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[摘要]
目的 对苏苏小儿止咳颗粒进行幼龄SD大鼠长期毒性试验研究,为其提供临床前安全性评价。方法 苏苏小儿止咳颗粒高、中、低剂量(以生药计30、15、5 g/kg)连续ig给药30 d。观察指标包括一般观察、体质量、摄食量、行为学测试、雌二醇、睾酮、胫骨长度、尿液、血液学、凝血指标、血液生化、电解质、脏器质量、脏器系数及组织病理学检查等。结果 30 g/kg剂量组雄鼠给药期间出现体质量增长缓慢,恢复期可恢复正常。其余动物未见明显药物相关毒性反应,停药后未见迟缓毒性发生。结论 在本试验条件下,苏苏小儿止咳颗粒对幼龄大鼠的无毒反应剂量为15 g/kg,相当于临床拟用剂量的22倍。
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[Abstract]
Objective Preclinical safety study was conducted to assess the long-term toxicity effects of Susu Xiao'er Zhike (SSXEZK) Granules in juvenile rats, and provide preclinical safety evaluation for clinic. Methods Daily ig administration of SSXEZK Granules at 30, 15, and 5 g/kg for 30 d was used in high, medium, and low dose groups, respectively. The long-term toxicity effects of SSXEZK Granules was determined by general observation of the animals, and monitoring the changes of their body weight, food intake, behavioral test, estradiol, testosterone, tibial length,urine, faeces, hematology, blood coagulation, blood biochemistry, electrolyte, organ weight and organ index. Histopathological examination was conducted after sacrifice. Results All animals had no significant toxicity and no delayed toxicity occurred after treatment with various doses, except that the body weight growth of male rats was retarded treated with 30 g/kg dose. Conclusion In the situation of this experiment, the NOAEL of SSXEZK Granules in rats was 15 g/kg, which was equivalent to 22 times of the suggested dose in clinical use.
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