Permitted daily exposure from preclinical studies of Ginkgo biloba L. dry extract
Braz. J. Pharm. Sci. (Online)
; 59: e23037, 2023. tab, graf
Article
in English
| LILACS
| ID: biblio-1520322
Responsible library:
BR40.1
Localization: BR40.1
ABSTRACT
Abstract Resolution 658/2022 of the Brazilian Regulatory Agency requires the determination of the permitted daily exposure (PDE) of pharmaceutical agents. Ginkgo biloba L. is used therapeutically to treat memory deficits and other brain diseases. However, published results indicate that more studies are needed to confirm the safety of Ginkgo biloba. This study aimed to evaluate the dry extract of Ginkgo biloba L. leaves PDE as an ingredient in an oral pharmaceutical product in preclinical studies using mice. Acute oral toxicity and repeated dose experiments were performed based on OECD guidelines, as well as genotoxicity tests. The results indicate that Ginkgo biloba L. has low acute toxicity, no liver toxicity, and does not alter blood glucose levels. No changes in weight gain were observed, but food intake decreased in males during the first week of treatment at the highest dose. Hematological parameters were not altered in males, whereas females presented lower leukocyte and lymphocyte counts and higher neutrophil counts at the highest dose. The lipid profile was not altered in males, whereas total cholesterol was increased in females. The estimated PDE was 0.1 mg/day and, when related to the maximum residual concentration, indicates that the cleaning process used is safe and does not require reassessment.
Full text:
Available
Collection:
International databases
Database:
LILACS
Main subject:
Plant Extracts
/
Genotoxicity
/
Ginkgo Extract
Limits:
Animals
Language:
English
Journal:
Braz. J. Pharm. Sci. (Online)
Journal subject:
Farmacologia
/
Teraputica
/
Toxicologia
Year:
2023
Document type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
FEEVALE University/BR
/
Lutheran University of Brazil/BR
/
University of Vale do Rio dos Sinos/BR