Control de calidad de tres fitofármacos sólidos orales con actividad antiparasitaria comercializados en el mercado nacional

Abstract

The main objective of the present research project was to focus on the quality control of three oral solid phytopharmaceuticals with antiparasitic activity marketed at national level was carried out, comparing their characteristics with the specifications of pharmacopoeias. The lack of human, technical and financial resources makes it difficult to carry out rigorous quality controls in the production of phytopharmaceuticals, which represents a health risk. This study included physicochemical (loss on drying, disintegration, friability, breaking strength, weight variation), microbiological and phytochemical tests. The results showed that none of the three samples met all the established quality parameters, detecting variations in the physicochemical tests, specifically in loss on drying, in samples A, B and C, with values of 5.4440%, 5.5273% and 7.5897%, respectively. Also, in the friability test in sample B with 1.9574% and sample C, with the fracture of two tablets, suggesting problems in the manufacturing processes. In addition, the presence of Staphylococcus aureus was identified in the three samples. On the other hand, phytochemical analysis revealed the presence of various secondary metabolites, among the common metabolites in the three samples were alkaloids, tannins, cholesterol, flavonoids, coumarins, anthocyanidins. These compounds, commonly found in paico, the main component of these phytopharmaceuticals, have been associated with antiparasitic properties in the scientific literature. Likewise, the presence of heavy metals (lead, cadmium, arsenic and mercury) was evaluated, and the samples studied were within the range of the permissible daily dose. Finally, the deficiencies found in the physicochemical and microbiological analyses, evidenced a generalized non-compliance with the pharmacopoeial standards by the three evaluated phytopharmaceuticals.