摘要
目的观察以杞金颗粒剂(由枸杞子、鸡内金、焦山楂、木瓜等药物组成)喂饲大鼠的多项指标,以探讨杞金颗粒毒理学及安全性。方法实验于2013-03/2011-10在山西省疾控中心毒理实验室完成。选取清洁级Wistar离乳大鼠80只,随机分为4组,即三个剂量组和一个阴性对照组,每组20只。三个剂量组(将药物剂量按比例掺入饲料)分别为高剂量10g/kg(含受试药物100g)、中剂量组5g/kg(含受试药物50 g)、低剂量组1.67 g/kg(含受试药物16.7g)。各组动物单笼饲养,连续喂养30d。观察和记录动物的一般表现、行为、中毒症状和死亡情况。记录每周体质量,食物摄入量,计算食物利用率。测定血液学指标。测定生化指标。观察肝、脾、肾、睾丸等脏器大体变化并称量其质量,计算脏体比,并进行组织病理学切片观察。同时采用Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验等对其进行毒性安全性评价。结果在实验过程中无动物死亡,全部进入结果分析。①实验期间各组动物活动正常,各剂量组在体质量增长、进食量和食物利用率方面与对照组比较差异无显著性意义。②各剂量组血液指标和生化指标检测结果与对照组比较差异均无显著性意义。③各剂量组脏器比与对照组相比差异均无显著性意义。④各剂量组病理组织学方面即肝、脾、肾、胃、肠、睾丸和卵巢均未见特异性病理改变。⑤Ames试验结果显示,直接作用(-S9)或经代谢活化作用(+S9)均不引起自发回变数增加;未呈现致突变性;小鼠骨髓嗜多染红细胞微核率未发生改变,嗜多染红细胞与正染红细胞的比例>0.1,未呈现有致突变性;各剂量组精子畸形率与阴性对照组比较差异均无显著性意义(P>0.05),而阳性对照组精子畸形率与阴性对照组及各剂量组比较差异有高度显著性(P<0.01),说明杞金颗粒在所设剂量范围内未引起小鼠�
Objective The aim of study is evaluating the effect about toxicology and safety of Qijin keli on rat, Rat were breed by Qijin keli to determinate the significance about the Qijin keli to rat, multicriteria were studied. Methods The experiments were completed on 2005-03/2006-01 at toxic department of Shanxi CDC. The clean and weaned 80 rats were divided for 4 groups, one is control and other three are test groups which were high （10g/kg） middle（5g/kg） low（h67g/kg） dose group. They were breed continuously for 30 days, for appreciation of toxicology and safety of Qijin keli on rat. General manifestation, behavior, toxic symptom and deaths were noted. Weights were weighed in every week. Food absorb quantity were recorded. Food using rate were calculated. Tail blood were collected and smeared on 29th day for blood criteria. The rats were decollated after fast for 16hr and vein blood were collected for biochemistry criteria. The liver, spleen, ovary, kidney and testicle were taken and observed change and weighed. The viscera rates were calculated. The pathohistology slices were made. Ames test etc were done for toxicology and safety evaluated. Results All of animal had no death and were analyzed. It showed that all rats behavior were normal. It had no significant difference between the test group and control group. Weight increase and food-intake and food availability etc in dose groups have no significant difference with control group. Blood index and biochemistry index and organ ratio and pathohistology and spontaneity recurring rate and cause mutations etc have no significant difference with control group. Conclusion Qijin keli has no toxicology and side effect to rats various index. It has safety.
出处
《中国医药指南》
2012年第27期451-453,共3页
Guide of China Medicine
基金
山西省科技专项(2011091027)
