STANDARDISATION OF HERBAL MEDICINES

In order to have a common base of understanding on the medicinal use of herbal

plants, drugs and medicinal products derived thereof, one need to have a
common understanding about the definitions for Herbal drug, Herbal drug
preparation and Herbal medicinal product

 DEFINATIONS:

 HERBAL MEDICINES: are medicinal products containing active

substances exclusively herbal drugs or herbal drug preparations.

 HERBAL DRUGS: are plants or part of plants in an unprocessed state,

which are used for medicinal or pharmaceutical purpose. Medicinal
plant, Crude plant material, Vegetable drug, Botanicals, Article of
botanical origin, Herbal substance for Herbal drugs.

 HERBAL DRUG PREPARATIONS: are powdered herbal drugs,

extracts, tinctures, fatty or essential oils, expressed juices, etc prepared
from herbal drugs and preparation whose production involves
fractionation, purification, or concentration process.
  HERBAL MEDICINES: ITS STANDARDISATION AND
QUALITY CONTROL

Herbal drug preparations are supposed to be produced with high “Quality”.

Quality encompasses all the properties of the final product which makes it
optimal suitable for its intended use.
Reproducible quality is a goal, which is, among others, achieved by the
process of standardization.
It is the cardinal responsibility of the regulatory authorities to ensure that the
consumers get the medication, which guarantee Purity, safety, potency and
efficacy. This duty is discharged by the regulatory authorities by rigidity
following various standards of quality prescribed for raw materials and finished
products in pharmacopoeias controlling manufacturing formulate through the
use of formularies and manufacturing operation through statutory imposed
“Good manufacturing practices”. All these procedure logically would be apply
to all type of medication whether included in modern system of medicine or one
of the traditional system such as Ayurvedic system of medicine. The quality
control of crude drugs and herbal formulations is of paramount importance in
justifying their acceptability in modern system of medicine.
The task of lying down standards for quality control of herbal crude and their
formulation involves biological evaluation for a particular disease area,
chemical profiling of the material and lying down specification for the finished
product. Therefore, in case of herbal drugs and product, the word
“Standardization” should encompass entire field of study from cultivation of
medicinal plant to its clinical application.

The term “Standardization” is of outmost importance for achieving high

quality in herbal medicinal products. This expression is generally used to
describe all measures which are taken during the manufacturing process, even
the collecting and processing of the plant starting material, the concomitant
quality control and all steps necessary to insure a homogeneous and
reproducible product.
All considerations and steps used to ensure the achievement of quality, be it
definition of acceptance criteria for starting materials, technical considerations
in designing and validating the manufacturing process, laid down in standard
operating procedures (SOPs), adequate choice of machinery and the entire set
of specifications pertaining to the manufacturing environment, i.e. water, air,
energy, plant and personal hygiene etc., are enclosed in the general term
“Quality assurance”.
The monitoring of adherence to these specifications, part of quality assurance is
defined as “Quality control”.

 DEFINATIONS:

STANDARDIZATION: is a process of evaluating the quality and purity of

Crude drug by means of various parameters like morphological,
microscopically, physical, chemical and biological observation.

In common term it can be explained as 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.
  IMPORTANCE OF STANDARDISATION:

Plants are very complex and vary in their composition, phytochemical content
and therefore in its therapeutic effect. Their therapeutic activity depends on their
chemical constituents, these vary according to age, geographical location and
harvesting processes. Also improper authentication of herbs, adulterations by
microorganism, pesticide residue, has made standardization of herbal drug of
primary importance.

In olden times, vaidyas used to treat patients on individual basis, and prepare
drug according to the requirement of the patient. But the scenario has changed
now; herbal medicines are being manufactured on the large scale in
Pharmaceutical units, where manufacturers come across many problems such as
availability of good quality raw material, authentication of raw material,
availability of standards, proper standardization methodology of single drugs
and formulation, quality control parameters.

In almost all the traditional system of medicine, the quality control aspect has
been considered from its inspection by Rishis, Vaidyas and Hakims. However,
in modern concept it require necessary changes in their approach, by that way a
concrete method of quality control in terms of development of modern
methodologies. Thus today quality assurance is thrust area for the evaluation of
traditional used medicinal plants and herbal formulation.

Herbal medicines have made a great contribution towards maintaining human

health. In the western world, as the people are becoming aware of the potency
and side effect of synthetic drugs, there is an increasing interest in the natural
product remedies with a basic approach towards the nature. People all over the
world have realised that the vast plant wealth has much to offer in the shape of
new and effective remedies which are safe and accessible to masses.

Unfortunately, no serious efforts have been taken to verify these claims and to
develop validated, standardised herbal preparations for effective cure and
management of diseases. No official standard are available for the herbal
formulations.
Although there are many formulations available in market but they are
scientifically neither evaluated nor authenticated or quality controlled.
Manufactures those who are doing some testing of their formulation, have fixed
their own parameter, most of them are only preliminary in nature. Further, there
is extremely limited knowledge about the ingredients in the herbal drug
formulation and also about their effects on humans. Toxicological or safety data
of herbal drugs for all practical purpose is unknown or not available.

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. Adding to this variability is the fact that in herbal
medicine several plants may be used together in the same preparation. In
polyherbal preparations it will be very difficult to estimate each and every
ingredient in term of their chemical constituent.
This means that there should be a quality control test for the entire preparation
to ensure quality of the product.

 CURRENT REGULATIONS FOR STANDARDIZATION OF CRUDE

DRUGS:
  Several pharmacopoeias have provided monographs stating
parameter and standard of many herbs and some product made out
of these herbs. Several pharmacopoeias like:

 Pharmacopoeia Committee
 Chinese Herbal Pharmacopoeia
 United States Herbal Pharmacopoeia
 British Herbal Pharmacopoeia
 British Herbal Compendium
 Japanese Standards for Herbal Medicine
 The Ayurvedic Pharmacopoeia of India (API)

 Lay down monograph for herbs and herbal products to maintain

their quality in their respective nations. Government of India too
has brought out Ayurvedic Pharmacopoeia India, which
recommends basic quality parameters for eighty common
Ayurvedic herbal drugs.

 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. Chaudhury RR, Herbal medicine for human health. World Health Organization
Geneva, CBS publishers and distributors LTD New Delhi, 1999 2. Raina MK, Quality control of herbal and herbo-

mineral formulations. Indian journal of natural products, 2003; 19:11-15.

 WHO HAS SET CERTAIN STANDARDS/GUIDELINES FOR

HERBAL DRUGS STANDARDISATION:

Accounting to WHO it is the process involving the physicochemical evaluation

of crude drug covering the aspects, as selection and handling of crude material,
safety, efficacy and stability assessment of finished product, documentation of
safety and risk based on experience, provision of product information to
consumer and product promotion.

I. AUTHENTICATION : For Identification of right variety and search

of adulterants.
 II. BOTANICAL PARAMETERS:
 Sensory evaluation: Includes visual macroscopy, touch, odour,
taste, etc.
 Foreign matter : includes foreign plants, materials etc.
 Microscopy : Includes histological observations and
measurements.
III. Physio- chemical parameters:
 TLC/HPTLC fingerprints
 Ash value : Total ash, acid insoluble, water soluble ash
value
 Extractive values : In different solvents
 Moisture content and volatile matter
 Volatile oils
IV. Pharmacological Parameters
 Bitterness valve
 Astringent property
 Swelling index
 Foaming index
V. Toxicological Parameters
 Arsenic
 Pesticide residue : Mainly DDT, BHC, Aldrin causing side
effects in humans
 Heavy metals : Like cadmium, Lead etc.
 Microbial contamination: Total viable count of pathogens like
E.col, salmonella, S.aureaus etc.
 Aflatoxin : By TLC
 Radioactive contamination
 References:
1. Agarwal, A., 2005. Critical issues in Quality Control of Herbal Products,
Pharma Times, 37(6), Pp 09-11.
2. Sane, R.T., 2002. Standardization, Quality Control and GMP for Herbal
drugs, Indian Drugs, 39 (3), 184-190.
3. Florey, H. W., Chain, E. and Florey, M. E., 1949. Vol. 1. The antibiotic,
Oxford University Press. New York. P p. 576-628.
4. Chaudhari, R. D., 1996. Herbal drug industry, 1st Edn., Eastern Publisher,
New Delhi, 498-499.
5. Chakravarthy, B. K., 1993. Standardization of Herbal products. Indian. J.
Nat. Product, 9, 23-26.