General toxicology of Yiya Jianpi jel among juvenile animals

doi:10.19803/j.1672-8629.20220081

Abstract

Abstract: Objective To evaluate the safety of Yiya Jianpi jel and its effects on the growth of juvenile SD rats via acute toxicity and long-term toxicity tests. Methods The acute toxicity test was conducted using the maximum tolerable dose (MTD) method. The maximum dose was 5.2 g·kg-1, twice a day, and the total dose was 10.4 g·kg-1. After administration, the toxic reactions of rats were closely observed. The 200 juvenile SD rats used in the long-term toxicity test were divided into the high (3.9 g·kg-1), medium (2.6 g·kg-1), low (1.3 g·kg-1) dose groups and control group, with 50 rats in each. The drug was administered for ninety consecutive days before the rats were allowed to recover for twenty-eight days. The main indexes for examination were body mass, food intake, hematology, blood biochemistry, physiological development, endocrine, neuroethology and pathology. Results The MTD of Yiya Jianpi jel exceeded 10.4 g·kg-1 in juvenile SD rats, and no obvious side effects were observed. In the high dose group, transient changes were observed in some of the indexes during the long-term toxicity test, but no drug-related toxic pathological changes were observed (3.9 g·kg-1). Conclusion Under the conditions used in this experiment, Yiya Jianpi jel causes no obvious toxic reactions to the tested animals and clinical use in children is supported.

Key words: Yiya Jianpi jel, acute toxicity, repeated toxicity, juvenile animal, nonclinical safety evaluation, rats

CLC Number:

R975
R994.11

LIU Huan, YUAN Hui, YIN Jingjing, LIU Mengya, QIN Xiujun, LI Jianguo. General toxicology of Yiya Jianpi jel among juvenile animals[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 416-422.

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