-
The Use Of Quality Control Parameters In The Evaluation Of Vegetable Crude Drugs
CHAPTER ONE -- [Total Page(s) 6]
Page 6 of 6
-
-
-
1.7 PURITY DETERMINATION
Purity is
closely linked with the safe use of drugs and deals with factors such
ash values, contaminants (e.g. foreign matter in the form of other
herbs), and heavy metals. However, due to the application of improved
analytical methods, modern purity evaluation also includes microbial
contamination, aflatoxins, radioactivity, and pesticide residues.
Analytical methods such as photometric analysis, thin layer
chromatography (TLC), high performance liquid chromatography (HPLC), and
gas chromatography (GC) can be employed in order to establish the
constant composition of herbal preparations(Kunle, et al . , 2012).
High
Performance thin layer chromatography (HPTLC) is valuable quality
assessment tool for the evaluation of botanical materials. It allows for
analysis of a broad number of compounds both efficiently and cost
effectively. With HPTLC, the same analysis can be viewed using different
wavelengths of light thereby providing a more complete profile of the
plant than is typically observed with more specific type of analyses
(Chakravarth, 1993).
1.8 W.H.O GUIDELINES FOR QUALITY STANDARDIZED HERBAL FORMULATIONS
WHO
has evolved guidelines to support the member states in their efforts to
formulate national policies on traditional medicine and to study their
potential usefulness including evaluation, safety, and efficacy.
Standardization and quality control parameter for herbal formulations
are based on the following fundamental parameters:
Quality control of crude drugs material, plant preparations and finished products.
Stability assessment and shelf life.
Safety assessment; documentation of safety based on experience or toxicological studies.
Assessment of efficacy by ethno medical information and biological activity evaluations.
1.9 QUALITY CONTROL OF CRUDE MATERIALS
Quality
can be defined as the status of a drug that is determined by identity,
purity, content, and other chemical, physical, or biological properties,
or by the manufacturing processes. Quality control is a term that
refers to processes involved in maintaining the quality and validity of a
manufactured product.
The quality of herbal medicine that is. the
profile of the constituents in the final product has implication in
efficacy and safety. Quality controls of synthetic drug offer no
problems with very well defined parameters of analysis. In contrast,
herbal products represent a number of unique problems when quality
aspects are considered. These are because of the nature of the herbal
ingredients present therein, which are complex mixtures of different
secondary metabolites that can vary considerably depending on
environmental and generic factors. Furthermore, the constituents
responsible for the claimed therapeutic effects are frequently unknown
or only partly explained. These complex positions of quality aspects of
herbal drugs are further complicated by the use of combination of herbal
ingredients as are being used in traditional practice. It is not
uncommon to have as many as five different herbal ingredients in one
product. Thus batch to batch variation starts from the collection of raw
material itself in the absence of any reference standard for
identification. These variations multiply during storage and further
processing.
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 (Wani, 2007).
To ensure safety and quality of
the medicinal plants it is necessary to focus on all aspects of
medicinal plant research from ethno – pharmacology, utilization,
isolation and identification of active constituents to efficacy
evaluation, safety, formulation and clinical evaluation. Quality control
of the medicinal plants starts right at the source of the plant
material. The phytochemical composition of the plant material and the
resulting quality can vary due to several factors including a number of
environmental factors such as geographical location, soil quality,
temperature and rainfall etc. taxonomy, the time of collection, method
of collection, cultivation, harvesting, drying and storage conditions,
preparation and processing methods can also affect composition.
Contamination by microbes, chemical agents such as pesticides and heavy
metals as well as by insects and animals during any of these stages can
also lead to poor quality of the finished products. Standardization of
all these factors is necessary to meet the current standards of quality,
safety and efficacy (Brijesh et al., 2006).
CHAPTER ONE -- [Total Page(s) 6]
Page 6 of 6
-
