Evaluation of safety profile of the essential oils of eight Heracleum taxa (Apiaceae) related to determined furanocoumarin content
Procena bezbednosnog profila etarskih ulja osam taksona roda Heracleum (Apiaceae) u odnosu na utvrđeni sadržaj furanokumarina
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Метаподаци
Приказ свих података о документуАпстракт
For essential oils of roots, leaves, flowers and fruits of eight Heracleum taxa (H.sphondylium, H. sibiricum, H. montanum, H. ternatum, H. pyrenaicum subsp. pollinianum, H. pyrenaicum subsp. orsinii, H. verticillatum and H. orphanidis), we previously demonstrated antimicrobial, cytotoxic (selective to cancer cells) and/or antioxidant activities. In this work, for these essential oils maximum daily intake related to total furanocoumarins (FCs) content was estimated, according to Committee on Herbal Medicinal Products of European Medicines Agency (EMA/HMPC) recommendations. FCs were quantified using gas chromatography, and their sum equivalent to xanthotoxin (8-methoxypsoralen, 8-MOP) was calculated. It was shown that daily intake, not contributing significantly to overall risk (equivalent to intake of 1.5 mg FCs) for root essential oils was in the range of 1.94-5.23 mL, for fruit oils of 5.23-15.68 mL and for leaf or flower oils of 2.90-15.68 mL. Daily intak...e, not posing any unacceptable risk (equivalent to intake of 15 μg FCs) for root oils was in the range of 0.02-0.05 mL, for fruit oils of 0.05-0.16 mL and for leaf or flower oils of 0.03-0.16 mL. This work demonstrates the application of current EMA/HMPC recommendations, in order to establish safety profile of herbal preparations containing FCs.
Za etarska ulja korena, listova, cvasti i plodova osam taksona roda Heracleum
(H. sphondylium, H. sibiricum, H. montanum, H. ternatum, H. pyrenaicum subsp. pollinianum,
H. pyrenaicum subsp. orsinii, H. verticillatum i H. orphanidis) prethodno su pokazane
antimikrobna, citotoksična (selektivna prema tumorskim ćelijama) i/ili antioksidantna aktivnost.
Cilj ovog rada bio je da se ustanovi maksimalni dozvoljeni dnevni unos etarskih ulja u odnosu
na utvrđeni sadržaj ukupnih furanokumarina, u skladu sa preporukama Komiteta za biljne
lekovite proizvode Evropske agencije za lekove (EMA/HMPC). Furanokumarini su
kvantifikovani gasnom hromatografijom i njihov ukupni sadržaj izražen je kao ksantotoksin (8-
metoksipsoralen, 8-MOP). Dnevni unos ispitivanih etarskih ulja koji ne doprinosi značajno
ukupnom riziku (ekvivalentan unosu 1,5 mg furanokumarina izraženih kao 8-MOP), kreće se u
opsegu 1,94-5,23 mL za etarska ulja korena, 5,23-15,68 mL za ulja plodova i 2,90-15,68 mL za
ulja listova... ili cvasti. Dnevni unos etarskih ulja koji ne predstavlja nikakav rizik (ekvivalentan
unosu 15 μg furanokumarina izraženih kao 8-MOP), kreće se u opsegu 0,02-0,05 mL za etarska
ulja korena, 0,05-0,16 mL za ulja plodova i 0,03-0,16 mL za ulja listova ili cvasti. Ovaj rad
demonstrira primenu aktuelnih EMA/HMPC preporuka u cilju utvrđivanja bezbednosnog
profila biljnih preparata u kojima su detektovani furanokumarini.
Кључне речи:
Heracleum / essential oils / furanocoumarins / 8-MOP / safety profileИзвор:
Arhiv za farmaciju, 2019, 69, 3, 165-175Издавач:
- Beograd : Savez farmaceutskih udruženja Srbije
Финансирање / пројекти:
- Испитивање лековитог потенцијала биљака: морфолошка, хемијска и фармаколошка карактеризација (RS-173021)
Институција/група
PharmacyTY - JOUR AU - Ušjak, Ljuboš AU - Drobac, Milica AU - Niketić, Marjan AU - Petrović, Silvana PY - 2019 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3474 AB - For essential oils of roots, leaves, flowers and fruits of eight Heracleum taxa (H.sphondylium, H. sibiricum, H. montanum, H. ternatum, H. pyrenaicum subsp. pollinianum, H. pyrenaicum subsp. orsinii, H. verticillatum and H. orphanidis), we previously demonstrated antimicrobial, cytotoxic (selective to cancer cells) and/or antioxidant activities. In this work, for these essential oils maximum daily intake related to total furanocoumarins (FCs) content was estimated, according to Committee on Herbal Medicinal Products of European Medicines Agency (EMA/HMPC) recommendations. FCs were quantified using gas chromatography, and their sum equivalent to xanthotoxin (8-methoxypsoralen, 8-MOP) was calculated. It was shown that daily intake, not contributing significantly to overall risk (equivalent to intake of 1.5 mg FCs) for root essential oils was in the range of 1.94-5.23 mL, for fruit oils of 5.23-15.68 mL and for leaf or flower oils of 2.90-15.68 mL. Daily intake, not posing any unacceptable risk (equivalent to intake of 15 μg FCs) for root oils was in the range of 0.02-0.05 mL, for fruit oils of 0.05-0.16 mL and for leaf or flower oils of 0.03-0.16 mL. This work demonstrates the application of current EMA/HMPC recommendations, in order to establish safety profile of herbal preparations containing FCs. AB - Za etarska ulja korena, listova, cvasti i plodova osam taksona roda Heracleum (H. sphondylium, H. sibiricum, H. montanum, H. ternatum, H. pyrenaicum subsp. pollinianum, H. pyrenaicum subsp. orsinii, H. verticillatum i H. orphanidis) prethodno su pokazane antimikrobna, citotoksična (selektivna prema tumorskim ćelijama) i/ili antioksidantna aktivnost. Cilj ovog rada bio je da se ustanovi maksimalni dozvoljeni dnevni unos etarskih ulja u odnosu na utvrđeni sadržaj ukupnih furanokumarina, u skladu sa preporukama Komiteta za biljne lekovite proizvode Evropske agencije za lekove (EMA/HMPC). Furanokumarini su kvantifikovani gasnom hromatografijom i njihov ukupni sadržaj izražen je kao ksantotoksin (8- metoksipsoralen, 8-MOP). Dnevni unos ispitivanih etarskih ulja koji ne doprinosi značajno ukupnom riziku (ekvivalentan unosu 1,5 mg furanokumarina izraženih kao 8-MOP), kreće se u opsegu 1,94-5,23 mL za etarska ulja korena, 5,23-15,68 mL za ulja plodova i 2,90-15,68 mL za ulja listova ili cvasti. Dnevni unos etarskih ulja koji ne predstavlja nikakav rizik (ekvivalentan unosu 15 μg furanokumarina izraženih kao 8-MOP), kreće se u opsegu 0,02-0,05 mL za etarska ulja korena, 0,05-0,16 mL za ulja plodova i 0,03-0,16 mL za ulja listova ili cvasti. Ovaj rad demonstrira primenu aktuelnih EMA/HMPC preporuka u cilju utvrđivanja bezbednosnog profila biljnih preparata u kojima su detektovani furanokumarini. PB - Beograd : Savez farmaceutskih udruženja Srbije T2 - Arhiv za farmaciju T1 - Evaluation of safety profile of the essential oils of eight Heracleum taxa (Apiaceae) related to determined furanocoumarin content T1 - Procena bezbednosnog profila etarskih ulja osam taksona roda Heracleum (Apiaceae) u odnosu na utvrđeni sadržaj furanokumarina VL - 69 IS - 3 SP - 165 EP - 175 DO - 10.5937/arhfarm1903165U ER -
@article{ author = "Ušjak, Ljuboš and Drobac, Milica and Niketić, Marjan and Petrović, Silvana", year = "2019", abstract = "For essential oils of roots, leaves, flowers and fruits of eight Heracleum taxa (H.sphondylium, H. sibiricum, H. montanum, H. ternatum, H. pyrenaicum subsp. pollinianum, H. pyrenaicum subsp. orsinii, H. verticillatum and H. orphanidis), we previously demonstrated antimicrobial, cytotoxic (selective to cancer cells) and/or antioxidant activities. In this work, for these essential oils maximum daily intake related to total furanocoumarins (FCs) content was estimated, according to Committee on Herbal Medicinal Products of European Medicines Agency (EMA/HMPC) recommendations. FCs were quantified using gas chromatography, and their sum equivalent to xanthotoxin (8-methoxypsoralen, 8-MOP) was calculated. It was shown that daily intake, not contributing significantly to overall risk (equivalent to intake of 1.5 mg FCs) for root essential oils was in the range of 1.94-5.23 mL, for fruit oils of 5.23-15.68 mL and for leaf or flower oils of 2.90-15.68 mL. Daily intake, not posing any unacceptable risk (equivalent to intake of 15 μg FCs) for root oils was in the range of 0.02-0.05 mL, for fruit oils of 0.05-0.16 mL and for leaf or flower oils of 0.03-0.16 mL. This work demonstrates the application of current EMA/HMPC recommendations, in order to establish safety profile of herbal preparations containing FCs., Za etarska ulja korena, listova, cvasti i plodova osam taksona roda Heracleum (H. sphondylium, H. sibiricum, H. montanum, H. ternatum, H. pyrenaicum subsp. pollinianum, H. pyrenaicum subsp. orsinii, H. verticillatum i H. orphanidis) prethodno su pokazane antimikrobna, citotoksična (selektivna prema tumorskim ćelijama) i/ili antioksidantna aktivnost. Cilj ovog rada bio je da se ustanovi maksimalni dozvoljeni dnevni unos etarskih ulja u odnosu na utvrđeni sadržaj ukupnih furanokumarina, u skladu sa preporukama Komiteta za biljne lekovite proizvode Evropske agencije za lekove (EMA/HMPC). Furanokumarini su kvantifikovani gasnom hromatografijom i njihov ukupni sadržaj izražen je kao ksantotoksin (8- metoksipsoralen, 8-MOP). Dnevni unos ispitivanih etarskih ulja koji ne doprinosi značajno ukupnom riziku (ekvivalentan unosu 1,5 mg furanokumarina izraženih kao 8-MOP), kreće se u opsegu 1,94-5,23 mL za etarska ulja korena, 5,23-15,68 mL za ulja plodova i 2,90-15,68 mL za ulja listova ili cvasti. Dnevni unos etarskih ulja koji ne predstavlja nikakav rizik (ekvivalentan unosu 15 μg furanokumarina izraženih kao 8-MOP), kreće se u opsegu 0,02-0,05 mL za etarska ulja korena, 0,05-0,16 mL za ulja plodova i 0,03-0,16 mL za ulja listova ili cvasti. Ovaj rad demonstrira primenu aktuelnih EMA/HMPC preporuka u cilju utvrđivanja bezbednosnog profila biljnih preparata u kojima su detektovani furanokumarini.", publisher = "Beograd : Savez farmaceutskih udruženja Srbije", journal = "Arhiv za farmaciju", title = "Evaluation of safety profile of the essential oils of eight Heracleum taxa (Apiaceae) related to determined furanocoumarin content, Procena bezbednosnog profila etarskih ulja osam taksona roda Heracleum (Apiaceae) u odnosu na utvrđeni sadržaj furanokumarina", volume = "69", number = "3", pages = "165-175", doi = "10.5937/arhfarm1903165U" }
Ušjak, L., Drobac, M., Niketić, M.,& Petrović, S.. (2019). Evaluation of safety profile of the essential oils of eight Heracleum taxa (Apiaceae) related to determined furanocoumarin content. in Arhiv za farmaciju Beograd : Savez farmaceutskih udruženja Srbije., 69(3), 165-175. https://doi.org/10.5937/arhfarm1903165U
Ušjak L, Drobac M, Niketić M, Petrović S. Evaluation of safety profile of the essential oils of eight Heracleum taxa (Apiaceae) related to determined furanocoumarin content. in Arhiv za farmaciju. 2019;69(3):165-175. doi:10.5937/arhfarm1903165U .
Ušjak, Ljuboš, Drobac, Milica, Niketić, Marjan, Petrović, Silvana, "Evaluation of safety profile of the essential oils of eight Heracleum taxa (Apiaceae) related to determined furanocoumarin content" in Arhiv za farmaciju, 69, no. 3 (2019):165-175, https://doi.org/10.5937/arhfarm1903165U . .