Toxicological testing of Fuganlin Oral Liquid on young Sprague Dawley rats

Abstract

Purpose: To further evaluate the safety of Fuganlin Oral Liquid (FGLOL) for clinical application by conducting toxicological tests in young rats. Methods: Based on the clinical dose for infants aged less than 1 year, 4-day-old Sprague-Dawley (SD) rats were orally administered FGLOL3.88, 11.64 and 38.75 g crude drug/kg for 18 days, followed by a 3-week withdrawal. This was followed by evaluating the effect of FGLOL on various growth and development indicators, nerve reflex function and spontaneous behavior of the rats. Based on the clinical dose for children aged 1 - 6 years, 15-day-old rats were orally administered FGLOL3.88, 11.64 and 38.75 g crude drug/kg for 31 days, followed by a 3-week withdrawal in order to evaluate the impact of the FGLOL on the development of reproductive organs and nervous systems in young rats. The effects of FGLOL on the safety of young rats were judged based on ophthalmic examination, physical examination, spontaneous behavior and other developmental effects. Results: FGLOL did not cause animal death, and no significant toxicological changes were observed in the body weight, growth and development, and behavior of the young rats (p < 0.05). No observed adverse effect level (NOAEL) even after administering the higher dose at each stage. However, the results at each stage showed that oral administration of a large amount of FGLOL had a greater effect on normal food consumption of the rats (p < 0.05). Conclusion: The findings indicate that Fuganlin Oral Liquid, a traditional Chinese medicine formulation, is safe in rats. However, clinical trials are required to acertain its safety in humans.