Razvoj i validacija HSS-GC-FID metode za određivanje sadržaja lakohlapljivih sastavnica sirupa za iskašljavanje za djecu

Abstract

A cough syrup is a medicinal product used in an attempt to treat coughing and related conditions. Traditional herbs are used for preparation of cough syrup. There are two main categories of herbs that are used in preparation of cough remedies: expectorants and antitussives. For productive coughs, treatment with expectorants may be attempted to loosen mucus from the respiratory tract. For dry coughs antitussives are used to suppress the body’s urge to cough. Herbal medicinal products may contain significant levels of ethanol arising from its use as an extraction solvent in liquid extracts and tinctures. Although the use of ethanol is necessary for extraction of pharmacologically active compounds, it was found that some herbal medicinal products contain large amounts (up to 60 %) of ethanol with even less clinical need or benefit. In young children ingestion of even modest amounts of ethanol may lead to permanent neurological damage as result of hypoglycemia. Therefore, special attention should be given to the ethanol content of herbal medicinal products for pediatric use. At the moment the safety evaluation of the ethanol content of herbal medicinal products for pediatric use is not harmonized between different European Union Member States. Moreover, the lack of guidelines relating to safe limits of ethanol as part of herbal medicinal products for pediatric use has also led to different national labeling practices. Therefore, the aim of our work was to develop and validate a new HSS-GC-FID method for quantification of ethanol and its main impurity, methanol, present in children’s cough syrup