Toxicity study of oral administration of Shufeng Jiedu Capsule for 14 d in SD rats during peri-weaning period
10.7501/j.issn.0253-2670.2018.09.022
- Author:
He-Ming FU
1
Author Information
1. Tianjin Institute of Pharmaceutical Research Drug Assessment Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Neonatal SD rats;
RBC;
Repeated dose toxicity;
Ret;
Safety evaluation;
Shufeng Jiedu Capsule
- From:
Chinese Traditional and Herbal Drugs
2018;49(9):2119-2126
- CountryChina
- Language:Chinese
-
Abstract:
Objective To characterize the oral toxicity of Shufeng Jiedu Capsule (SFJD) in SD rats during peri-weaning period, and provide reference for the clinical application of SFJD in infants. Methods Ten-day-old healthy SD rats were exposed to 0 and 4 g/kg of SFJD once per day for 14 d via intra-gastric administration. Mortality, general physical signs, body weights, spontaneous motor activity, learning and memory functions, hematology (with T and B lymphocyte subgroups included), serum chemistry, serum testosterone, insulin-like growth factor, organ weights, as well as gross pathological findings were evaluated between the control and exposure group. Physical development indicators such as pinna unfolding, coat growth, incisor eruption, and eyes opening time, were also recorded. The body length and tail length of rats under anesthesia were detected. Results After SFJD administration, loose stools and orange colored urine were found in rats, and the color of the urine was related to the color of drugs. The body weight growth rates were decreased compared with the control group. Urine specific gravity was increased in rats. RBC and Ret concentrations were decreased in two of the 16 tested animals. Liver, spleen, and kidney ratios to body and brain weight were increased in rats; The weight of spleen was also increased compared with the control group. Conclusion It was well tolerated to peri-weaning rats after the ig administration of 4 g/kg SFJD. The concerns of diarrhea, mild body weight growth rate, as well as RBC and Ret decrease should be noted for long term and high dose usage in infants and toddlers.
