Dermal toxicity, dermal irritation, and delayed contact sensitization evaluation of oil body linked oleosin-hEGF microgel emulsion via transdermal drug delivery for wound healing.
Cutan Ocul Toxicol
; 40(1): 45-53, 2021 Mar.
Article
em En
| MEDLINE
| ID: mdl-33438439
ABSTRACT
Objective:
The expression of therapeutic proteins in plant oil body bioreactors has attracted much attention. But its safety is not yet clear. This article determines the risk of safety after using the drug.Methods:
The oil body-linked oleosin-hEGF microgel emulsion (OBEME) was prepared by mixing the xanthan gum with suitable concentrations in an appropriate proportion. Skin irritation and sensitization reaction were investigated in rats and guinea pigs using OBEME as test article.Results:
The OBEME did not produce dermal erythema/eschar or oedema responses. The dermal subacute and subchronic toxicity of OBEME were evaluated in accordance with OECD guidelines. Compared with the control group, the basic physical signs, such as weight, feed, drinking, excretion, and behaviour of experimental animals, were not abnormal. In addition, no abnormality was found in haematological parameters, biochemical indexes, relative organ weight, and histopathological observation of organs, and there was no significant difference compared with normal saline treatment group. Therefore, we conclude that OBEME has no toxic effects and is safe and reliable to be used for topical application.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Proteínas de Plantas
/
Pele
/
Proteínas Recombinantes de Fusão
/
Portadores de Fármacos
/
Fator de Crescimento Epidérmico
Tipo de estudo:
Diagnostic_studies
/
Etiology_studies
/
Guideline
Idioma:
En
Revista:
Cutan Ocul Toxicol
Assunto da revista:
DERMATOLOGIA
/
OFTALMOLOGIA
/
TOXICOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article