Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Toxicological testing of Fuganlin Oral Liquid on young Sprague-Dawley rats

Jianmin Guo^1-3, Yuankeng Huang^1,3, Xialing Lei^1,3, Yinghua Deng¹, Xiaoying Li¹, Wenqiang Zhang¹, Wenpei Chen^1,3, Feibiao Meng¹, Wei Yang^1-3

¹Guangdong Lewwin Pharmaceutical Research Institute Co. Ltd, Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research, TCM Non-clinic Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine, Guangdong Engineering Research Center for Innovative Drug Evaluation and Research, Guangzhou, China; ²Guangdong Key Laboratory of Animal Conservation and Resource Utilization, Guangdong Public Laboratory of Wild Animal Conservation and Utilization, Institute of Zoology, Guangdong Academy of Sciences, Guangzhou, China; ³Guangzhou Huabo Biopharmaceutical Research Institute, Guangzhou, China.

For correspondence:- Wei Yang Email: ywdoccn@163.com Tel:+8618928860179

Accepted: 14 December 2022 Published: 30 January 2023

Citation: Guo J, Huang Y, Lei X, Deng Y, Li X, Zhang W, et al. Toxicological testing of Fuganlin Oral Liquid on young Sprague-Dawley rats. Trop J Pharm Res 2023; 22(1):105-112 doi: 10.4314/tjpr.v22i1.15

© 2023 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

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.

Keywords: Fuganlin Oral Liquid, Safety, Acute toxicity, Developmental toxicity, Juvenile rats