Abstract
It is important to study the stability of plant extracts used as active ingredients in phytotherapic medicine, as degradation of the active principles directly affects the efficacy and safety of these products. Therefore, a stability study of the hydroalcoholic extract of the species: Mikania glomerata and Mikania laevigata was conducted in order to determine the speed of degradation and shelf life of these extracts, which are incorporated in cough syrup in Brazil. Leaves of both species were dried in an oven or by lyophilization (freeze-dried). Hydroalcoholic extracts underwent both accelerated stability study of six months and long-term stability study for 12 months. Samples were stored at different temperatures and every three months were analysed by ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS) to monitor their chemical profile, quantifying coumarin and chlorogenic acid. For all conditions of the study, a reduction of the content of the chemical marker of this species, coumarin, greater than 5% was observed, so a shelf life of two years cannot be assigned to the hydroalcoholic extracts of these species as observed in commercial extracts.
Highlights
In Brazil, two species of Mikania, popularly known as guaco are available and widely used in popular medicine in extemporary preparations such as tea and homemade syrups for the treatment of diseases of the airways, due to their bronchodilator effect (Silva et al, 2008)
Given the lack of studies evaluating the stability of extracts of M. glomerata and M. laevigata, prepared according to pharmacopoeia standards, the objective of this work was to study the stability of hydroalcoholic extracts of M. glomerata and M. laevigata in accordance with the provisions of the Guide for conducting Stability Studies Resolution (Brasil, 2005) accompanying the content of their official chemical marker, coumarin
The drying method only slightly affected the solid residue, as reported previously: 1.3% (w/v) for oven dried M. glomerata compared to 1.4% (w/v) for freezedried M. glomerata, and 1.2% (w/v) for oven dried M. laevigata to 1.3% (w/v) for freeze-dried M. laevigata
Summary
In Brazil, two species of Mikania, popularly known as guaco are available and widely used in popular medicine in extemporary preparations such as tea and homemade syrups for the treatment of diseases of the airways, due to their bronchodilator effect (Silva et al, 2008). A norm, published by the Brazilian government agency classified 36 medicinal plants as safe and effective and only the manufacturing process and quality control need be detailed for their registration. These plants have streamlined registration, including M. glomerata, enabling their industrial production (ANVISA, 2008). Another resolution establishes the minimum requirements for the registration of herbal medicine and lists the documents required for registration (ANVISA, 2010), including results of accelerated stability study or the long-term stability studies, according to Government standards (Brasil, 2005)
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