the experiments were carried out on
both intact and isolation organs of living animals. With the help of bioassays,
strength of drug in its preparation can be evaluated.
• Biological evaluation or bioassay can be carried out on following living creature’s
like- microbial strain (bacteria, fungus, protozoa or virus), aquatic animal (zebra
fish), developed mammals (swiss albino mice, wistar albino rat, guniea pigs,
himalayan white rabbit, cat, dogs and monkeys), bird (Pigeon).

Living models use for biological evaluation
Fungal strain Bacterial strain
Guniea pig
Swiss albino mice
Wistar albino mice
Albino Rabbit Zebrafish (Danio rerio)
Pigeon

Instrumental method evaluation
• Instrumental method of analysis is one of the important and advance part of
quality control and standardization of herbal drug in analytical pharmacognosy.
• It consist to find identity, purity, content percentage and concentration of the
product with respect of quality.
• This method is consist of various instrumental tools and technique to check the
quality control and standardization of herbal drugs.
• This method is use when the all the evaluation parameter gets fail to predict the
quality report the instrumental use for it to know the chemical and physical
parameters and quality check
• Instrumental analytical technique using instrumental techniques such as thin
layer chromatography, HPLC, GC–MS, LC–MS, Infrared (IR), and
spectrophotometer, etc.

Chromatography
technique
Thin layer
chromatography
(TLC)
High performance
thin layer
chromatography
(HPTLC)
High performance
liquid
chromatography
(HPLC)
Liquid
chromatography –
mass spectroscopy
(LC-MS)
Gas
chromatography –
mass spectroscopy
(GC-MS)
Spectroscopy
technique
Ultra voilet
spectroscopy
(UV-visible)
Infra red
Spectroscopy (IR)
Mass
Spectroscopy
(MS)
Nuclear Magnetic
resonance (NMR)
Instrumental method of quality
control

• SPECTROSCOPICALANALYSIS:-
I. Uv-visible spectroscopy – UV/Vis spectroscopy is routinely used in analytical for
the quantitative determination of different analytes, such as transition metal ions,
highly conjugated organic compounds, and biological macromolecules.
Spectroscopic analysis is commonly carried out in solutions but solids and gases
may also be studied.
II. Mass spectroscopy - can be used to classify unknown substances by molecular
weight measurement, to measure known compounds, and to determine the structure
and chemical properties of molecules. Due to its capability to distinguish between
substances, Mass spectrometry is used to determine unknown substances.
III. Infrared spectroscopy ( IR spectroscopy or vibrational spectroscopy) is the
measurement of the interaction of infrared radiation with matter by absorption,
emission, or reflection. It is used to study and identify chemical substances or
functional groups in solid, liquid, or gaseous forms.
IV. NMR spectroscopy has many applications in modern science. As we’ve explored,
its primary function is analysing molecule structure and shape. However, it is also
used for the following purposes like determining protein folding, drug screening
and design.finding out how molecules interact in chemical reactions, determining
the proportion of solids and liquids in lipids.

Example’s of herbal drug represent Spectroscopic response
• Examples of drugs with their uv-visible wavelength :-
Herbal drugs UV range (nm)
Morphine 284
Aloe-emodin 225,258,279,287,430
Caffeine 243,326
Scopholine 227,250,288,339
1) Amines - 3300-3500 cm-1
2) Alkanes- 2940-2860 cm-1
3) Carboxylic acid- 3520 cm-1
4) Cynide- 2225 cm-1
5) Hydroxyl- 3400-3500 cm-1
• Examples of drugs with their IR frequency :-

• CHROMATOGRAPICALANALYSIS:-
1 Thin Layer Chromatography TLC is one of the most important tool for separation of
compound. It is widely used technique of chromatography. It is based on principle of
adsorption . In this method stationary phase is a finely divided solid and it is applied as a thin
layer on supporting plate and the mobile phase is a liquid which is allowed to flow on the
surface of the plate by capillary action. Common adsorbent material used- Silica gel, Alumina,
Kieselguhr.
Drug Adsorbent Solvent system
Rauwolfia alkaloids Silica gel 60 F254 Ethyl acetate: Methanol:
Water (100:13.5:10)
Colchicum alkaloids Silica gel 60 F254 Ethyl acetate: Methanol:
Water (100:13.5:10)
Founiculum valgare Silica gel 60 Tolune:Ethyl acetate(93:7)

.2 HPTLC: In High Performance Thin Layer Chromatography a layer thickness of 100-150
micron is used to achieve separation. HPTLC uses open layers of adsorbents on plates or foils to
separate component of samples but the quantification is observe under the UV visible chamber to
observe the spot of absorbance.
Significance of HPTLC: Identification and detection of adulterants in herbal product and it is also
important in identification of pesticide content, myco-toxins and in quality control of herbs and
health foods
Drug Example - Flavonol Glycosides.
Stationary Phase: Silica gel
Mobile Phase: Chloroform: Benzene: Ethanol: Acetic acid: Water (11:4:2:1:2)
Detection: Spraying with 8% AlCl3 in ethanol.
Quantification: UV absorbance 370nm.

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