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The Use Of Quality Control Parameters In The Evaluation Of Vegetable Crude Drugs
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Medicines containing plant material combined with chemically defined
active substances, including chemically defined, isolated constituents
of plants are not considered to be herbal medicines. Exceptionally, in
some countries herbal medicines may also contain, by tradition, natural
organic or inorganic active ingredients which are not of plant originâ€.
(Copper, et al., 1986).
The use of herbal medicines has increased
remarkably in line with the global trend of people returning to natural
therapies. Herbal medicine products are dietary supplements that people
take to improve their health and are sold as tablets, capsules, powders,
teas, extracts and fresh or dried plants. Herbals are traditionally
considered harmless and increasingly being consumed by people without
prescription. However, some can cause health problems, some are not
effective and some may interact with other drugs. To avoid confusion
with culinary herbs, herbs and plant extracts that have some association
with medicinal uses are called “Herbal Medicinal Productsâ€.
In the
past, the cure of disease and the use of medicinal plants has been much
influenced by religious practice and the exercise of magical rites. From
a pharmacognostical viewpoint, the study of herbal medicines differs
little from that for the allopathic medicinal plants. In practice, many
herbal remedies have not been as extensively studied either
pharmacologically or phytochemically, a situation which must change for
over- the-counter products as stricter licensing controls are
implemented.
During the past decade, there has been increasing public
interest and acceptance of natural therapies in both developing and
developed countries. Due to poverty and limited access to modern
medicine, about 80% of the world’s population, especially in the
developing countries uses herbal medicine as their source of primary
healthcare (Bodeker et al., 2005; Mukherjee, 2002; Farnsworth et al.,
1985; Bisset, 1994). In these communities, traditional medical practice
is often viewed as an integral part of their culture. In the West,
people are attracted to herbal therapies for many reasons, the most
important reason being that, like our ancestors, it is believed they
will help us live healthier lives. Herbal medicines are often viewed as a
balanced and moderate approach to healing. Individuals who use them as
home remedies and over-the-counter drugs spend billions of dollars on
herbal products. As such, they represent a substantial proportion of the
global drug market (WHO, 2005, 2002a, Blumenthal et al., 1998; Roberts
and Tyler, 1997; Farnsworth et al., 1985).
Herbal Medicinal Products (
HMPs) form the largest part of what is sometimes called Complementary
and Alternative Medicine (CAM), and are at one end of a continuum from
“healthy foods†through “nutraceuticals†to “herbal medicinal productsâ€,
which are products that have mainly a use in treating or preventing
disease. However, it should not be forgotten that these advances in
medicine and therapy are easily available to only a minority in the
world as a whole. In many places, mainly in developing countries, but
also in pockets, in every affluent society, herbal products are the
major, if not only, source of medication, for economic or geographical
reasons. This is in contrast to the more affluent areas of the globe
where they are used as a matter of choice rather than necessity. Serious
different reasons have been put forward for the resurgence of interest
in the use of HMPs. This include a reaction against the serious
side-effects sometimes observed when orthodox drugs are used, especially
the more potent ones; the inability of western medicines to treat some
diseases satisfactorily, especially chronic conditions and the generally
mistaken idea that “natural†must be better or safe.
To achieve the
desired benefit from herbal preparations, an individual must take the
required dose over a certain length of time. Although it is generally
believed that most herbal preparations are safe for consumption, some
herbs like most biologically active substances could be toxic with
undesirable side effects (Bisset, 1994).
Herbal treatment is usually
directed towards restoring a state of homeostasis or a normal
physiological balance of the body, rather than directly attacking the
symptoms of the disease. The extracts of the plants prescribed will
contain a wide range of plant metabolites, of which some will be
therapeutically active. This admixture, containing a spectrum of the
constituents of the plants cell may give rise to fewer side-effects than
a single isolated principle. A number of constituents, which on their
own may appear pharmacologically inactive, combine synergistically to
produce therapeutic effects.
In most countries, herbal products are
launched into the market without proper scientific evaluation, and
without any mandatory safety and toxicological studies. There is no
effective machinery to regulate manufacturing practices and quality
standards. Consumers can buy herbal products without a prescription and
might not recognize the potential hazards in an inferior product. A
well-defined and constant composition of the drug is therefore, one of
the most important prerequisites for the production of a quality drug.
Given the nature of products of plant origin, which are not usually
constant and are dependent on and influenced by many factors, ensuring
consistent quality of products is vital for the survival and success of
the industry (Bauer, 1998).
Standardization of herbal formulations is
essential in order to assess the quality of drugs, based on the
concentration of their active principles. Quality evaluation of herbal
preparation is a fundamental requirement of industry and other
organization dealing with ayurvedic and herbal products. The growing use
of botanicals (drug and other products derived from plants) by the
public is forcing moves to assess the health claims of these agents and
to develop standards of quality and manufacture. It is evident that the
herbal industry needs to follow strict guidelines and such regulations
are necessary.
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