| Popis: |
During the last fifteen years we assisted at an incredible expansion of formulations containing botanical derivatives, marketed mainly as nutritional supplements (food and dietary supplements) around the world. This rapid and unpredictable development changed several criteria of management for botanical products. The legislators have today the problem to write down new rules to protect the consumers from. frauds or dangerous side effects. The tendency around the world is the harmonization of the basic concepts concerning the safety firstly and later the efficacy of a pletora of products. Due to the confusion created by the big demand and by the speculation, bad quality products were put on the shelf, destroying step by step the credibility of many preparations. The main problem is the safety: the use of uncontrolled products, prepared from any kind of plant material without biological test and GMP preparation method, caused a consistent number of side effects. To gain the confidence of the consumers, now we have to go back at the origin for the preparation of botanical extracts, following the rigorous concepts of their standardization and biological evaluation of their tolerability and efficacy. It is very important to keep in mind that changing the preparation method of a given extract very often, the biological profile of the final product can change dramatically. The presence of the unknown substances could have an important role and, for these reasons, in the characterization of the extracts, NMR an NIR spectroscopy have been introduced. As a practical example of how we can manage this, I would like to consider the preparation of the Ginkgo biloba extract and of the Hypericum perforatum, Serenoa repens one which are very popular products, marketed in several countries both as a prescription drug and/or as a health food product. |
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