WEIGHT LOSS FOOD SUPPLEMENTS: ADULTERATION AND MULTIPLE QUALITY ISSUES IN TWO PRODUCTS OF CHINESE ORIGIN

Abstract

One of the most serious quality issues associated with herbal products used for healthcare purposes is the deliberate adulteration with synthetic substances, meant to increase the efficacy of respective products in the claimed indications. Here we report on adulteration with sibutramine and phenolphthalein in two herbal food supplements of Chinese origin, widely distributed through internet in various countries, promoted for weight loss. An HPLC method developed and validated by the authors was used for the separation and assay of the two substances. The average content per capsule for one of the two products, determined through this method was 24.71 mg sibutramine and 48.20 mg phenolphthalein. We also determined flavonoids (through a spectrophotometric method), uniformity of mass (according to European Pharmacopoeia, 6 th edition) and performed a microscopical examination of the capsule content. The results raised concerns regarding the quality of the two products. Furthermore, an analysis of the clinical and non-clinical data available in the scientific literature for the herbal ingredients of the two products has shown that it is very unlikely that, in the amounts of the current formulations and posology, the products have weight loss inducing effects. Rezumat Una dintre problemele de calitate cele mai grave specifice produselor pe baza de plante utilizate in ingrijirea sanataţii o reprezinta falsificarea deliberata cu substanţe sintetice, destinata sa creasca eficacitatea produselor respective in indicaţiile in care sunt promovate. Lucrarea de faţa descrie falsificarea cu sibutramina si fenolftaleina a doua suplimente alimentare pe baza de plante, de origine chineza, distribuite pe scala larga prin intermediul internetului in diferite ţari si promovate pentru pierderea in greutate. Pentru separarea si cuantificarea celor doua substanţe s-a utilizat o metoda HPLC dezvoltata si validata de autori. Conţinutul mediu pe capsula pentru unul dintre cele doua produse, determinat prin aceasta metoda a fost de 24,71 mg sibutramina si 48,20 mg fenolftaleina. S-au determinat si flavonele (printr-o metoda spectrofotometrica) si uniformitatea masei (conform Farmacopeei Europene, ediţia a 6-a) si s-a efectuat un examen microscopic al conţinutului capsulelor. Rezultatele genereaza ingrijorari cu privire la calitatea celor doua produse. Mai mult, o analiza a datelor clinice si non-clinice disponibile in literatura de specialitate pentru ingredientele vegetale ale celor doua produse a aratat ca este foarte puţin probabil ca, in cantitaţile din formulele actuale si cu posologia actuala, produsele sa poata induce pierderea greutaţii corporale.