摘要
旨在考察西潘莲颗粒对小鼠的急性毒性和大鼠的亚慢毒性作用,以评价其安全性,为临床用药提供理论依据。在急性毒性试验中,分不同浓度给小鼠灌胃给药,测试西番莲颗粒的半数致死量(LD50)和最大耐受剂量,在亚慢性毒性试验中,西番莲颗粒以3.3、1.65、0.825g/kg的剂量对SD大鼠连续灌胃4周,并观察其生理状况及其体重变化情况,在第4周周末对大鼠组织病理学、血液生化指标和血常规进行检测。结果表明,西番莲颗粒各剂量组均不引起小鼠死亡,无法测出LD50,最大耐受剂量为16.5g/kg体重;在对大鼠的亚慢毒性试验中,连续给药期间未见大鼠有不良反应,试验组大鼠在增重、血常规和血液生化指标上与对照组无显著差异或均在95%正常值范围内波动,在各脏器未发现异常组织病理学变化。说明受试药物西番莲颗粒实际无毒,安全可靠。
This study aimed to evaluate the safety of Passifloragranules in mice and rats by acute toxicity and sub-chronic toxicity experiments,respectively,for providing theoretical basis in clinical use of Passifloragranules.In the acute toxicity study,the granules were administrated in different concentrations by intragastric method of in mice,the LD50 value and its maximum tolerance dose were evaluated.In the subchronic toxicity experiment,the granules were administrated in three concentration levels,3.3,1.65,0.825g/kg,respectively in SD rats by intragastric method for 4weeks.The physiological status and the weight gain of the rats were recorded daily or weekly during the experiment.The hematological and bio-chemical parameters were measured and the histopathological examination was performed at the end of the fourth week.As a result,there was no death or any fitness problem in mice of each group received the Passiflora granules,and the maximum tolerated dose was 16.5g/kg body weight.In the sub-chronic experiment in SD rats,there were no side effects in all the rats during the long term experiment,there were no significant differences in the body weight gains,blood routines,blood biochemical indexes between the treatment groups and control group.The histopathological result also revealed no lesions in all tissues tested.In conclusion,Passifloragranules showed no toxicity in mice and SD rats,which would be safe in clinical application.
引文
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