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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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2019
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Authors
Ušjak, Ljuboš
Drobac, Milica
Niketić, Marjan
Petrović, Silvana
Article (Published version)
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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 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.

Keywords:
Heracleum / essential oils / furanocoumarins / 8-MOP / safety profile
Source:
Arhiv za farmaciju, 2019, 69, 3, 165-175
Publisher:
  • Beograd : Savez farmaceutskih udruženja Srbije
Funding / projects:
  • Investigation on the medicinal plants: morphological, chemical and pharmacological characterisation (RS-173021)

DOI: 10.5937/arhfarm1903165U

ISSN: 0004-1963

Scopus: 2-s2.0-85080913865
[ Google Scholar ]
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3474
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - 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 . .

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