蒙兽药巴特尔-7的急性和亚慢性毒理学研究

Acute and sub-chronic toxicological study of Mongolian medicine Baatar-7

试验研究蒙兽药巴特尔-7(Baatar-7)的急性毒性和亚慢性毒性。选取60只健康SPF级昆明小鼠,随机分为6组,对照组(灌服0.2 mL/10 g·BW生理盐水)和Baatar-7剂量1~5组(分别按5000.0、2500.0、1250.0、625.0和312.5 mg/kg·BW 1次性灌服Baatar-7药液),连续观察7 d,记录小鼠中毒和死亡情况。取20只小鼠,随机分为2组,对照组(灌服0.2 mL/10 g·BW生理盐水)和Baatar-7组(灌服5000 mg/kg·BW Baatar-7药液,0.2 mL/10 g·BW),每组10只小鼠(雌、雄各半),24 h给药2次(8:00、16:00),饲养7 d,观察记录其中毒症状、死亡时间及数量,并观察小鼠有无肉眼可见病变。取40只健康SPF级Wistar大鼠,随机分为4组,对照组(2 mL/100 g·BW灌服生理盐水)和Baatar-7低剂量组(Baatar7-L组)、中剂量组(Baatar7-M组)、高剂量组(Baatar7-H组)(分别给予2.5、5.0、10.0 g/kg·BW的Baatar-7药液),每组10只大鼠(雌、雄各半),1次/d,连续6 w,1次/w称重。采血进行血常规和血液生化学检查,计算脏器指数并进行组织病理学观察。结果显示,急性毒性试验各剂量组小鼠均未出现死亡情况,无法得出该复方LD50。小鼠对Baatar-7的最大耐受量为10000 mg/kg·BW,说明Baatar-7安全无急性毒性。亚慢性毒性试验中,各给药组大鼠体重、血常规、血液生化指标以及脏器指数与对照组无显著差异(P>0.05),剖检和组织学观察未见明显异常变化,说明Baatar-7安全无亚慢性毒性。试验表明,Baatar-7在本试验计量范围内属于安全无毒。

The experimental studied the acute and sub-chronic toxicity of Mongolian medicine Baatar-7.60 healthy SPF Kunming mice were divided into six groups,namely the control group(infused with 0.2 mL/10 g·BW normal saline)and Baatar-7 groups 1~5(infusions of Baatar-7 liquid at 5000.0,2500.0,1250.0,625.0 and 312.5 mg/kg·BW,respectively).Observe continuously for 7 d.Record the poisoning and death of mice.20 Kunming mice were randomly divided into two groups,namely the control group(0.2 mL/10 g·BW normal saline)and Baatar-7 group(5000 mg/kg·BW Baatar-7 liquid by gavage),each group of 10 mice(male and female half),two times in 24 h(8:00,16:00).Mice were normally fed for 7 d.We observe and record the poisoning symptoms,death time and number of the mice,and observe whether the mice have visible lesions.40 healthy SPF Wistar rats were randomly divided into four groups,namely the control group(2 mL/100 g·BW normal saline),the Baatar-7 low-dose group(Baatar7-L group),and the medium-dose group(Baatar7-M group),high-dose group(Baatar7-H group)(giving 2.5,5.0,10.0 g/kg·BW of Baatar-7 liquid),each group of ten rats(male and female half),once a day.Test cycle was 6 w and weighed once a week.After six weeks,we perform blood routine and blood biochemical tests through blood collection,calculate organ index and perform histopathological observation.The results showed that the mice of each dose group were no death in the acute toxicity test,so the compound LD50 could not be obtained.The maximum tolerable dose of mice to Baatar-7 was 10000 mg/kg·BW,the results suggested that Baatar-7 was safe and has no acute toxicity.In the sub-chronic toxicity test,compared with the control group,the weight,blood routine,blood biochemical index and organ index of other groups were not significantly different(P>0.05).By pathological necropsy and tissue section observation,no obvious abnormal changes of other groups were seen,compared to control group,the results suggested that Baatar-7 is safe and has no sub-chronic toxicity.The experiment indicates that the dose scope of Baatar-7 used in the test is safe and non-toxic.