MONOGRAPHS OF HERBAL DRUGS

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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
A Seminar as a part of curricular requirement
for I year M. Pharmacy II semester.
Presented by
Mr P. Sudheer kumar
(Reg. No. 20L81S0712)
Under the guidance of
G. Kranthi kumar sir;
Assistant Professor Pharmaceutical Analysis.
MONOGRAPHS OF HERBAL DRUGS

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Introduction
• Indian pharmacopoeia
• Ayurvedic pharmacopeia
• United states pharmacopeia

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• Various countries have published texts, to assure drug quality which
is design as collection.
• EXAMPLES:
• Indian Pharmacopeias
• United state Pharmacopeias
• Ayurvedic pharmacopeia
Pharmacopoeia:
Definition “Pharmacopoeia is a book or encyclopedia of Drugs
Standard, their formulas, Method for making medicinal preparation
and related information's which is published under the jurisdiction of
government body”
Introduction:

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MONOGRAPHS
• Monographs set forth the articles name, definition,
• Specification, and other requirements related to packaging,
• Storage, and labelling.
• The specification consists of tests, procedures, and acceptance
criteria that help ensure the identity, strength , quality and purity of
the article. for general requirements
• Relating to specific monograph sections, see section 5,
monograph components. because monographs may not provide
standards for all
• Relevant characteristics, some official substance may conform to
the USP or NF standard but differ with regard to non-standardized
properties that are relevant to their use in
• Specific preparation.

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MONOGRAPH COMPONENTS
• Molecular formula
• Named in defining the required strength of compendial article
intended chemical entity as given in the complete chemical name of
the artiAdded substances
• Added substances are presumed to be unsuitable for inclusion in an
official article and therefore prohibited, if their presence impairs the
bioavailability.
• 1. The use of the molecular formula for the active ingredient
• 3.Added substance (official substances)
• May contain only the specific added substances that are permitted by
the individual monograph. They are not exceed the quantity for
providing their intended effect.

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Added substances(Excipients and ingredients)
• suitable substances and excipients such as antimicrobial agents,
• Pharmaceutical bases, carriers, coating .
• Compounded preparations
• Compounded preparations for which a complete composition is
• Given shall contain only the ingredients named in the formulas
• Or in the individual monograph.
• Dietary supplements
• Additional ingredients may be added to dietary supplement products
provided that the additional ingredients.

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• Description and solubility
• Identity
• Assay
• Units of potency
• Impurities and foreign substances
• Residual solvents
• Elemental impurities
• Performance tests

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INDIAN PHARMACOPEIA:
• Introduction
• Definition:
• As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia
is the legally recognized book of Standards for the quality of drug
substances and preparations included therein for INDIA.
• Indian Pharmacopoeia was prepared by Indian Pharmacopoeia
Commission(IPC).
• Formation The Indian Pharmacopoeia Commission has been
established as an Autonomous Institution under Ministry of Health &
Family Welfare, Government of India on 09th Dec. 2004.

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CASSIA FISTULA
• Drug consists of fruits of cassia fistula linn.
• Fam.fabaceae.
• The plant is found throughout india in all deciduous forests and hilly tracts.
It is cultivated as an ornamental plant for its beautiful Yellow flowers. Apart
from the fruit. the other parts used are root, root bark, flowers and leaves.
OTHER NAMES
Beng. -Aragvadha
Guj. -Garmal
Hindi -Amaltas
Kan. -kakke,konne
Punj. -Alash
Tel. -Rela
Tam. -konnai

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 MACROSCOPIC
1. The fruits pods are 40-70cm long and 20-27mm in diameter.
Straight or slightly curved, smooth but finely striated transversely, the
striations appearing as fine fissures.
2. The rounded distal end bears a small point marking the position of
the style. the dorsal suture appears as a single vascular strand and the
ventral suture appears as a single vascular strand and the ventral suture
as two closely applied strands.
3. Internally the pod is divided by thin , buff coloured ,transverse
dissepiments at intervals of about 0.5cm.
4. The pulp has a sweetish - taste and characteristic odour
DESCRIPTION

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1. The pericarp about 1.5mm thick, shows the presence of epicarp,
mesocarp and endocarp.
2. Epicarp is made up of a single layer of brownish coloured
rectangular cells.
3. Mesocarp is composed of polygonal thin walled parenchymatous
cells and endocarp consists of many layers of stone cells of varying
shapes and sizes .
4, Vascular elements present in the mesocarp are composed of small
tracheids (104µ-130µ in length and 13µ-20µ in breadth)and long
tracheids.
MICROSCOPIC

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CHEMICAL CONSTITUENTS
MAJOR: Glycosides –anthraquinone derivatives
Rhein; Hydroxymethyl anthroquinones; sennosides A, B; Barbaloin.
MINOR: oxymethyl anthraquinone and fistulic acid;An oil,5-
nonatetracontanone, 2-hentriacontanone, tricontane, 16-hentriacontanol
and β-sitosterol

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• COLOUR REACTION
Borntraeger test for anthraquinone glycosides.
Boil aqueous extract of the drug with dilute HCL, Cool and extract
with chloroform. Shake chloroform extract with dilute ammonia
solution. Ammoniacal layer takes pink to red colour.
ASSAY/ANALYTICAL METHOD
Determination of sennosides by UV spectroscopy
• Standard preparation: weigh accurately 100mg of calcium sennosides
• Transfer to a 10 ml of volumetric flask and make to volume with
water
IDENTITY TESTS

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1. From this take 1ml and reflux with 8ml of 25% HCL +2ml of
glacial acetic acid on a boiling water bath for 20 minutes.
2.Transfer the mixture to a separator quantitatively.
3.The mixture is then extracted with 3×30ml fraction of ethyl
acetate and this solution is filtered into 100ml volumetric flask.
From this 25ml of ethyl acetate solution is transferred to a
separator and shaken with two portions of 25 to 20 ml of freshly
prepared saturated sodium bicarbonate solutions.
The ethyl acetate solution is discarded

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4. The combined bicarbonate solution is acidified with 10ml
HCL, then extracted successively with 25 and 20ml ethyl acetate.
The combined ethyl acetate extract is transferred into 50ml
volumetric flask and made to volume.
5.The extinction of the solution is measured against pure solvent
at 370nm and 430nm,and the percentage of total sennosides was
calculated using the formula
Total sennosides content=[A370 X 47.5 – A430 X 18.5] X210.2 / Wt
in mgs
A=absorbance

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• The powdered drug 1g is refluxed with water(40ml)on a boiling
water bath for 2hr.
• Resultant solution is decanted and filterd into a 100ml volumetric
flask.
• The marc is further extracted with 40ml of water for 1hr.the extract
is decanted and filtered into the same volumetric flask.
• the filter paper is washed with warm water and the volume made
up to 100ml. 10ml of this solution is used as test solution. the test
solution is then treated in the same manner as that of standard
solution. the total sennosides content is calculated as per the
formula.
SAMPLE PREPARATION:

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LIMITS FOR QUALITY PARAMETERS
TOTAL ASH : Not more than 6%
ACID INSOLUBLE ASH : Not more than 1%
ALCOHOL SOLUBLE EXTRACTIVE : Not less than 29.5%
WATER SOLUBLE EXTRACTIVE :Not less than 35.5%
LOSS ON DRYING :Not more than 5%

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The fruit is used as
• antibacterial
• Antifungal
• Antihelmintic
• Diuretic
• Antidiarrhoeal.
• The aqueous extract of fruit pulp in a dose of 1g/100g body weight
produces significant anti-inflammatory effect in albino rats.
• The aqueous extract of the fruit pulp has significant purgative
action. The activity is due to the presence of anthraquinones.
Bioassay of cassia fistula has been carried out wherein its cathartic
efficacy has been compared with that of senna.
PHARMACOLOGY

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THERAPEUTIC CATEGORY:
The pulp is cathartic and also used as febrifuge and tonic
DOSAGE:
250mg and above causes catharic action that reaches maximum in
6-9hr and lasts for 24hr

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The Ayurvedic Pharmacopoeia of India
• Official book of standards for single drug and its formulations or
• Compilation of various ayurvedic pharmaceutical formulation(s)
i.e. formulas and methods of preparations .
THE AYURVEDIC PHARMACOPOEIA OF INDIA

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 Assam : sonaroo
 Guj. : garmala garmalo
 Hindi : amaltas
 Kan. : aragvadha, kakke,
DESCRIPTION:
Macroscopic-
1. Fruit, a many called, indehiscent pod, 35-60cm long and 18-25 mm
in diameter, nearly straight and sub-cylindrical, chocolate-brown to
almost black in colour: pod surface smooth to naked eye,
2. Pericarp thin, hard and woody; fruit initially divided by transverse
septa about 5mm,apart each counting a single seed attached to ventral
suture by a long dark, thread–like funicle about 8-12 by 6-8mm,circular
to oval flatted.
SYNONYMS

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3. Reddish-brown, smooth, externally hard and with a distinct dark
brown line extending from micropyle to base: seed initially embedded
in a black viscid pulp consisting of black, thin, shining, circular disc
like masses having central depression of seed on both surfaces or as
broken pieces adhered with each other .
4. when dipped in water, makes yellow solution which darkness to
brownish-yellow to dark brown, on keeping : pulp fills the cells but
shrinks on drying and adheres to both sides of testa; seeds often lye
loose in their segments: odour faint, sicky; taste ,sweet.

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 FOREIGN MATTER -Not more than 2 %
 TOTAL ASH - Not more than 6%
 ACID-INSOLUBLE ASH -Not more than 1%
 ALCOHOL-SOLUBLE EXTRACTIVE -Not less than 15%
 WATER-SOLUBLE EXTRACTIVE -Not less than 46%
IDENTITY,PURITY AND STRENGTH

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 Rasa : madhura, Tikta, Amla, lavana, katu, kasaya
 Guna : Guru, Sthula, Manda
 Virya : Usna, sheta
 Vipaka : Madhura
 Karma : Recana
 Important formulation-Aragvadhadi, kvatha, Curna,
 Therapeutic uses- vibandha, udavartta, gulma, sula, udararoga
 DOSE: 5-10g of the drug in powder form
PROPERTIES AND ACTION

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Introduction
• The United states Pharmacopoeia (USP) is an annual published
collection of quality standards.
• The first edition of the US Pharmacopoeia was published in 1864 and
was one of the first attempts to harmonize pharmaceutical standards.
UNITED STATES PHARMACOPOEIA

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Since its first publication back in 1864 the distribution of the British
Pharmacopoeia has grown throughout the world
• It is now used in over 100 countries.
• Australia and Canada are two of the countries that have adopted the
USP as their national standard.
The USP contributes to the overall control of the quality of medicinal
products by providing an authoritative statement of the quality that a
product, material or article is expected to meet any time during its
period of use.

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1. SYNONYMS: Chinese cinnamon , cassia lingnea.
Cassia bark consists of the dried bark of stems or branches of
Cinnamomum cassia Blume from which the outer tissues may have
been wholly or partly removed.
2. CHARACTERISTICS
Macroscopical Description;
Channelled or slightly curved pieces,2-3mm thick, upto 2-3cm wide,
varying considerably in length, up to 30 or 40 cm; outer surface dark
greyish-brown.
longitudinal ridges; inner surface dull cinnamon brown.
CASSIA BARK

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 Section of unscraped bark, occasional areas with small epidermal
cells, outer walls slightly thickened; cork a variable number of
alternating layers of more or less uniformly thickened, thin-walled
more markedly thickened
 lignified cortex of thin walled parenchyma, with scattered larger
cells containing mucilage ,single or small groups of uniformly
thickened sclereids
MICROSCOPICAL DESCRIPTION

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 Pericycle a continuous band, two or three cells thick, of sclereids
 Small groups of thick-walled fibres associated with outer pericycle
 Small acicular crystals of calcium oxalate in cells of medullary
rays

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 ODOUR AND TASTE
 Odour strongly resembling that of cinnamon bark, less delicate;
taste cinnamon-like, mucilaginous and astringent.
 IDENTIFICATION
 Carry out the method for thin layer chromatography using solvent
system
 Apply 60µl of each of the following solutions to the plate
(1)extract 1g of powder

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 Cassia bark by shaking with 10ml of dichloromethane for
20min.filter,evaporate the filtrate just to dryness and dissolve the
residue in 1ml of toluene; (2)0.1% cineole in toluene.
 Spray the plate with spray reagent heat at 105°c for 10-15min and
examine in daylight
 QUANTITATIVE STANDARDS
 Foreign matter - not more than 2%
 Total ash - not more than 5%
 Ash insoluble in hydrochloric acid-not more than 2%

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1. "Cassia Fistula (aburnum, Purging Fistula, Golden Shower,
Amaltas)", Ayurveda - Herbs, 4 to 40, archived from the
original on 2011-07-14, retrieved 2011-01-20
• Irwin HS, Barneby RC (1982). The American Cassiinae: A
synoptical revision of Leguminosae tribe Cassieae subtribe
Casiinae in the New World,
References

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THANK YOU

MONOGRAPHS OF HERBAL DRUGS

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MONOGRAPHS OF HERBAL DRUGS