In this slide contains Monographs of Herbal Drugs Study in British Herbal Pharmacopoeia and American Herbal Pharmacopoeia. Presented by: M.SUDHEESHNA (Department of pharmaceutical analysis ).RIPER, anantapur

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
Monographs of Herbal Drugs Study in
British Herbal Pharmacopoeia &
American Herbal Pharmacopoeia
A Seminar as a part of curricular requirement
for M.Pharm I year II Semester
Presented by
M.SUDHEESHNA
(Reg.no:20L81S0713)
Pharmaceutical Analysis

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
Pharmacopoeia
Contents of Pharmacopoeia
Monograph
Purpose of Monograph
Types of Monograph
Importance of Contents of Monograph
British Pharmacopoeia – 2008, 2013, 2014
Monograph of Aloe
American Pharmacopoeia
Monograph of Valerian Root
Comparision between BHPAnd AHP
References
Contents:

3. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
• The word derives from the ancient Greek word pharmakon - drug &
poeia - to make.
• It is a legally binding, collection, prepared by a national or regional
authority & contains list of medicinal substances, crude drug &
formulas for making preparation from them.
• It comprises list of pharmaceutical substances, formulae along with
their description and standards.
• It is a legal and official book issued by recognized authorities usually
appointed by Government of each country.
Pharmacopoeia:

4. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
• List of drug and other related substances
• Sources
• Description
• Tests
• Formulas for preparation
• Uses
• Doses
• Storage conditions
Contents of pharmacopoeia:

5. RIPER
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NAAC &
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
• A detailed written study of a single specialized subject or an aspect
of it.
• Herbal monographs in national pharmacopoeias and other
authorative documents play an important role in the authentication
of herbal materials.
• In this context a monograph is a document that defines a botanical
drug and provides information that allows for its proper
identification.
• The herbal monographs give a basic description of the herb, and list
of its chemical constituents, actions, clinical uses and recommended
dosage etc.
Monograph:

6. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6
• Provide scientific information on the safety, efficacy, and quality
control / quality assurance of widely used medicinal plant.
• Provide models to assist Member States in developing their own
monographs or formularies for these or other herbal medicines.
• The goal of the monograph project is to protect those who have an
interest in traditional medicines (patient, prescriber, pharmacist,
manufacturer, health authority, medicines regulatory body) against
medicine of poor quality.
The Purpose of the Monographs:

7. RIPER
AUTONOMOUS
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
1. Standard Monograph:
• Botanical features
• Distribution
• Identity tests
• Purity requirements
• Chemical assay
• Chemical constituents
Example: USP Standards monograph
Types of monograph:

8. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
2. Therapeutic monograph:
• Definition Of The Plant Drug
• Clinical Applications
• Pharmacology
• Contraindications
• Warnings
• Precautions
• Potential Adverse Reactions
• Posology ( Form of Administration, Duration of Use)
Examples: ESCOP (The European Scientific Cooperative On
Phytotherapy) Monographs.

9. RIPER
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NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9
3. Combined monograph:
• Standard monograph + Therapeutic monograph = Combined
monograph.
Examples: 1. WHO (World Health organization) monographs
2.AHP (American Herbal Pharmacopeia) monographs

10. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
Definition :
• Definition section provides the Latin binomial pharmacopoeial name,
the most important criteria in quality assurance.
Synonyms and Vernacular Names :
• Those names used by local consumers.
• The vernacular names listed are a selection of names from individual
countries worldwide, in particular from areas where the medicinal
plant is in common use.
Description :
• A detailed botanical description is intended for quality assurance at
the stages of production and collection.
 Macroscopy
 Microscopy
Importance of Content Of the Monographs:

11. RIPER
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NAAC &
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
Geographical Distribution :
• Geographical distribution included here to provide additional
quality assurance information.
Major Chemical Constituents:
• Each medicinal plant & the specific plant part used (the drug) contain
active or major chemical constituents with a characteristic profile that
can be used for chemical quality control & quality assurance.
Identity, Purity and Strength:
• Under the heading “Identification” tests are provided as an aid to
identification and are described in their respective monographs.
• It includes Foreign Matter & Quantitative tests.

12. RIPER
AUTONOMOUS
NAAC &
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
Quantitative Tests :
• Total ash , Acid-insoluble ash
• Water-soluble ash
• Alcohol-soluble extractive
• Water- soluble extractive
• Ether-soluble extractive
• Moisture content
• Volatile oil content
• Bitterness valves
Chromatographic and Spectroscopic Evaluation:
• TLC, HPTLC, HPLC methods will provide qualitative &
quantitative information about the main active constituents present in
the crude drug.

13. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13
Toxicology:
• Important for the poisonous plant.
• It includes the study of adverse effect of drugs as the same
substance can be a drug or a poison depending on the dose.
Safety :
• If no specific toxicity is reported, it is considered to be safe in the
dose traditionally used.
Adverse Drug Reaction :
• It give the information about any change which is suspected to be
due to drug, occurs at doses normally used in man and indicates
caution in the future use of the same drug.
• ADR may develop promptly or after prolonged medication or even
after stop age of the drug.

14. RIPER
AUTONOMOUS
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
• First edition of BP was published in 1864.
• It consist of two sections:
Part I :- Materia Medica
Part II :- Preparation & compounds.
• Second edition of BP was published in 1867.
• Fourth edition of BP was published in 1898.
• Fifth edition of BP was published in 1914.
• Eighth edition of BP was published in 1953.
• In this edition titles of drugs & preparations were in English instead
of Latin and metric system.
British Pharmacopoeia:

15. RIPER
AUTONOMOUS
NAAC &
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
• BP 2008 contains approximately 3100 monographs for
substances, preparations and articles used in practice.
• It has been made effective from 1st January 2008.
• BP 2007-2009 were given in Six Volumes i.e. Volume I to Volume VI.
• Volume I & II - medicinal substances.
• Volume III - formulated preparations, blood related products,
immunological products, radiopharmaceutical preparations, surgical
materials & homoeopathic preparations.
• Volume IV - supplementary chapters, IR spectra etc.
• Volume V - veterinary.
• Volume VI - CD ROM version.
British Pharmacopoeia - 2008

16. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
• It has been published annually.
• In BP 2007 monographs has been introduced for material
specifically used in preparation of Traditional Chinese medicines.
British pharmacopoeia - 2013
The BP 2013 package includes:
• 6 volume printed edition including the BP (Veterinary) 2013
New for 2013:
• 41 new BP monographs
• 40 new European Pharmacopoeia monographs
• 619 amended monographs
• 6 new and 1 amended Infrared Reference Spectra

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17
• The 2014 edition includes almost 3500 monographs which
are legally enforced by the Human Medicines Regulations 2012.
The BP 2014 package comprises :
• 5 volumes of the British Pharmacopoeia 2014.
• 1 volume of the British Pharmacopoeia (Veterinary) 2014, along with
a fully searchable CD-ROM.
New for 2014:
• 2014 Legally effective from 1 January 2014.
• 40 new BP monographs.
• 272 amended monographs.
• 3 new Supplementary Chapters.
• 4 new BP (Vet) monographs, 1 new BP (Vet) Supplementary Chapter
British Pharmacopoeia - 2014

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
Botanical Nomenclature : Aloe Barbadensis
Family : Liliaceae
Chemical Constituents:
Major constituents includes :
• Glycosides - Anthracene derivatives - Hydroxy anthraquinone
derivatives, barbaloin, a mixture of aloin A & B, the
diastereoisomeric 10-C glucosides of aloe-emodin anthrone and 7-
hydroxyaloin isomers.
Minor constituents includes:
• Aloe-emodin, chrysophanol, chromone derivatives - aloeresin B
(upto 30%) with its p - coumaryl derivatives aloeresins A & C and the
aglycone aloesone.
Monograph of Aloe :

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 19
Macroscopic Identification:
• Leaves : It has thick leaves that grow in a rosette shape.
• The parenchyma of leaves contain large quantities of pulp.
• The fleshy leaves with serrated edges that arise from a central base
and grow to nearly 30-50 cm long have 10 cm width at the base.
Microscopic Identification:
Leaves are composed of three layers:
• An inner clear gel : 99% water and rest is made of glucomannans,
amino acids, lipids, sterols and vitamins.
• The middle layer of latex : bitter yellow sap and contains
anthraquinone and glycosides.
• The outer thick layer : 15–20 cells called as rind which has
protective function and synthesizes carbohydrates and proteins.

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20
Identity Tests:
• Mix 0.5g with 50ml water, boil until nearly dissolved, cool ,
add 0.5gm of Kieselguhr and filter.
• Heat 5ml of the filtrate with 0.2g of borax until dissolved, add a few
drops of this solution to a test tube nearly filled with water, a green
fluorescence is produced.
Assay / Analytical Methods (From Extracts):
1.Ascorbic acid estimation by HPLC method:
HPLC System : Shimatzu 2010 CHT
HPLC with UV detector : 254 nm
Column : C-18
Mobile phase : 5% Methanol in 0.01 M KH2PO4
Flow rate : 1ml/min
Retention time : 2.60min
Standard : Ascorbic acid

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21
2) Aloin estimations by Gravimetric method.
3) Total phenolics by spectrophometric method

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22
Qualitative standards:
• Total Ash : Not More Than 2%
• Water Soluble Extracts : Not More Than 50%
• Alcohol Insoluble Extracts : Not More Than10%
• Moisture : Not More Than12%
• Pesticide Residue : Aldrin and Dieldrin is not more than 0.05mg/kg
• Heavy Metals :Lead and Cadmium are not more than 10&0.3mg/kg
• Microbiological :
Aerobic Bacteria : Not More Than 107 /gm
Fungi : Not More Than 105 / gm
Escherichia Coli : Not More Than 102 / gm

23. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 23
Uses:
• Immunomodulatory
• Wound healing
• Anticancer
• Radioprotective efficacy
• Angiogenic
• Antiviral
• Analgesic
• Anti-inflammatory
• Hypotensive
• Prevents Aging of Skin

24. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24
• The primary goal of the AHP is to produce authoritative herbal
monographs containing accurate, critically reviewed information on
botanicals which can provide guidance in the appropriate use of
herbal therapeutics.
• The AHP began developing qualitative and therapeutic monographs
in 1994, and intends to produce 300 monographs on botanicals,
including many of the ayurvedic, Chinese and western herbs.
• The AHP monographs are combined monographs; they include much
of the standard definition and analytical information found in
conventional pharmacopoeial monographs on standards, therapeutic
and clinical information.
American Herbal Pharmacopoeia:

25. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25
Botanical Nomenclature : Valeriana officinalis
Botanical Family : Valerianaceae
Definition : Valerian consists of the fragments or whole fresh or dried
rhizomes, roots, and stolons of Valeriana officinalis.
Identification:
Botanical Identification:
Stem : Solitary, hollow, 15-150 cm.
Leaf : Basal and cauline, opposite, oddly once pinnately lobed, lobes
11- 21 lanceolate, entire or dentate, basal leaves petiolate, cauline
leaves subsessile to clasping.
Inflorescence: Compound cyme, terminal or axillary, many pale pink
to white, strongly scented flowers.
Monograph of valerian root:

26. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 26
Macroscopic Identification :
 shape : Rhizome is up to 50 mm long and up to 30 mm in
diameter, obconical to cylindrical, with an elongated or compressed
base.
Colour: It has a yellowish-brown to dark brown exterior with a
circular stem and leaf scars.
 Aroma: A very faint characteristic,valeric acid like aroma
 Taste: Mildly sweet and camphoraceous with a slightly bitter and
spicy aftertaste
Microscopic Identification:
• Starch grains are numerous, up to 20 µm in diameter, mainly 2-4
compound with cleft or radiate hilum, packed into parenchymatous
cells of cortex

27. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 27
• Sclereids from the rhizome are small with thick walls,
narrow branched lumen, and numerous pits.
• Piliferous layer shows cicatrices or occasionally attached
unicellular root hairs and associated hypodermis of elongated cells.
Constituents:
• These include the essential oil and its sesquiterpenoids (valerenic
acid), epoxy iridoid esters (valepotriates) and their decomposition
products such as baldrinal and homobaldrinal, amino acids (arginine,
GABA, glutamine, tyrosine), and alkaloids.
• Valerian also possesses small amounts of phenolic acids and
flavonoids, valerosidatum, chlorogenic acid, caffeic acid, choline, β-
sitosterol, fatty acids, and various minerals

28. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 28
Analytical methods:
1. Assay of volatile oils
2. TLC,HPTLC
3. HPLC
Column : C-18, 5 µm, 4.6 x 250 mm
Mobile Phase : Methanol:0.5% phosphoric acid (80:20).
Flow Rate : 1.5 mL/minute.
Detection : 225 nm.
Injection Volume : 20 µL.
Run Time : 15 minutes.
Elution Order : Hydroxy valerenic acid, acetoxy valerenic acid,
valerenic acid, valerenal

29. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 29
Calculation :
• Calculate the percentage of valerenic acid alone or total
valerenic acids using the following formula.
100 V (C/W)(ru /rs)
• V = volume in mL of the sample preparation.
• C = concentration in mg/ mL of the standard solution.
• W = weight in mg of valerian used to prepare the sample solution
• ru and rs = peak responses obtained from the sample solution and the
standard solution.

30. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 30
Qualitative Standards:
• Foreign Organic Matter : Not more than 5% stem bases,
Not more than 2% other foreign matter
• Total Ash : Not more than 12%
• Acid Insoluble Ash : Not more than 5%
• Loss of Moisture on Drying : Not more than 12%
• Extractable Matter : Not less than 20%.
The residue should weigh not less than 0.1 g
• Microbial Contamination : Negative for Salmonella species,
Escherichia coli, and Staphylococcus aureus

31. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 31
• Insomnia
• Anxiety
• Depression
• Menstrual disorders
• Epilepsy
• Attention-deficit Hyperactivity Disorder(adhd)
• Chronic Fatigue Syndrome
• Muscle and Joint Pain
• Mild Tremors
Uses:

32. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 32
Comparison Between BHP and AHP

33. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 33
1. Balderer G, Borbély A, psychopharmacology, Effect of valerian on
Human Sleep – 1985, 87:406-9.
2. Blumenthal M, Busse W, Hall T, Goldberg A, Grünwald J, The
Complete German Commission E Monographs Therapeutic Guide to
Herbal Medicines- 1985, page : 685.
3. Azaroual L, Liazid A, Barbero GF, Improved chromatographic
methods for determination of bioactive compounds from Aloe vera
leaves, ISRN Chromatography- 2012.
4. Boudreau MD & Beland FA An evaluation of the biological and
toxicological properties of Aloe barbadensis -2006
References:

34. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 34