动力源胶囊的安全性评价研究

目的对抗运动疲劳功能食品动力源胶囊进行安全性评价研究。方法采用限量法测定急性毒性试验,给予KM小鼠受试物最大剂量1 0 g/kg·BW后,观察14天内有无动物死亡,计算半数致死量(LD50)。应用30 d喂养试验观察可能的亚慢性毒性,分别设2670 mg/kg·BW、1330 mg/kg·BW、670 mg/kg·BW)剂量组和蒸馏水空白对照组,灌胃给予SD大鼠受试物30 d,观察和记录SD大鼠的生长发育情况、摄食量、食物利用率、血液学指标、血液生化指标和脏器病理检查。结果急性毒性试验观察期内受试动物未出现任何异常表现及死亡,表明样品无毒;在30 d喂养试验中各组大鼠给予不同剂量的动力源胶囊30 d后,其血液生化学检查、脏器称量结果表明,各检验项目的实验组与对照组比较均差异不显著。病理组织学检查结果表明对照组和各剂量组雄、雌性大鼠的肝、脾、肾、胃、肠、睾丸(卵巢)均未见与实验因素有关的病理组织学变化,表明30 d喂养试验未见其对受试动物有毒性损害作用。结论动力源胶囊使用安全。

Safety evaluation on Dongliyuan capsule

Objective To evaluate the safety of anti fatigue functional food of Dongliyuan capsule by toxicology study. Methods The acute toxicity tests were determined by limit method, KM mice were given the maximum dose of 10 g/kg?BW and observed the death within 14 days, and the median lethal dose (LD50) were calculated. SD rats 30 days feeding test: 2670 mg/kg?BW, 1330 mg/kg?BW, 670 mg/kg?BW dose group were administrated for 30 days by intragastric respectively and distilled water as control group, then the growth of SD rats and the perturbation of appetite, food utilization rate, blood serum, blood biochemical indexes and pathological examinations were observed and recorded. Results During the observation period of acute toxicity test, there was no abnormal expression and death of the tested animals, so the samples showed no toxicity. After 30 d feeding test, the blood chemical examination, body weighting results showed that the difference of each test item of experiment group and control group was not significant. Histopathological examination showed that the liver, spleen, kidney, stomach, intestine and testis (ovary) of the control group and the high dose group were not related to the pathological changes of the experimental factors, so 30 days feeding test showed no toxicity to the tested animals. Conclusion Dongliyuan capsule is safety for use by the safety evaluation study.