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GUIDELINES FOR STANDARDIZATION OF
HERBAL DRUGS

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Review Article International Ayurvedic Medical Journal ISSN:2320 5091

WHO (WORLD HEALTH ORGANIZATION) GUIDELINES FOR STANDARDI-


ZATION OF HERBAL DRUGS
Nilakshi Pradhan1, Jyoti Gavali2, Nitin Waghmare3
1
HOD, Shalakyatantra Department, 2Associate Professor, Rasashastra Department,
3
HOD, Kaumarbhritya, Associate Professor;
Shalakyatantra Department, Sumatibhai Shah Ayurved Mahavidyalaya, Pune, Maharshtra, India

ABSTRACT
Herbal drugs are being used as medicines from ancient period. The increased use of herb-
al drugs, and concerns over their safety and efficacy have certainly augmented the need of stand-
ardization of these herbal drugs. WHO has set up guidelines for standardization of these drugs,
which are used as a standard by the majority of countries. The standardization includes the exter-
nal (macroscopy/microscopy) as well as internal examination/ash values, extractive values and
many other parameters to identify, authentify and study its chemical composition. Standardiza-
tion of the medicinal plants will ensure indirectly that the plants are conserved for their medici-
nal and nutritive value. Standardization confirms the safety of the medicinal plant but efficacy
has to be judged clinically or in the laboratory. There is a thin line between efficacy and the
presence of chemical compounds in the drug. The major hurdle in standardization of the batch to
batch variation in the plant compounds. Addition of finer analytical methods of the chemical
compounds may help to minimize the variation and give a better resolution of the plant drug.
Importance of toxicological examination has increased manifolds as contamination can occurs at
various stages, from collection, storage, analysis or processing to extraction of active principles.
These parameters should be recorded for years together; their database should be generated, rec-
orded and analyzed statistically to see the difference in quality and quantity of the chemical
compounds.
Keywords: Standardization, herbal drug, botanical, pharmacological, toxicological, parameters

INTRODUCTION
Medicinal plants are in use for the crude drugs by means of various parameters
purpose of treatment of different ailments like morphological, microscopical, physical,
since centuries. There has been an immense chemical and biological observations is
increase in sales of herbal OTC (Over the called standardization.1Standardisation of
counter drugs. This is growing to a billion the herbal drug begins from the collection of
dollar industry. The need for safety and effi- the herbal drug to its packaging/use as med-
cacy has also escalated since the western icine. The impediments in standardization
interest has grown. Thus the need for stand- of herbal drugs-

ardization has come into view. The process Variability in the chemical composition
of evaluation of the quality and purity of of the soil and changes in the climate in-
Nilakshi Pradhan et al: Who (World Health Organization) Guidelines For Standardization Of Herbal Drugs

fluence the range of phyto constituents individual characteristics in all respects


present in the herbal drugs.2 (Qualitative and Quantitative measure-
 Growing deforestation is leading to in- ments).Observe identifying characteristics in
crease in the number of endangered spe- few more slides to confirm the particular
cies of medicinal plants. This leads to organized crude drug. Compare these char-
addition of adulterants or substitutes to acteristics with characteristics of the same
the herbal drug. Addition of adulterants powdered crude drug mentioned in the ref-
and substitutes can change the safety and erence book.
efficacy of the drug. PHYSICOCHEMICAL PARAMATERS-
Objectives: The present article will review Chromatographic fingerprint5-Separation,
the WHO guidelines for standardization of identification, impurity detection and assay
Herbal Drugs as well as focus on the current of herbal drug in the formulation or in the
and future trends of the methods used for extract are carried out by following meth-
analysis of the herbal drug. ods: -HPTLC, HPLC/Densitometric chroma-
Thus to overcome these obstacles tography, GLC, TLC
there are many standards and parameters set Importance-The herbal drug shows variabil-
by different pharmacopeias, but guidelines ity in its chemical constituents according to
set by the WHO remain most significant. various locations/weather. To avoid any er-
Materials and Methods roneous identification chromatographic fin-
BOTANICAL PARAMATERS4- gerprint remains the assessment of choice.
Sensory evaluation-Visual macroscopy, Ash values6-The types of ash determined
Colour, Odour, Taste, Fracture are the are Total ash, Acid insoluble and water sol-
common tests conducted for identification of uble. Ash value is used to determine the
the crude drug. quality and purity of the drug and to estab-
Foreign matter-It has to be determined if lish its identity. Ash contains inorganic radi-
the foreign matter is organic (Moulds, In- cals lie phosphates, carbonates, and silicates
sects, Animal excreta etc.) or Inorganic of sodium, potassium, magnesium, calcium,
(Stone, soil etc).Foreign matter is considered etc. These are present in definite amount in a
as- particular crude drug, hence quantitative de-
 material not collected from the original termination in terms of various ash values
plant source (insects, moulds, or other helps in their standardization. Ash value is
animal contamination) used to determine foreign inorganic matter
 Parts of the organ, or organs from which present as impurity.
the drug is derived other than the parts Total Ash Value-The method of total ash is
named in the definition and description. designed to determine the amount of materi-
Methods to determine the foreign organic al that remains after ignition. Ash is classi-
matter- fied as physiological ash which is derived
 Manual method from the plant tissue itself and non-
 Lycopodium spore method physiological ash which is the residue after
Microscopy-Identification of histological ignition of extraneous matter (e.g. sand and
characters(under low and high power).Study soil).It is carried out at low temperatures
possibly because alkali chlorides, which are
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Nilakshi Pradhan et al: Who (World Health Organization) Guidelines For Standardization Of Herbal Drugs

volatile at low temperatures, may be lost. nary pressure. Many herbal drugs contain
The total ash consists of carbonates, phos- volatile oil which is used as flavoring agent.
phates, silicates and silica. For the drugs containing volatile constitu-
Acid insoluble ash- Sometimes, inorganic ents, toluene distillation method/steam dis-
variables like calcium oxalate, silica, and tillation method is used to determine the
carbonate content of the crude drug affects volatile oil contents.
‘Total cash value’. Such variables are re- PHARMACOLOGICAL PARAMA-
9
moved by treating with acid (as they are sol- TERS - Bitterness value- Medicinal plants
uble in hydrochloric acid) and acid insoluble having strong bitter taste are therapeutically
ash value is determined. Acid insoluble Ash, used as appetizing agents .The bitterness is
Water soluble ash and sulphated ash are also determined by comparing the threshold bit-
evaluated. ter concentration of an extract material with
Extractive values7- It is useful for evalua- that of quinine hydrochloride .The bitterness
tion of a crude drug. It gives an idea about value is expressed as unit’s equivalent to the
the nature of the chemical constituents pre- bitterness of a solution containing 1gm of
sent in a crude drug. Useful for estimation of quinine hydrochloride in 2000ml.
constituents extracted with the solvent used Method for determination-0.1gm of quinine
for extraction. Employed for material for hydrochloride is dissolved in 100ml drink-
which as yet no suitable chemical or biolog- ing water and the stock solution is prepared.
ical assay exists. It can be done by following Then it is diluted and tested and compared
methods: Cold maceration, hot extraction with drug.
and ethanol. Bitterness value in unit per gm = 2000×C÷
Moisture content and volatile matter8- A×B
The moisture content of the drug should be Where, A = concentration of stock solution
minimized in order to prevent decomposi- B = volume of test solution in tube with
tion of crude drug either due to chemical threshold bitter concentration C = quantity
change or microbial contamination. of quinine hydrochloride in the tube with
The moisture content is determined by heat- threshold bitter concentration
ing a drug at 105˚c in an oven to a constant Haemolytic property- Many medicinal
weight. E.g. – Aloe should have moisture plant materials, of the families Caryophyl-
content not more than 10% w/w Moisture laceae, Araliaceae, Sapindaceae, Primula-
content can be determined by following ceae, and Dioscoreaceae contain saponins.
methods- Gravimetric, Volumetric and in- The most characteristic property of saponins
strumental. is their ability to cause haemolysis; when
Gravimetric method-Loss on Drying, added to a suspension of blood, saponins
Volumetric-Azeotropic Toulene distillation produce changes in erythrocyte membranes,
method, causing haemoglobin to diffuse into the sur-
Instrumental- GC, NMR etc., rounding medium. The haemolytic activity
Volatile oil content- Volatile oils are the of plant materials, or a preparation contain-
liquid components of the plant cells, immis- ing saponins, is determined by comparison
cible with water, volatile at ordinary tem- with that of a reference material, saponin R,
perature and can be steam distilled at ordi-
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Nilakshi Pradhan et al: Who (World Health Organization) Guidelines For Standardization Of Herbal Drugs

which has a haemolytic activity of 1000 Foaming index- Many medicinal plant ma-
units per g. terials contain saponins that can cause per-
Determination- Calculate the haemolytic sistent foam when an aqueous decoction is
activity of the medicinal plant material using shaken. The foaming ability of an aqueous
the following formula: 1000 ×a/b decoction of plant materials and their ex-
Where, 1000 = the defined haemolytic ac- tracts is measured in terms of a foaming in-
tivity of saponin R in relation to ox blood, a dex. Calculate the foaming index using the
= quantity of saponin R that produces total following formula 1000/a : where a = the
haemolysis (g) b = quantity of plant material volume in ml of the decoction used for pre-
that produces total haemolysis (g) paring the dilution in the tube where foam-
Astringent property- It is determined by ing to a height of 1 cm is observed. Saponins
amount of tannins present in the drug give persistent foam when shaken with wa-
.Tannins (or tanning substances) are sub- ter. Hence, plant material/extract containing
stances capable of turning animal hides into saponins is evaluated by measuring the
leather by binding proteins to form water- foaming ability in terms of foaming index.
insoluble substances that are resistant to pro- Toxicological Parameters11-
teolytic enzymes. This process, when ap- Arsenic and heavy metals- Contamination
plied to living tissue, is known as an "astrin- of medicinal plant materials with arsenic and
gent" action and is the reason for the thera- heavy metals can be attributed to many
peutic application of tannins. Chemically, causes including environmental pollution
tannins are complex substances; usually oc- and traces of pesticides. There are different
cur as mixtures of polyphenols that are diffi- methods to identify the amount and concen-
cult to separate and crystallize. tration of heavy metals in herbal drugs.
Determination of Tannins10 -Calculate the Limit test for arsenic and Limit test for
quantity of tannins as a percentage using the cadmium and lead are few of them. The con-
following formula: where w = the weight of tents of lead and cadmium may be deter-
the plant material in grams T1=Weight of mined by inverse voltametry or by atomic
material extracted in water T2=Weight of emission spectrophotometry.
material not bound to hide powder Determination-The following maximum
T0=Weight of hide powder material soluble amounts in dried plant materials, which are
in water that bind to standard frieberg Hide based on the ADI values, are proposed: ▫
powder. [T1-(T2-T0)]×500/w lead, 10 mg/kg; ▫ cadmium, 0.3 mg/kg. Stain
Swelling Index- The swelling index is the produced on HgBr2 paper in comparison to
volume in ml taken up by the swelling of 1 g standard stain.
of plant material under specified conditions. Pesticide residues12-Examples of pesticide
Its determination is based on the addition of residues- Chlorinated hydrocarbons and re-
water or a swelling agent as specified in the lated pesticides: BHC, DDT ,Chlorinated
test procedure for each individual plant ma- phenoxyalkanoic acid herbicides: 2,4-D;
terial (either whole, cut or pulverized). It 2,4,5-T ,Organophosphorus pesticides:
gives an idea about the mucilage content of malathion, methyl parathion, parathion,
the drug; hence it is useful in the evaluation Carbamate insecticides: carbaryl (carbaril),
of crude drugs containing mucilage. Dithiocarbamate fungicides: ferbam, maneb,
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Nilakshi Pradhan et al: Who (World Health Organization) Guidelines For Standardization Of Herbal Drugs

nabam, thiram, zineb ,Inorganic pesticides: Determination- IP method: NMT 2 µg/kg of


calcium arsenate, lead arsenate aflatoxins B1& Total aflatoxins 4 µg/kg
,Miscellaneous: ethylene dibromide, eth- .USP method: NMT 5ppb of aflatoxins B1&
ylene oxide, methyl bromide, Pesticides of Total aflatoxins 20ppb.
plant origin: tobacco leaf and nicotine; pyre- Radioactive contamination-The range of ra-
thrum flower, pyrethrum extract and pyre- dionuclides that may be released into the
throids; derris root and rotenoids. Includes environment as the result of a nuclear acci-
total organic chloride and total organic dent might include long-lived and short-
phosphorous. Determination of pesticides- lived fission products, actinides, and activa-
Pesticides should not be more than 1%, an tion products. Microbial growth in herbals is
ARL (in mg of pesticide per kg of plant ma- usually avoided by irradiation. This process
terial) can be calculated on the basis of the may sterilize the plant material but the radi-
maximum acceptable daily intake of the pes- oactivity hazard should be taken into ac-
ticide for humans (ADI), as, recommended count. The nature and the intensity of radio-
by WHO, and the mean daily intake (MDI) nuclides released may differ markedly and
of the medicinal plant material. depend on the source (reactor, reprocessing
ARL=ADI×E×60/MDI×100 where ADI = plant, fuel fabrication plant, isotope produc-
maximum acceptable daily intake of pesti- tion unit, etc.). The radioactivity of the plant
cide (mg/kg of body weight); E = extraction samples should be checked accordingly to
factor, which determines the transition rate the guidelines of International Atomic Ener-
of the pesticide from the plant material into gy Agency (IAEA) in Vienna, Australia.
the dosage form; MDI = mean daily intake DISSCUSSION
of medicinal plant product. Herbal drug standardization is very im-
Microbial contamination- Contamination portant for the safety and efficacy of the
either at source or during processing is pos- drug. The safety part can be compensated by
sible. Maximum possible limits of each or- performing various analysis on the drug, but
ganism are given in various texts. WHO lim- the efficacy should not be judged only by
it for number of micro-organisms per gram the presence of the chemical compounds.
of material There is a very fine line between efficacy
Type of micro- Finished Raw ma- and presence of compounds. The need of the
organ ism product terial hour is that Clinical/Laboratory analysis
1
E.coli 10 104 should be done to establish a relation be-
Salmonella - - tween both of them. Herbal drug standardi-
3
Total aerobic 10 - zation should be done through multiple
bacteria modes as the concentration of the phyto-
Enterobacteria 103 -
chemicals varies according to climate, soil
Alfatoxins- Aflatoxins are naturally occur-
and environment. The database for the same
ringmycotoxins produced mainly by Asper-
should be maintained throughout the year
gillusflavus and Aspergillusparasiticus. The
and the data should be analyzed statistically
presence of aflatoxins can be determined by
for proper understanding of the medicinal
chromatographic methods using standard
plant. Newer aids of research should be used
aflatoxins B1, B2, G1, G2 mixtures.
to identify minute variations. Finer analyti-
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Nilakshi Pradhan et al: Who (World Health Organization) Guidelines For Standardization Of Herbal Drugs

cal methods are now available which can be 4. Kokate C.K., Gokhale, S.B. 2001. Prac-
incorporated to analyze the herbal drugs. tical Pharmacognosy. 2nd ed. NiraliPra-
Gel electrophoresis of isolated and purified kashan, Pune, p. 14-19. 2
DNA samples is done to identify the herbal 5. Yvan Vander Heyden, Sept 1
drug as it cannot vary with factors like cli- 2008,Extracting Information fromChro-
mate, etc. DNA fingerprinting can be made matographic HerbalFingerprints,LCGC
the choice of analysis for a perfect assess- Europe,Volume 21, Issue 9
ment of authentification. Flow cytometry 6. Quality control of herbal drugs. 4th ed.
can also be applied for herbal drug identifi- Business Horizons, New Delhi, P. 184-
cation, drug discovery and development. 219.
CONCLUSION 7. Ansari S.H. 2006. Essentials of Pharma-
The WHO guidelines are followed cognosy. 1st ed. Birla Publications, New
all over the world but the need of the hour is Delhi, p. 581- 596.
to update these principles with application of 8. http://www.ncbi.nlm.nih.gov/pubmed/18
newer methods of analysis. The herbal drug 396809.
assessment in Ayurveda is about the whole 9. Anonymous, 2010. Indian Pharmacopoe-
drug rather than concentrating on the active ia. Vol.-3, Government of India, Minis-
principles or phytoconstituents, thus finer try of Health and Family Welfare, New
methods of standardization should be devel- Delhi p. 2467-2472
oped. As Ayurvedic drugs are also included 10. Mukherjee P K & Peter J Houghton.
in the Drugs and Cosmetics Act, 1940 the 2009. Evaluation of Herbal Medicinal
drugs have to be safe and effective at the Products Perspectives on quality, safety
same time. This brings about the need for and efficacy. Pharmaceutical Press Lon-
finer standardization of herbal drugs. We don P, 19-23
can certainly avoid the external contamina- 11. Iqbal Ahmad, FarrukhAqil, and Mo-
tion due to the pesticides by organic farm- hammad Owais. Modern Phytomedicine,
ing, heavy metal contamination by perform- Turning Medicinal Plants into Drugs
ing soil analysis and other tests, radioactive WILEY-VCH Verlag GmbH & Co.
contamination is not very common in India KGaA,Weinheim fGermany 2006 p.26-
but it can be prevented by using healthier 53
ways of prevention. 12. http://testinglaboratoryindia.com/ha-
REFERENCES analytical-specifications.htm
1. K R Khandelwal, 2013, PracticalPhar- CORRESPONDING AUTHOR
macognosy, 2nded, Nirali Prakashan, Dr Nilakshi Pradhan
Pune,23.1-23.4. Email: sumedhayk@yahoo.com
2. SS Agarwal,M Paridhavi,2007. Herbal
Drug Technology,FirstEd,Universities
Source of support: Nil
Press(India) Pvt. Ltd,Hybd.Pg629-630.
Conflict of interest: None Declared
3. WHO Quality Control Methods for Me-
dicinal Plant Materials, World Health
Organization, Geneva, 1998

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