Toxicology of a Peruvian botanical remedy to support healthy liver function.
J Complement Integr Med
; 13(2): 163-73, 2016 Jun 01.
Article
em En
| MEDLINE
| ID: mdl-27101557
BACKGROUND: The purpose of these studies was to determine the safety of a botanical treatment for supporting healthy liver function developed in Peru. The formulation, A4+, contains extracts of Curcuma longa L. rhizome (A4R), Cordia lutea Lam. flower (A4F) and Annona muricata L. leaf (A4L). The tests were used to support an application for a non-traditional Natural Health Product Licence from the Natural Health Product Directorate of Health Canada and future clinical trials. METHODS: Besides reviewing the scientific and clinical information from Peru on the ingredients and conducting an initial Ames test for mutagenicity, we analysed A4+ for its chemical profile and tested genotoxicity (micronucleus test) and general toxicity (28-day repeated dose). RESULTS: A4+ and extracts from the three plants provided distinctive chemical fingerprints. A4L contained acetogenins, requiring a second chromatographic method to produce a specific fingerprint. The Ames test proved positive at the highest concentration (5,000âµg/mL) but A4+ showed no evidence of genotoxicity in the more specific mouse micronucleus test. The 28-day repeated dose (general toxicity) study in rats showed no toxicity at 2,000âmg/kg. CONCLUSIONS: We conclude that under the conditions of these studies, A4+ shows no evidence of toxicity at the levels indicated. A no observed adverse effect level (NOAEL) of 2,000âmg/kg was assigned.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Extratos Vegetais
/
Curcuma
/
Annona
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Cordia
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Fígado
Limite:
Animals
País/Região como assunto:
America do sul
/
Peru
Idioma:
En
Revista:
J Complement Integr Med
Ano de publicação:
2016
Tipo de documento:
Article
País de publicação:
Alemanha