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The technical standardization of an intermediary of a phytomedicine is a decisive step for the quality standard that the product will show. After the validation of the alleged use, popular form of use, posology and agronomic certification of the plant material, for which phytochemical and pharmacognostic pattern will be developed to monitor the physical, chemical and physico-chemical characteristics of the plant, ensuring homogeneity of samples and the similarity to specimens tested in experimental stage. The plant material is then extracted and the obtained extract is used in the development of the formulation. This extract must be in accordance to the Brazilian Pharmacopoeia, respecting as far as possible the characteristics of the popular form of use. Before the next step, the pharmacotechnical handling, the extract will be phytochemically analysed, in order to determine the metabolic substance classes present in the sample. Then it must be pharmacologically investigated to assure that its activity, is similar to that originally alleged and experimentally tested; its physical and physico-chemical characteristics will be determined, and, subsequently, the extract undergoes chemical and chromatographic analysis to have identified substances that could characterize the plant and serve as chemical and, preferably, pharmacological quality markers. Substances which are chemically stable, responsible for the activity to be presented by the phytomedicine and able to be detectable and quantifiable by usual analytical methods, such as chromatography and ultraviolet spectroscopy or mass spectrometry, are potential candidates to be used as markers.

Standardization of Herbal Drugs Derivatives with Special Reference to Brazilian Regulations