Određivanje udjela metanola i etanola plinskom kromatografijom u farmaceutskim proizvodima s propolisom

master's thesis

• Title (english): Determination of methanol and ethanol content in pharmaceutical products with propolis
• Author: Ivana Novak
• Mentor: Miranda Sertić (mentor)
• Committee member: Miranda Sertić (predsjednik povjerenstva)
• Committee member: Iva Mucalo (član povjerenstva)
• Committee member: Ana Mornar Turk (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical analysis); Zagreb
• Defense date and country: 2016-03-10, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Na tržištu se nalazi mnogo farmacutskih proizvoda koji sadrže propolis, dodan najčešće u obliku etanolnog ekstrakta. Zbog mogućnosti da se pri pripremi propolisa ne koristi etanol odgovarajuće čistoće ili dođe do nehotične zamjene s denaturiranim etanolom, moguća je pojava onečišćenja koja utječu na kvalitetu i sigurnost primjene gotovog proizvoda. Najčešće i očekivano onečišćenje u etanolu je metanol. Zbog mogućih toksičnih učinaka etanola i metanola, cilj rada bio je odrediti sadržaj metanola i etanola u farmaceutskim proizvodima s propolisom primjenom plinske kromatografije s headspace uzorkovanjem. Ova tehnika je odabrana jer omogućuje analizu hlapljivih tvari u složenim uzorcima uz vrlo malu prethodnu obradu uzorka.
Za analizu 24 uzorka s propolisom korištena je prethodno razvijena i validirana HSS-GC-FID metoda za određivanje sadržaja etanola i metanola u tekućim uzorcima. Podaci o sadržaju etanola i metanola dobiveni su računski uz pomoć jednadžbi kalibracijskih pravaca. Na temelju dobivenih rezultata, ustanovljeno je da svi analizirani uzorci sadrže etanol u rasponu od 0,01 do 75,96% v/v. Kod pojedinih uzoraka, u kojima je bila prisutna veća količina etanola, očekivano je pronađen i metanol u rasponu od 0,003 do 0,026% v/v.
Kod većine analiziranih uzoraka etanol nije bio deklariran, ili je njegova količina bila netočno navedena, čak i kod proizvoda namijenjenih djeci. Metanol, pronađen u nekoliko uzoraka, nije premašivao dopuštene granice. Iako se ne radi o količinama etanola opasnim za odrasle, kod djece puno manje količine mogu dovesti do akutnog trovanja. Prema smjernicama neki od ispitanih proizvoda ne bi se smjeli koristiti kod djece i morali bi biti pakirani sa zaštitnim zatvaračem. Radi se o proizvodima koji ne podliježu strogoj zakonskoj regulativi kao lijekovi, a potrošači manje obraćaju pažnju na pravilno doziranje i čuvanje zbog uvriježenog mišljenja da su dodaci prehrani prirodni, pa stoga i sigurni proizvodi. Rezultati ovog istraživanja upućuju na zaključak da je potrebna redovita kontrola ovih proizvoda.

Abstract (english)

Many pharmaceutical products on the market contain propolis, usually added in the form of ethanolic extract. Because of possibility that during preparation of propolis ethanol of inadequate purity was used or was inadvertently replaced with denatured ethanol, there is a possibilily of contamination affecting the quality and safety of the finished products. The expected and most commonly found contamination in ethanol is methanol. Because of potential toxic effects of ethanol and methanol, goal of this thesis was to determine content of methanol and ethanol in pharmaceutical products with propolis using gas chromatography with headspace sampling. This technique was chosen because it allows analysis of volatile compounds in complex samples with very little pretreatment of samples.
A previously developed and validated HSS GC-FID method for determination of ethanol and methanol content in liquid samples was used for analysis of 24 samples with propolis. Data on content of ethanol and methanol was obtained by calculation using calibration equations. Based on the results, it was found that all analyzed samples contained ethanol in a range from 0.01 to 75.96% v/v. In some samples which contained a large amount of ethanol, methanol was found, as expected, ranging from 0.003 to 0.026% v/v.
In most of analyzed samples ethanol was not declared, or it´s amount was incorrectly listed, even in products intended for children. Methanol, found in several samples, did not exceed the permitted levels. Although determined quantites of ethanol were not dangerous for adults, much smaller amounts can cause acute poisoning in children. According to guidelines some of the tested products should not be used in children and need to be packaged with a safety cap. As these poducts are not subject to strict legal regulations as medicines, and because general attitute and belief is that those supplements are natural and hence safe products, consumers pay less attention to correct dosing and storage of such products. Results of this thesis indicate that regular inspection of these products is needed.

• Keywords: etanol; metanol; propolis; headspace; dodaci prehrani; plinska kromatografija
• Keywords (english): ethanol; methanol; propolis; headspace; dietary supplements; gas chromatography
• Language: croatian
• URN:NBN: urn:nbn:hr:163:511482
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2016-06-13 15:47:39