Illegal market of products for treatment of chronic pain: a case study

Resumo

The present study reports a case through an analysis and discussion on legal and phytochemical fields on a product marketed for treatment of chronic pain (Natural Life Harp capsules 100 mg). Analyses were performed from legal aspect, besides the product phytochemical screening and qualitative analysis of the drugs (steroids/anti-inflammatory). In the legal context, the standards set by the National Health Surveillance Agency (Anvisa) were consulted. During the phytochemical screening were performed reactions for identification of saponins, steroids and triterpenoids (Liebermann-Burchard), anthraquinones (Born Traeger), flavonoids (Shinoda), tannins and polyphenols (ferric chloride), carbohydrates (Fehling) and alkaloids (Drangedorf, Mayer and Bertrand) in comparison with a standard sample of Uncaria tomentosa held by merchants as a constituent of formulation. Samples and standards of anti-inflammatory steroids were diluted in hexane:ethyl acetate (8:2) then applied on sheet chromatography of silica gel and eluted with dichloromethane: methanol (95:5). At the end, it was sprayed on the plate a solution of ceric sulfate for better visualization under UV light. Product without registration in Brazil, and outside the standards set for labeling and packaging by Anvisa, was considered illegal. Phytochemical screening revealed the absence of all secondary metabolites analyzed in contradiction to that observed in plant extract of Uncaria tomentosa. This revealed the presence of anthraquinones, tannins and polyphenols. Regarding presence of synthetic drugs, the results indicated the presence of diclofenac and piroxicam. Thus the evaluated product was considered as adulterated and out of the legal requirements, confirming the need for strict monitoring to protect the health of the population.