Oral toxicity and genotoxicity assessment of standardized Echinacea purpurea (L.) extract and the pharmacokinetic profile of its active ingredient chicoric acid

Echinacea purpurea (L.), a member of Asteraceae family, has traditionally been used in numerous countries to treat and prevent various immune-related diseases. This study confirmed the oral toxicity and genotoxicity profile of standardized E. purpurea extract under good laboratory practice (GLP) conditions and the pharmacokinetic features of chicoric acid, a major ingredient in E. purpurea extract. For the repeated-dose toxicity test, Sprague Dawley (SD) rats were orally administered 500, 1000, and 2000 mg/kg/day of E. purpurea extract continuously for 13 weeks. The genotoxicity of E. purpurea was determined using standard genotoxicity tests, including bacterial reverse mutations, chromosome aberrations, and micronucleus tests. Additionally, a validated LC–MS/MS method was employed to measure chicoric acid levels in rat plasma for pharmacokinetic analysis. The results of this study indicate that during repeated oral administration of E. purpurea, both male and female SD rats showed no abnormal clinical signs. Furthermore, the genotoxicity tests did not reveal any evidence of genotoxicity in E. purpurea. Pharmacokinetic profile of chicoric acid, following the oral administration of highly purified chicoric acid (95