Standardization of Herbal Drugs Edited

8/3/2019 Standardization of Herbal Drugs Edited

1/39

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


2/39

Introduction

What is standardization?

WHO Guidelines

Different Tests Regulatory Bodies

Conclusion

References


3/39

Ayurveda

Originated in India

Ayurveda

Ayus (life)

Veda (knowledge or science)


4/39

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


5/39

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)


6/39

World Health Organization

Identified medicinal plants: 21,000 in 91 countries

(Penso, 1983)

Investigated:


7/39

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


8/39

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.


9/39

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)


10/39

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


11/39

WHO GUIDELINES

WHO GuidelinesBotanical: -

Physicochemical TLC:-

Pharmacological: -

Toxicological: -

Microbial contamination: -

Panchawat et al.(2009)


12/39

QUALITY EVALUATION OFQUALITY EVALUATION OF

HERBAL DRUGSHERBAL DRUGS


13/39

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)


14/39


15/39

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


16/39

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


17/39

Under ground parts

Freed from soil Insect attacked plantparts rejected


18/39

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


19/39

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


20/39

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


21/39

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


22/39

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


23/39

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.


24/39

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)


25/39

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)


26/39

DNA fingerprinting

Identification of medicinal plants

Identification of germplasms of important or

endangered plants for future cultivation or conservation(Vasudevan 2004)


27/39

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


28/39

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


29/39

TOXICOLOGICAL

STANDARDIZATION

Determination of

Pesticides.

Heavy metalsRadioactive contamination

Aflatoxins.


30/39

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


31/39

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


32/39

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)


33/39

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.


34/39

PHARMACOPOEIA

FORMULARIES

Ayurvedic Pharmacopoeia: 418

monographs

Ayurvedic Formulary: 636

formulations.

Pharmacopoeial laboratories of

Indian medicines(PLIM) for

SOPs and pharmacopoeial

standards.


35/39

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


36/39

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


37/39

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.


38/39

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


39/39

Thank you

Standardization of Herbal Drugs Edited

Documents

Transcript of Standardization of Herbal Drugs Edited