Safety and Toxicity of Qi‐Fu Yin, a Classical Traditional Chinese Medicine Prescription: A Nonclinical Research

ABSTRACT Qi‐Fu‐Yin (QFY) is a classic prescription in traditional Chinese medicine for treating dementia, such as Alzheimer's disease, but its safety has not yet been investigated. The purpose of this study was to assess the safety pharmacology and toxicology of QFY extract powder (QFYEP) to provide guidance for clinical trials or applications of QFY and its innovative formulations. The safety pharmacology of QFYEP on the central nervous system and respiratory system and its acute toxicity and 26‐week repeated‐dose toxicity were evaluated in Sprague–Dawley (SD) rats. The safety pharmacology of QFYEP on the cardiovascular system was evaluated in beagle dogs. Additionally, the genotoxicity of QFYEP was assessed using the Ames test, an in vitro chromosome aberration test, and an in vivo micronucleus test. Under the experimental doses, no effects of QFYEP on the central nervous system or respiratory system were detected, no acute toxicity, long‐term toxicity, or genotoxic effects of QFYEP were observed at any of the experimental doses. Specifically, the no‐observed adverse‐effect level (NOAEL) for the 26‐week rat toxicity study was 10 g/kg/day (approximately 42 times the intended human clinical dose). The only finding of note was dose‐related vomiting and elevated blood pressure in the dog safety pharmacology study at oral doses 5.2‐ to 10.4‐ times the proposed clinical dose. In conclusion, this safety package of studies supports development of QFYEP in the clinic but with monitoring for any cardiovascular changes.