4. Evaluation of acute and subchronic toxicities of BTL lozenges on experimental animals

Vu Nam, Pham Ngoc Yen Mi, Pham Thi Van Anh, Duong Trong Nghia, Nguyen Tuong Linh, Tran Thanh Tung

Nội dung chính của bài viết

Tóm tắt

ThIs research evaluated the acute and subchronic toxicities of BTL lozenges through oral administration in experimental animals. The acute toxicity was determined by Litchfield Wilcoxon method in Swiss mice. The subchronic toxicity was evaluated by the recommendation of WHO and OECD in Wistar rats with oral doses of 720 g/kg body weight/day (equal to recommended human dose) and 1440 g/kg body weight/day (2 times as high as recommended human dose) in 90 consecutive days. As a result, BTL lozenges at the highest dose used for mice (12 lozenges/kg body weight) did not express acute toxicity in mice. In terms of the subchronic toxicity test, after oral administration of BTL lozenges, hematological parameters, hepato-renal functions and microscopic images of liver and kidney at an equivalent to the human recommended dose were unchanged as compared with the control group. In conclusion, BTL lozenges with both doses 720 g/kg body weight/day and 1440 g/kg body weight/day did not produce acute and subchronic toxicities in Swiss mice and Wistar rats.

Chi tiết bài viết

Tài liệu tham khảo

1. Ogbonnia S, Adekunle AA, Bosa MK, et al. Evaluation of acute and subacute toxicity of Alstonia congensis Engler (Apocynaceae) bark and Xylopia aethiopica (Dunal) A. Rich (Annonaceae) fruits mixtures used in the treatment of diabetes. Afr J Biotechnol. 2008; 7(6). doi:10.4314/ajb.v7i6.58507.
2. World Health Organization. WHO Global Report on Traditionnal and Complementary Medicin. World Health Organization; 2010. Accessed September 14, 2021. https://apps.who.int/iris/handle/10665/340838.
3. Alhaji Saganuwan S. Toxicity studies of drugs and chemicals in animals: An overview. Bulg J Vet Med. 2017; 20: 291-318. doi:10.15547/bjvm.983.
4. Jong WH, Carraway J, Re G. In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices. Biocompat Perform Med Devices. Published online October 1, 2012: 120-158. doi:10.1016/B978-0-85709-070-6.50007-9.
5. Zhao YL, Su M, Shang JH, et al. Acute and Chronic Toxicity of Indole Alkaloids from Leaves of Alstonia scholaris (L.) R. Br. in Mice and Rats. Nat Prod Bioprospecting. 2020; 10(2): 77-88. doi:10.1007/s13659-020-00237-1.
6. Ha TT, Thao BTP. Study the efficiency of smoking cessation through the blt tea and medical advice. Vietnam Med J. 2021; 509(2): 50-54.
7. Ha VTT. Research on Experimental Safety of CTL Tablets and Clinical Effects Combined with Counseling in the Treatment of Tobacco Addiction. Thesis of Master of Medicine. Hanoi Medical University; 2018.
8. OECD. Guidance Document on Acute Oral Toxicity Testing. OECD; 2002. doi:10.1787/9789264078413-en.
9. World Health Organization. WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues. Published online 2007: 105.
10. Litchfield JT, Wilcoxon F. A Simplified Method of Evaluating Dose-Effect Experiments. J Pharmacol Exp Ther. 1949; 96(2): 99-113.
11. Saad B, Azaizeh H, Abu-Hijleh G, et al. Safety of traditional arab herbal medicine. Evid-Based Complement Altern Med ECAM. 2006;3(4):433-439. doi:10.1093/ecam/nel058
12. Ernst E. Toxic heavy metals and undeclared drugs in Asian herbal medicines. Trends Pharmacol Sci. 2002; 23(3): 136-139. doi:10.1016/S0165-6147(00)01972-6.
13. Cosyns JP. Aristolochic acid and “Chinese herbs nephropathy”: a review of the evidence to date. Drug Saf. 2003; 26(1): 33-48. doi:10.2165/00002018-200326010-00004.
14. Sk R. Preclinical safety assessment: current gaps, challenges, and approaches in identifying translatable biomarkers of drug-induced liver injury. Clin Lab Med. 2011; 31(1). doi:10.1016/j.cll.2010.10.004.
15. Ozer J, Ratner M, Shaw M, et al. The current state of serum biomarkers of hepatotoxicity. Toxicology. 2008; 245(3): 194-205. doi:10.1016/j.tox.2007.11.021.