Toxicological safety evaluation in acute and 28-day studies of aqueous extract from Bei-Qi-Wu-Jia formula.

Affiliation

School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, 450001, PR China; Key Laboratory of Technology of Drug Preparation (Zhengzhou University), Ministry of Education of China, Zhengzhou, 450001, PR China; Key Laboratory of Henan Province for Drug Quality and Evaluation, Zhengzhou, 450001, PR China. Electronic address: [Email]

Abstract

BACKGROUND : Bei Qi Wu Jia (BQWJ), a modern preparation of a traditional Chinese medicinal formula, is a combination of Radix Astragali and Acanthopanacis Senticosi. Although BQWJ has been used to treat insomnia, fatigue, and loss of appetite, toxicological safety studies are rare in the literature.
OBJECTIVE : To evaluate the acute and subacute toxicity of BQWJ extract after oral administration in mice and rats, respectively.
METHODS : In the acute toxicity study, mice underwent oral administration of 67.5 g extract/kg/day. In the subacute toxicity study, rats underwent a single oral administration of 1.25, 2.5, 5.0, or 10.0 g/kg/day of BQWJ extract for 28 days. The animals' general behavior, body weight, food intake, biochemical and hematologic parameters, organ coefficients, and pathological morphology were analyzed.
RESULTS : No evidence of toxicity was observed in the mice after acute exposure to BQWJ extract. The subacute results included no deaths and no changes in general behavior. Although BQWJ extract resulted in some significant changes in other parameters, these alterations cannot be considered treatment-related because they remained within normal ranges throughout the 28 days.
CONCLUSIONS : In conclusion, the oral administration of BQWJ extract at doses of less than 67.5 g/kg/day for 1 day or 10.0 g/kg/day for 28 consecutive days can be considered safe and showed no distinct toxicity or side effects in this study.

Keywords

Acanthopanax senticosus,Acute toxicity,Bei Qi Wu Jia extract,Radix astragali,Safety evaluation,Subacute toxicity,

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