Acute Toxicity of Shizaotang in Rats / 中国实验方剂学杂志

ABSTRACT

Objective:To study the acute toxicity of Shizaotang in rats, in order to provide reference for clinical drug safety and subsequent toxicological efficacy experiments. Method:Totally 40 SPF SD rats were randomly divided into control group and Shizaotang group, with 20 rats in each group (10 males and 10 females). By the maximum dose method, the Shizaotang group was given the maximum concentration of Shizaotang suspension 0.3 g·mL-1 for 2 consecutive times in the maximum dosage volume within 24 h, and the control group was given normal saline. The toxicity (death, poisoning symptoms) and its severity and recovery of the rats were observed within 14 days, and the changes in body weight and feeding before and after administration were recorded. After 14 days, the rats were put to death, and serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea nitrogen (BUN), creatinine (SCr), and interleukin-2 (IL-2), tumor necrosis factor-alpha (TNF-α) and nuclear factor-κB (NF-κB) levels were measured, each tissue was weighed, and organ coefficients were calculated. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of various organs, and evaluate the acute toxicity. Result:No animal death, obvious poisoning symptom, and visible organ abnormality were observed. Compared with the control group, there was no significant change in body weight and food consumption in the drug-administered group. There was no significant difference in the organ coefficients of rats. Serum ALT, AST, BUN, SCr, IL-2, TNF-α, and NF-κB did not change significantly, and no abnormality was observed in pathological sections of each tissue. Conclusion:The maximum oral dosage of Shizaotang in rats is 12 g·kg-1, which is 480 times of daily dosage for adults, with a good safety. This suggests that Shizaotang has a certain safety range.