Research J. Pharm. and Tech. 1(4): Oct.-Dec.

2008,
,

ISSN 0974-3618 www.rjptonline.org

REVIEW ARTICLE

Standardization Strategies for Herbal Drugs-An Overview

Neeli Rose Ekka*. Kamta Prasad Namdeo and Pradeep Kumar Samal
SLT Institute of Pharmaceutical Sciences, Guru Ghasidas University ,Bilaspur (CG.)
*Corresponding Author E-mail: nreekkarose@ yahoo.co.in

ABSTRACT:
Eighty of world population is dependent on herbal drugs and to enter into the global market it is vital to maintain its quality.
The quality of herbal drugs is the sum of all factors which contribute directly or indirectly to the safety, effectiveness and
acceptability of the product .Standardization of drugs means confirmation of its identity and determination of its quality and
purity. Initially the crude drugs were identified by comparison only with the standard description available. At present due to
advancement in the chemical knowledge of crude drugs various methods like botanical, chemical, spectroscopic and
biological methods are used for estimating active constituents present in the crude drugs in addition to its physical constants.

KEY WORDS: Standardization, quality, purity, herbal products.

INTRODUCTION: PHARMACOPOEIAL STANDARDS3-7 :

A system to ensure that every packet of medicine that is
being sold has the correct substances in the correct
amount and will induce its therapeutic effect this is
known as standardization.
It is very important that a system of standardization is
established for every plant medicine in the market
because the scope for variation in different batches of
medicine is enormous. Plant material may vary in its
phytochemical content and therefore in its therapeutic
effect according to different places of collection, with
different times in a year for collection, with collection at
the same time and places but in different years and with
different environmental factors surrounding the
cultivation of a particular medicinal plant. Adding to this
variability is the fact that in herbal medicine several
plants may be used together in the same preparation. This
means that there should be a quality control test for the
entire preparation to ensure quality of the product.
World Health Organization (WHO) encourages,
recommends and promotes traditional /herbal remedies in
national health care programmes because these drugs are
easily available at low cost, safe and people have faith in
them. The WHO assembly in number of resolutions has
emphasized the need to ensure quality control of
medicinal plant products by using modern techniques and
applying suitable standards.1-2
Received on 01.09.2008 Modified on 10.11.2008
Accepted on 12.12.2008 © RJPT All right reserved
Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008; Page 310-312
The authenticity, quality and purity of herbal drugs are
established by reference given in pharmacopoeia. The
pharmacopoeia prescribes (numerical value) like
structural, analytical, physical standards for the drugs.
The important standards mentioned in pharmacopoeia are
shown in figure 1.
A critical examination and identification of crude drugs is
required in manufacturing of herbal formulation because
of great diversity and variability in their chemical
characters. To overcome this problem all the
pharmacopoeias have laid down certain standards.
Specific tests for certain plant materials are given below.
Volatile oil content Hemolytic activity Foaming index Bitter
value Tannin content. Fat content Acid valueSaponification
value Iodine value Assay forAluminium/ Arsenic
/Borate/Calcium. Camphor/ Chloride/Copper/ Gold/Iron.
Lead/Magnesium/ Mercury/Phosphate. Potassium/Silica/
Silver/Sodium.Sulpher/Sulphate/Tin.
PHYTOCHEMICAL ASSAY8-19 :
Most of the drugs have definite specific chemical
constituents to which their biological or pharmacological
activity is attributed. Qualitative and quantitative
characterization of the active ingredient should be assayed
using biomarkers. Defining of the biomarker has to be
very specific and a lot of insight has to go into it before
declaring any distinct molecule. Additionally the mixture
should be analyzed to develop finger print profile. A
general protocol followed for chemical assay for herbal
drugs is shown in figure 2.

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Figure 1. Standardization parameters for plant drugs

Microscopic Authenticity, Macrosc

examination quality,
purity
Total ash Extractive
value value

Pharmacopoeial standards
Radioact Foreign
matter

Moisture
Microbial
content
count

Heavy
metals
contents Pesticide
Specific Density residue
Refractive gravity
Viscosity
index
Loss on
drying
Melting
point

Isolation of compounds Column chromatography PROCESS CONTROL OF HERBAL DRUGS:

Partition chromatography Thin layer chromatography Gas Drugs are manufactured from different raw materials by
liquid chromatography High performance liquid using different methods or process. Some impurities are
chromatography High performance thin layer incorporated into the material during the manufacturing
chromatography. process. Multiple-step procedure which produces
Figure 2. Phyto chemical evaluation of herbal drugs intermediate compounds. In- process control provides
information on general characters, identification test and
Finger Solvent other applicable tests such as inorganic and heavy metal
printing of Estimation of active extraction impurity, microbial limit, and pesticide reside besides,
plant drugs principles
safety, assay and stability. In addition to the foregoing
portions of the initial final and in process samples are
used for collecting average run samples for the quality
Isolation of Isolation of control laboratory to perform final batch analysis and
chemical Phytochemistry
compounds by release. Process control is shown in figure 3.
markers for chromatography
fixing
pharmacopo CONTROL OF FINISHED PRODUCT:
eial Large scale isolation of Specification for finished product should be defined. Final
standards of active studies testing of finished product is made in the quality control
single and laboratories. These tests are designed to determine
compound compliance with specifications. Thus the testing of the
Structural
formulations finished product for compliance with predetermined
elucidation by
IR, MS, UV standard prior to release of the product for packaging and
NMR subsequent distribution is a critical factor for quality
spectroscopy
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assurance. This testing along with in process testing, REFERENCES:
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CONCLUSION:
The pharmacopoeial standards in Ayurvedic
Pharmacopoeia of India are not adequate enough to
ensure the quality of plant materials since the materials
received in the manufacturing premises are not in a
condition that effective microscopic examination can be
done. Therefore chemical, methods, instrumental methods
and then layer chromatographic analysis would determine
the proper quality of plant material

Thus we can ensure consistent quality of herbal product

through following.
Use of approved quality of all raw materials.
Use of all approved packing material.
Standardized and well validated methods of processing
and manufacture.
Complete finished product quality control testing.

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