Control de calidad de tres medicamentos naturales sólidos orales con actividad antihipertensiva comercializados en el mercado nacional

Abstract

The main objective of this research study was to perform quality control of three oral solid natural drugs with antihypertensive activity marketed in the national market. The production of natural medicines faces several quality challenges due to factors such as inadequate collection of raw materials, poor storage, inefficient manufacturing practices, and microbiological contamination. Lack of adequate supervision can result in products that do not meet the physicochemical and microbiological standards necessary to ensure their safety and efficacy. The methodology implemented had a qualitative and quantitative approach, with an experimental and descriptive design. The study population consisted of three natural drugs manufactured by laboratories in Ecuador. Physicochemical and microbiological analyses were carried out, in addition to the determination of elemental impurities and secondary metabolites. Through these tests, active compounds with antihypertensive activity were qualitatively identified, including alkaloids, flavonoids, tannins, saponins, free amino acids, coumarins, quinones and anthocyanins. One of the products was found not to meet the required hardness parameters. In addition, two of the samples showed contamination exceeding acceptable limits for molds and yeasts, and microorganisms such as Staphylococcus aureus and Escherichia coli were detected in two samples. However, the levels of lead, mercury, cadmium and arsenic in all three samples were within the established limits. In this context, it was concluded that the products do not comply with several quality parameters and may represent a health risk to consumers.