Iranian Journal of Pharmaceutical Research (2004): Supplement 2:
2nd International Congress on Traditional Medicine and Materia Medica
Towards safe and effective phytomedicines:the need for standardization
El-Azzouny A. M.A.
Division of Pharmaceutical Industries, National Research Center, Cairo, Egypt
Over the past 20 years herbal medicinal products have become a topic of increasing global importance, with both medical and economic implications. In developing countries in Africa and Asia, botanicals have always played a central role in healthcare. Data from WHO suggest that 65 to 80% of the populations in these countries depend on traditional and botanical medicines as the primary source of healthcare. This herbal renaissance has been fueled by strong consumer interest in natural therapies. However, the current lack of uniform quality in botanical products undermines consumer confidence.
If phytopharmaceuticals are to be regarded as rational drugs, they need to be standardized and pharmaceutical quality has to be approved. Medicinal and aromatic plants have to meet the standards set for their evaluation. The best approach that can be proposed for determining the quality of a phytomedicine is the level of active components or key bioactivity markers. Regardless of the form of the botanical, it should be analyzed to ensure that it contains these components at an acceptable standardized level.
There is a growing awareness and acceptance by the pharmaceutical industry as well as by the dietary supplements industry of the absolute need for standardization of botanical extracts and natural products to ensure batch-to-batch consistency.
A major challenge to the industry is the harmonization of standards and methods of standardization of the same product to ensure consistent quality, not only batch-to- batch within a given company, but industry-wide. The methods adopted should take into consideration the need for quality control monitoring over the entire process, from field collection, the selection of the germplasm and cultivation to post harvest processing and manufacture of the final botanical product. The lecture will shed light upon the criteria of quality assurance and quality control of phytomedicines.