28-day repeated-dose toxicity of orally administered Jinmao Jiedu granule in Sprague-Dawley rats

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2024-07, Vol.1242, p.124176, Article 124176
• Main Authors: Ren, Lijun, Peng, Hao, Mu, Hui, Li, Jinfeng, Zhou, Xibin, Zhang, Yanhong, Xuan, Qiwen, Zhang, Xiayan, Dai, Xiaoyu, Chen, Yun, Fan, Minwei, Mo, Fengfeng, Li, Bai, Yan, Lang, Zheng, Guoyin
• Format: Article
• Language: English
• Subjects: Actinidia; adjuvants; body weight; chickens; Chinese medicine preparation; chromatography; gizzard; hematology; histopathology; Jinmao Jiedu granule; liver neoplasms; necropsy; no observed adverse effect level; Oriental traditional medicine; Rat; Repeated-dose toxicity; Salvia; subchronic toxicity; therapeutics; urinalysis
• ISSN: 1570-0232; 1873-376X; 1873-376X
• DOI: 10.1016/j.jchromb.2024.124176

[Display omitted] •Jinmao Jiedu granule has been used as an adjunctive treatment for cancer, especially liver cancer.•The repeated-dose toxicity of Jinmao Jiedu granules in SD rats was evaluated for the first time.•The NOAEL of the Jinmao Jiedu granule in SD rats was higher than 11.40 g/kg/day. Jinmao Jiedu granule is a Chinese medicine preparation consisting of Actinidia valvata Dunn, Salvia chinensis Benth, Iphigenia indica Kunth, and chicken gizzard. For many years, it has been employed in adjuvant therapy for cancer, especially liver cancer. However, the potential toxicity of the granule has not been reported. The present study aimed to assess the repeated-dose toxicity of orally administered Jinmao Jiedu granules for Sprague-Dawley (SD) rats. SD rats were orally administered Jinmao Jiedu granules at doses of 2.85, 5.70, and 11.40 g/kg in a 28-day subchronic toxicity study. No adverse clinical signs associated with treatment were noted throughout the experiment. There were no treatment-related toxicity alterations in body weight, hematology, clinical biochemistry, urinalysis, necropsy, and histopathology in rats compared with the control group. The No Observed Adverse Effect Level (NOAEL) of the Jinmao Jiedu granule was higher than 11.40 g/kg/day in rats.