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8/3/2019 Standardization of Herbal Drugs Edited
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Standardizatio
n of herbal
drugsPandure Dinesh R.Department of Pharmacology
and Toxicology
Mumbai Veterinary College
Pandure Dinesh R.
M.V.Sc.(Sr.)
Department of Pharmacology &
Toxicology
Mumbai Veterinary College,Parel
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Introduction
What is standardization?
WHO Guidelines
Different Tests Regulatory Bodies
Conclusion
References
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Ayurveda
Originated in India
Ayurveda
Ayus (life)
Veda (knowledge or science)
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AYURVEDA
PAST
Raw material collected by
vaidya
Formulated the drug
Dispensed the drug and
supervised the use of drugs
PRESENT
Raw material supplied by
suppliers
Number of manufacturers
Dispensed by hundreds of
practioners
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Importance of HerbalsLimitations of Allopathy :
1.Degenerative disorders
2.Re-emerging resistant infections
Herbal drug avenues:
Primary health care
Diabetes
Dyslipidemias
Liver diseases
Anti-aging
Osteoporosis
Immunostimulants
Anti-cancer
Drugs affecting male
libido
Chronic arthritis
Neurological like
alzheimer,
Pushpangadan(2003)
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World Health Organization
Identified medicinal plants: 21,000 in 91 countries
(Penso, 1983)
Investigated:
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Medi
cina
lPlan
tsare
used
byTr
ibalCom
munities(oral)
8000 species
Ayurveda900 sp.
Unani700 sp.
Siddha600 sp.
Amchi250 sp.
INDIAN
SYS
TEMSOFMEDICINE
Modern30 sp.
Indias strength inHerbal Technology
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What is standardization..?
Definition of the content of a constituent or a group of
substances with known therapeutic activity
OR
Ensuring that every packet of medicine has correctingredients in the correct amount and will induce the
intended therapeutic effect.
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Why we follow this?
Quality control
Safety for Human consumption
World market
WHOs, (GMP) - ISO 9000Environmental safety- ISO 14000
(Ecological damage)
Joy et al.(1998)
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LEGAL REQUIREMENTS
USA : Proof of quality, safety and efficacy
Europe:Harmonization by use of the EuropeanScientific Cooperative on
Phytotherapy (ESCOP), since 1989
India : GMP norms should befollowed
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WHO GUIDELINES
WHO GuidelinesBotanical: -
Physicochemical TLC:-
Pharmacological: -
Toxicological: -
Microbial contamination: -
Panchawat et al.(2009)
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QUALITY EVALUATION OFQUALITY EVALUATION OF
HERBAL DRUGSHERBAL DRUGS
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Authentication
(Schedule T of the Drugs and Cosmetics Act ,1940)
Institute for Authentication Central Council For Research In Ayurvedic Medicine
Central Council For Research In Unani Medicine(CCRUM)
Pharmacopeic Data
Parameters Parts of plants - leaf, flower, root, stolen
Regional status
Family
Biological source
Chemical constituents
Gautam et al.(2010)
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Macroscopy parameter Microscopy parameter
Colour- Greenish -brown Epidermis-strongly
thickened, pitted, lignified
Odour-none Collapsed cells- present
Taste-intensely bitter Endosperm- unlignified,
plasmodesma, aleuronegraines
Size-10-30mm in diameter
4-6mm in thickness
Calcium oxalate crystals-
present
BOTANICALBOTANICAL EVALUATIONEVALUATIONExample :Nux vomica
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Parts of the Plant: Qualities
Roots: Alkaloid rich, often toxic, often
medicinal
Leaves: Nutrient rich
Flowers: Some nutrients, energetically
powerful
Seeds: Nutrient dense, often toxic, toxins
often medicinal
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Under ground parts
Freed from soil Insect attacked plantparts rejected
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Environmental variationEnergy moves with the seasonRoots in spring and fall when plant is storing constituents
Ex...
Datura (Alkaloid): lower in cloudy/rainy weather
Volatile oils: warmer weather
Annual Biennials Perennials
Leaves Roots Seeds
Flower Flowers
Seeds
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Physical evaluationVISCOSITY
Viscosity of a liquid is constant at agiven temperature & is an index of
its composition.
MELTING POINT
Pure phytochemical: Constant MP
Their purity can be checked
E.g. Colophony- 75-80c
Cocoa butter- 30-33c
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Contd.
SOLUBILTY :
Adulteration
E.g. Pure Asafoetida -soluble in carbon disulphide
MOISTURE CONTENT
Decomposition (chemical change or microbial contamination)
Moisture:105c in an oven
E.g. Aloe 10% (w/w)
VOLATILE MATTER
Toulene distillation
aromatic drugs
Drugs Volatile oil content
(%w/w)
Lemon Not less than 2.5
Lemon Not less than 2.5
clove Not less than 15
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Contd
OPTICAL ROTATION
Property of rotating the plane of polarized light(optical rotation) Normally, the optical rotation is determined at 25c using sodium
lamp as the source of light.
E.g. castor oil - 3.5to +6
REFRACTIVE INDEX
When a ray of light passes from one medium to another of
different density, then the ratio of velocity of light in vaccum to
its velocity in substance is termed as refractive index of secondmedium.
E.g.
Drugs Refractive index
Arachis oil 1.4678-1.470
Caraway oil 1.4838-1-4858
Castor oil 1.4758-1.527
Clove oil 1.527-1.535
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Contd
ASH VALUES AND EXTRACTIVES
The residue remaining after incineration is the ashcontent of drug
Total ash method
Acid insoluble ash
Water soluble ash
BITTERNESS VALUE
Appetizing agents
quinine hydrochloride
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WATER AND VOLATILE MATTER:
Azeotropic method is used to directly measure the water present in
a material
Loss on drying
In order to measure volatile matter, plant is diluted with water and
distillate is collected in a graduated tube. The aqueous portion
separates and returns to distillation flask. A solvent of low mass
density with a suitable boiling point may be added to measuring
tube to easily separate the volatile oil.
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Chemical evaluation
Qualitative chemical evaluation
Tests Reagents used Color formedAlkaloidsMayers tests Potassium mercuric iodide
solutionCream precipitate
Wagners tests Iodine potassium solution Brown precipitate
Hagers tests Saturated solution of picric acid Yellow colour Amino acids
Millons tests Millon reagents White precipitate
Ninhydrine tests Ninhydrin solution Violet colour
CarbohydratesMolischs tests Alcoholic a-naphthol+sulphuric
acidPurple to violet
colour Rings
Barfoeds tests Barfoed reagents Red colour
Selivanoffs tests Selivanoffs reagents Rose colour(keton)
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Quantitative chemical evaluation
Chemotaxonomy:
Classification of plants and organisms by their
chemical constituents
Techniques: Phytochemical Screening
Thin layer chromatography (TLC)
High performance liquid chromatography (HPLC)
Gas chromatography (GC)
Ultraviolet/Visible spectroscopy (UV/VIS)
Mass spectrometry (MS)
Combination of GC and MS (GC/MS)
Over-pressured layer chromatography (OPLC)
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DNA fingerprinting
Identification of medicinal plants
Identification of germplasms of important or
endangered plants for future cultivation or conservation(Vasudevan 2004)
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Biological evaluation
Bacterial and mold contents in a plant are influenced bythe environment
Harvesting and production practicesPermissible Limit As per WHO
MMiiccrrobesobes Forfurther
processing
forTopical use
For
intravenous
E. coli 104
Cfu/g
102
Cfu/g
101
Cfu/g
Enterobacteria - 104
Cfu/g
10+
Cfu/g
Salmonella - - -
Total aerobic
bacteria
107
Cfu/g
105
Cfu/g
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REGULATORY BODIES
(AN ORGANISATIONAL SET UP)
CENTRALLEVEL
Central Department under
Ministry ofHealth & Family
Welfare. Govt ofIndia
Central Research Councils.
Central Regulatory Bodies.
National Institutes.
National Medicinal Plant
Board. Central Pharmacopoeia
Laboratories
Manufacturing Unit
Hospitals & dispensaries
STATE LEVEL
AYUSHDepartment or
Ministry.
State Directorates State Boards/Councils for
registration of practitioners.
State Licensing/Drug Control
Authorities.
State colleges/institutions. State Pharmacies
State Drug Testing
Laboratories.
State Medicinal Plant Boards
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TOXICOLOGICAL
STANDARDIZATION
Determination of
Pesticides.
Heavy metalsRadioactive contamination
Aflatoxins.
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Determination of pesticides.
Qualitative : Partition and/or adsorption,
Quantitative : GC, MS, or GC/MS.
S.No
.
Name of
Pesticides/insecticides
Limit as per
FDA/ EP
1. Quinolphos 0.01 ppm
2. DDE 1.00 ppm
3. Alderin 0.05 ppm
4. Dieldrin 0.05 ppm
5. DDT 1.00 ppm
6. DDD 1.00 ppm
7. HCH (Hexa
chlorocyclohexane)
0.30 ppm
8. Malathion 0.10 ppm
9. Parathion 0.30 ppm
MRL level ,WHO
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Determination of arsenic and heavy
metalsTrace amounts dangerous
Amount is estimated by matching the depth of colour with of
standard stain
MRL level ,WHO
Arsenic 10.0 ppm
Cadmium 0.30 ppm
Mercury 1.00 ppm
Lead 10.0 ppm
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Radioactive Contamination
Source:
Radionuclides
Nuclear accident
(Eg..Nuclear accident in Chernobyl)
Effect depends on:
Level of contamination
Quantity of the contaminant consumed
Quantity of herbal medicine normally consumed by an individual
Shrikumer et. al.(2006)
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Fungus(Aflatoxins)
Dangerous in minute amounts
Faulty storage Eg.-Nuts,Cereals
TLC : for confirmation(After clean-up )
Toxin produce cancer in human beings Stored nuts and cereals are contaminated by the fungus
They should therefore be determined after using a suitable clean
up procedure.
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PHARMACOPOEIA
FORMULARIES
Ayurvedic Pharmacopoeia: 418
monographs
Ayurvedic Formulary: 636
formulations.
Pharmacopoeial laboratories of
Indian medicines(PLIM) for
SOPs and pharmacopoeial
standards.
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Conclusion
There have been various guidelines issued on thestandards of the herbal drugs by the concerned
governing bodies like CDSCO, US-FDA etc.
While developing an herbal drug formulation, producer
must have all the related knowledge.
There are still many drugs which are not included in
these official guidelines and books.
Stringent regulation have been made to determine theconformity of these new chemicals
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References
Archana Gautam, Shiv Jee Kashyap, Pramod Kumar Sharma,Vipin and Kumar Garg(2010) Identification, evaluation and
standardization of herbal drugs,DerPharmacia Lettre, 2(6): 302-
315
P. P. Joy, j. Thomas samuel, mathew baby, p. Skaria (1998)Medicinal plants Kerala Agricultural University
WHO (2002) Traditional medicine strategy World health
organization, Geneva.
S Shrikumer; U Maheshwari; A Sughanti; TK Ravi(2006) WHOguidelines for herbal drugs standardization.
Sunita Panchawat, Kamal Singh Rathore,.Dr.S.S.Sisodia, Dr.
R.K.Nema(2009) Standardisation And Evaluation Of Herbal
Drug Formulations,Articlebase
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P mukharji. Quality control methods of herbal drugs, 1st ed.,
Business horizon pharmaceutical, Kolkata, 2001; 578-80.
CK Kokate; APPurohit; SB(2006) Gokhale. Pharmacogognosy ,35th ed., Nirali Prakashan, Pune, 98-114.
M Ali (2009)Pharmacognosy and phytochemistry 3rd ed., CBS
publishers & distributors, Delhi, 181-182.
P
MP
atel; NMP
atel; RK Goyal. The Pharma Review, 2006, (22),113.
PS Sagar Bhanu; R Zafar; RPanwar. The Indian Pharmacist,
2005, 4(35), 2005, 19-22.
Yoganarashimhan SN(1996) Medicinal Plants of India, Karnal for
interline Publishing Pvt Ltd,Bangalore. 4.
PM Patel; NM Patel; RK Goyal(2006) The Indian Pharmacist,
5(45), 26-30.
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Vasudevan H. 2004. DNA fingerprinting in the standardization of herbs andnutraceuticals. The Science Creative Quarterly.
(http://www.scq.ubc.ca/?p=286)
P. Pushpangadan (2003)Quality control & Standardization of herbal drugs,
National Botanical Research Institute,Lukhnow
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Thank you