SAFETY EVALUATION OF TIEU PHONG THANG REMEDY ON EXPERIMENTAL ANIMALS
Main Article Content
Abstract
Objectives:To determine the acute safety threshold and evaluate the sub-chronic toxicity of Tieu phong thang (TPT) remedy by assessing its effects on general condition, hematological, biochemical parameters, and histopathology of the liver and kidneys in experimental animals. Methods: Acute toxicity was investigated in Swiss mice to determine the LD50. For subchronic toxicity, 30 Wistar rats were randomly divided into 3 groups (n = 10 per group): A control group (distilled water), treatment group 1 (TPT at a dose of 17.05 g/kg/day), and treatment group 2 (TPT at a dose of 51.15 g/kg/day). Parameters were evaluated at D0, D14, and D28. Histopathology of the liver and kidneys was assessed on day 28. Results: The LD50 of TPT in Swiss mice could not be determined at the maximum oral dose (375 g/kg). In the sub-chronic study, the remedy did not alter clinical manifestations or body weight gain (p > 0.05). Hematological parameters (RBC, HGB, HCT, WBC, PLT) and biochemical parameters (AST, ALT, creatinine, albumin, total cholesterol) showed no statistically significant differences between the treatment groups and the control group (p> 0.05). No gross or microscopic lesions were recorded in the liver or kidneys. Conclusion: TPT oral solution exhibited no acute toxicity and achieved sub-chronic safety at the investigated doses.
Keywords
Tieu phong thang, Acute toxicity, Subchronic toxicity, Gout, Experimental animals
Article Details
References
2. Zhang Y et al. Natural xanthine oxidase inhibitors for gout therapy. Frontiers in Pharmacology. 2022; 13, 856331.
3. Zhang L, et al. Gnetum montanum Markgr. extracts and its main component resveratrol derivative inhibit xanthine oxidase and reduce serum uric acid in hyperuricemic mice. Journal of Ethnopharmacology. 2019; 239:111910.
4. Chen Y, et al. Anti-inflammatory mechanisms of medicinal plants used for arthritis. International Journal of Molecular Sciences. 2023; 24(3):2541
5. Bộ Y tế. Thông tư số 21/2018/TT-BYT: Quy định về việc đăng ký lưu hành thuốc cổ truyền, dược liệu, Hà Nội. 2018.
6. OECD. Test No. 407: Repeated dose 28-day oral toxicity study in rodents. OECD guidelines for the testing of chemicals, Section 4. 2008.
7. OECD. Test No. 420: Acute oral toxicity-fixed dose procedure. OECD Publishing. 2001.
8. World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Geneva. 2004.
9. Nguyễn Trọng Hiệp, Vũ Quân và CS. Đánh giá độc tính bán trường diễn của viên nang cứng điều trị xương khớp trên động vật thực nghiệm. Tạp chí Y Dược học Quân sự. 2022; 7:15-22.
10. Bộ Y tế. Dược điển Việt Nam V. Nhà xuất bản Y học. Hà Nội. 2018.