Genetic Identification and Validation of Echinacea Species

This technology is a method for identification and validation of echinacea species. It includes primers based on information analysis of sequences from a large number of echinacea species to amplify certain segments of genomic DNA to identify the species.Primers and methods are also disclosed to amplify other plant species that are frequently found in adulterated herbal samples of echinacea.

The use of dietary supplements, particularly vitamins and botanicals, have become very popular in the United States and Europe. Supplements containing the Purple Coneflower, Echinacea purpurea and other related species, is one of the top selling products. Public safety and product efficacy demand uniform state-of-the-art quality assurance programs. In fact, the Food and Drug Administration has a mandate to begin regulation of the dietary supplement industry for quality assurance and good manufacturing practices.With the implementation of regulations to ensure quality control of product manufacture of phytomedicinals (21 CFR 201.128, Food & Drug Cosmetic Act), species certification is likely to be required of all botanical raw materials.However, even if it is not required by the FDA, such certification increases consumer confidence and provides a competitive market advantage for producers of the certified product.

The currently practiced methods for identification of botanical species from processed plant materials (dried roots, stems, fleaves, flower and seed) involve the chemical identification of chromatographic profiles of plant secondary products. These chromatographic techniques include thin-layer chromatography (TLC) and high performance liquid chromatography (HPCL). The identification of a plant species is accomplished by comparison of chemical constituent profiles with chemical standard mixtures derived from extracts of a voucher plant specimen. Confirmations are often made by microscopic evaluation of the processsed plant material. The results obtained from such analysis are subject to error and misinterpretation because many plant secondary products are common within families and genera, and their natural variability can be influenced by growth cycle and habitat.

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