21. Acute and sub-chronic toxicity of capsule extracted from Da day HD herbal formular in experimental animals

Nghiem Thi Thanh Huong, Nguyen Thi Thanh Tu

Main Article Content

Abstract

This study aimed to evaluate the acute and sub-chronic toxicity of capsule extracted from Da Day HD herbal formular in the experimental animals. The acute toxicity was performed based on the Litchfield - Wilcoxon method. The sub-chronic toxicity was evaluated according to the World Health Organization's guidance. The results showed that the highest dose of capsule extracted from Da Day HD herbal formular (45.0 g/kg b.w./day, 51 times as high as the maximal recommended human dose) did not show acute oral toxicity in mice and the median lethal dose (LD50) was not determined. Administration of capsule extracted from Da Day HD herbal formular at 0.48 g/kg b.w./day (equivalent to clinical dose) and 1.44 g/kg body weight (three times as high as the clinical dose) in 12 consecutive weeks did not produce any significant detrimental effect on the body weight, hematological and biochemical parameters, as well as the gross and microscopic images of the rats’ liver and kidney, compared to control group (p > 0.05).

Article Details

References

1. Abbasi-Kangevari M, Ahmadi N, Fattahi N, et al. Quality of care of peptic ulcer disease worldwide: A systematic analysis for the global burden of disease study 1990 - 2019. PLoS ONE. 2022;17(8). doi:10.1371/journal.pone.02 71284
2. Hooi JKY, Lai WY, Ng WK, et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta - Analysis. Gastroenterology. 2017;153(2):420-429. doi:10 .1053/j.gastro.2017.04.022
3. Quach DT, Mai BH, Tran MK, et al. Vietnam Association of Gastroenterology (VNAGE) consensus on the management of Helicobacter pylori infection. Front Med. 2023;9:1065045. doi:10.3389/fmed.2022.1065045
4. Nguyen TL, Uchida T, Tsukamoto Y, et al. Helicobacter pylori infection and gastroduodenal diseases in Vietnam: a cross-sectional, hospital-based study. BMC Gastroenterol. 2010;10:114. doi:10.1186/1471-230X-10-114
5. Sverdén E, Agréus L, Dunn JM, et al. Peptic ulcer disease. BMJ. Published online October 2, 2019:l5495. doi:10.1136/bmj.l5495
6. Trần Phương Thủy. Đánh giá độc tính và tác dụng điều trị của viên “Dạ dày HĐ” trên bệnh nhân viêm dạ dày mạn tính Helicobacter Pylori âm tính. Published online 2019.
7. Tú NTT, Huệ PT. Tác dụng của viên hoàn cứng “dạ dày HĐ” trong điều trị loét dạ dày tá tràng có helicobacter pylori âm tính. J Clin Med- Hue Cent Hosp. 2023;(85). doi:10.38103/jcmhch.85.11
8. Litchfield J T, Wilcoxon F A. A simplified method of evaluating dose-effect experiments. J. Pharmacol. Exp. Ther. 1949;96:99-113.
9. Bộ Y tế. Quyết định 141/QĐ-K2ĐT 2015 Hướng dẫn thử nghiệm tiền lâm sàng lâm sàng thuốc đông y. Cục Khoa học Công nghệ và Đào tạo. Accessed November 26, 2023. https://t huvienphapluat.vn/van-ban/The-thao-Y-te/Q uyet-dinh-141-QD-K2DT-2015-Huong-dan-thu-nghiem-tien-lam-sang-lam-sang-thuoc-dongy- 414589.aspx
10. WHO. Research guidelines for evaluating the safety and efficacy of herbal medicines. Accessed September 29, 2022. https://www.who.int/publications-detail-redirect/ 9290611103
11. Chiến NA. Đánh giá tác dụng của viên “Dạ dày HĐ” trên bệnh nhân trào ngược dạ dày- thực quản. Luận văn Thạc sỹ y học. Trường Đại học Y Hà Nội; 2020. Accessed November 26, 2023. http://dulieuso.hmu.edu.vn/handle/hmu/9 47
12. Dược Điển Việt Nam. Chè dây (lá). Published July 30, 2018. Accessed November 27, 2023. https://duocdienvietnam.com/che-da y-la/
13. OECD. OECD guidelines for the testing of chemicals - Repeated Dose 28-Day Oral Toxicity Study in Rodents. Accessed November 27, 2023. https://ntp.niehs.nih.gov/sites/defaul t/files/iccvam/suppdocs/feddocs/oecd/oecdtg4 07-2008.pdf
14. WHO. Working group on the safety and efficacy of herbal medicine. Rep Reg Off West Pac World Health Organ. Published online 2000.