Acute and Sub-Chronic Toxicity of “Kien Vi Bo Trung HD” Hard Capsule in Experimental Models
Main Article Content
Abstract
This study aimed to evaluate the acute and sub-chronic toxicity of the “Kien Vi Bo Trung HD” hard capsule in experimental models. The acute oral toxicity was assessed in Swiss mice, while the sub-chronic toxicity was evaluated in Wistar rats in accordance with the World Health Organization (WHO) guidelines. The results demonstrated that administration of the highest dose (25 g/kg body weight - equivalent to 34.7 times the anticipated clinical dose) did not result in any mortality, and thus the median lethal dose (LD50) of the capsule could not be determined. The “Kien Vi Bo Trung HD” hard capsule did not induce sub-chronic toxicity in Wistar rats when administered orally at a clinical equivalent dose (0.36 g/kg body weight/day) and at a three times higher dose (1.08 g/kg body weight/day) for 90 consecutive days. All monitored parameters, including general clinical observations, body weight, hematopoietic function, liver and kidney function, remained within normal limits. Histopathological examinations of hepatic and renal tissues of the study groups revealed no significant difference compared to the control group (p > 0.05).
Article Details
Keywords
Acute toxicity, Sub-chronic toxicity, “Kien Vi Bo Trung HD” hard capsule
References
2. Nguyễn Thị Vân Hồng. Bệnh học nội khoa tập 2. Nhà Xuất Bản Y Học; 2020:106-111.
3. Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021; 160(1): 99-114.e3. doi:10.1053/j.gastro.2020.04.014.
4. Goodoory VC, Ng CE, Black CJ, Ford AC. Direct healthcare costs of Rome IV or Rome III-defined irritable bowel syndrome in the United Kingdom. Aliment Pharmacol Ther. 2022; 56(1): 110-120. doi:10.1111/apt.16939.
5. Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2012; 10(7): 712-721.e4. doi:10.1016/j.cgh.2012.02.029.
6. Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020; 5(10): 908-917. doi:10.1016/S2468-1253(20)30217-X.
7. Black CJ, Ford AC. Global burden of irritable bowel syndrome: trends, predictions and risk factors. Nat Rev Gastroenterol Hepatol. 2020; 17(8): 473-486. doi:10.1038/s41575-020-0286-8.
8. Nguyễn Thúy Bích, Phan Trung Nam. Tỷ lệ mắc và một số yếu tố liên quan hội chứng ruột kích thích ở sinh viên y khoa trường Đại học Y dược, Đại học Huế. Tạp Chí Dược Học. 2020; 10(5): 11.
9. Đỗ Thị Phương, Trịnh Duy Công. Tác dụng viên hoàn cứng “Kiện vị bổ trung” trong điều trị hội chứng ruột kích thích thể lỏng. Tạp chí Y Dược cổ truyền Việt Nam. 2023; 47(1): 30-34. doi:10.60117/vjmap.v47i1.7.
10. Thông tư 29/2018/TT-BYT Quy định về thử thuốc trên lâm sàng. Published online October 29, 2018.
11. Gerhard H. Vogel. Drug Discovery and Evaluation: Pharmacological Assays. Springer; 2016;1-5.
12. Cục khoa học công nghệ và đào tạo. Quyết định số 141/QĐ-K2ĐT về việc ban hành tài liệu chuyên môn “Hướng dẫn thử nghiệm tiền lâm sàng và lâm sàng thuốc đông y, thuốc từ dược liệu.” Published online October 27, 2015.
13. WHO. Working group on the safety and efficacy of herbal medicine, Report of regional office for the western pacific of the World Health Organization. Published online 2000.
14. Research guidelines for evaluating the safety and efficacy of herbal medicines. Accessed September 29, 2022. https://www.who.int/publications-detail-redirect/9290611103.
15. OECD Test Guidelines 407-2008.pdf. Accessed November 27, 2023. https://ntp.niehs.nih.gov/sites/default/files/iccvam/suppdocs/feddocs/oecd/oecdtg407-2008.pdf.
16. Organization WH. Working group on the safety and efficacy of herbal medicine. Rep Reg Off West Pac World Health Organ. Published online 2000.