薬物疫学と医薬品の安全性の進歩

概要

Comparison among Reference, Generic and Similar Drugs from the Same Active Substance

Suzana O. Santos*, Vivianne L. B de Souza, Romiton dos S. Amaral

Trace metals are among the toxic substances that cause intoxication of the human organism. They are highly reactive and bioaccumulative. However, living things require small amounts of some metals, including Co, Cu, Mn, Mo, V, Sr, and Zn, to perform vital functions. Other metals such as mercury, lead and cadmium, have no function to organic systems, and their accumulation may cause several pathologies. Trace metals are also part of pharmaceutical preparations found as contaminants from machinery, handling or medicinal plants extracts. The presence of metals in medicines has become a relevant subject to evaluate the degree of exposure and possible consequences for human health. The objective of this study was to obtain trace metals in drugs. Three drugs with different active principles from different laboratories (one reference, one generic and one similar, each) were acquired in different drugstores in the metropolitan region of Recife-PE. The samples purchased were crushed to obtain 100 mg and prepared in polyethylene tubes, covered with polypropylene film for analysis in EDXRF. Results demonstrated the presence of Al>P>M>Zn>Ba>Sr>Cu>Ni>Se>Sb>Ce>Cs>Rb>Co>Mo>U>Th>Cs in generic Captopril. However, in similar Captopril were found in decreasing order: Fe>Mg>Al>La>K>Zn>Sr>Cu>Co>Ni>Rb>Ba>Ce>Se>Sb>U>Th>Mo. High levels of zinc and iron suggest contamination from machines. High concentrations of Aluminum and Iron, in the body, could cause neurodegenerative diseases like Alzheimer's disease and others pathologies. Thorio and Uranium as radionuclides have been found in few amounts, so that, these metals do not cause health damages, however, Nickel, Copper and Chromium could cause gastrointestinal and respiratory problems and anemia.