疏风解毒胶囊口服给药14 d对幼鼠的毒性作用研究

Toxicity study of oral administration of Shufeng Jiedu Capsule for 14 d in SD rats during peri-weaning period

目的观察10日龄健康SD大鼠重复ig给予疏风解毒胶囊(SFJD)后所产生的毒性反应,为SFJD的婴幼儿临床应用提供参考。方法取10日龄健康SD大鼠30只,分为SFJD组(4 g/kg)和对照组,每天给药1次,连续14 d。每天观察动物的死亡率及一般体征,每周2次监测动物体质量变化,观察门齿萌出、张耳、睁眼和腹部出毛的发生时间,考察幼鼠的自主活动及学习记忆能力;在给药结束时进行血液学、血清生化检测及血清睾酮、雌二醇、胰岛素样生长因子含量测定,分析T、B淋巴细胞亚群的变化;并进行系统尸检、脏器质量及系数检查,测定幼鼠麻醉状态下的体长和尾长。结果给药后幼鼠出现稀便及药物颜色相关的橙色尿液;体质量增长前期减缓,后期改善;尿密度略增加;脾脏质量及肝脏、脾脏、肾脏的脏体系数与脏脑系数增加;有2只幼鼠红细胞计数(RBC)和网织红细胞数(Ret)较对照组显著降低。结论 4 g/kg的SFJD ig给药后,幼鼠耐受性较好,临床大剂量长期应用时需关注可能出现的稀便及RBC、Ret降低等情况。

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.