Safety assessment of Wuzhuyu decoction extract: acute and subacute oral toxicity studies in rats

Abstract

Wuzhuyu decoction (WZYD) is a well-known classic traditional Chinese medicine prescription and has been widely used to treat headache, nausea, vomiting, insomnia, etc. However, little published information is available about its safety. Our aim was to investigate the acute and subacute oral toxicity of WZYD extract in rats following the technical guidelines from China’s National Medical Products Administration (NMPA) for single and repeated doses toxicity studies of drugs. Acute oral toxicity was assessed in rats via oral administration of WZYD extract at 4 g/kg three times within a day followed by a 14-day observation period. To evaluate the subacute toxicity, rats were orally administered with WZYD extract at doses of 0, 0.44, 1.33, and 4 g/kg for 28 days. The items examined included clinical signs, body weight, food consumption, hematological and biochemical parameters, bone marrow smear, organ index, and histopathology. After the rats were administered with 12 g/kg (3 × 4 g/kg) WZYD extract, no mortality and toxic effects were observed during the observation period. In the subacute toxicity study, WZYD extract did not cause any significant treatment-related abnormality in each examined item of rats, so the no observed adverse effect level (NOAEL) of WZYD extract for 28 days orally administered to rats is considered to be 4 g/kg, which is approximately 80-fold of its clinical proposed dosage.

Keywords:

• Wuzhuyu decoction
• preclinical study
• classical prescription
• rodent
• toxicological evaluation

Acknowledgements

The authors would like to thank all technicians who conducted the studies.

Author contributions

Xiaobo Li carried out the data analysis and wrote the manuscript. Yongtian Yuan, Yueming Yuan, and Xiaobo Li performed the toxicity studies in animals. Li Ru and Zheng Yuan were responsible for quality assurance of the studies. Qin Xu and Zhiyong Xu guided the project.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

All data generated or analyzed during this study are included in this published article, further inquiries can be directed to the corresponding authors.

Additional information

Funding

The work was support by the Natural Science Foundation of China (Grant Number 82074301), the China Postdoctoral Science Foundation (2023M730808), and the Science and Technology Project of Guangzhou (Grant Number 202206010066).