Acute Toxicity Test of Qiangli Bupi Paste

医院制剂补脾强力膏的急性毒性试验（英文）

[Objective] The toxicity of Qiangli Bupi Paste was investigated, to provide a test basis for its further development and safe use. [Method] Forty Kunming mice, half male and half female, were selected and divided into the CK group and the Qiangli Bupi Paste group, each of which included 20 mice. The acute toxicity of Qiangli Bupi Paste was observed by the maximum administration dosage method. No mice and abnormal response were observed within 14 d in various groups. The tested animals were also subjected to anatomical observation. [Result] All the tested animals survived in the test, and behaved normally, with glossy hair. Their body weights accorded with the growth regularity. During the anatomy, no important vis- ceral organs showed pathological changes, and there were no significant differences in body weight between the two groups before administration, on the 7~ after ad- ministration and the 14 d after administration （P〉0.05）. [Conclusion] In the acute toxicity test of Qiangli Bupi Paste, the maximum administration dosage was 48 g/kg （equivalent to 96 times of the daily dose of adult in clinic）, and no obvious toxic response was observed.

[目的]观察医院制剂补脾强力膏的急性毒性,为其进一步研发及安全使用提供试验依据。[方法]选用昆明种小鼠40只,按体重随机分成对照组和补脾强力膏组,每组20只,雌雄各半。采用最大给药量法观察补脾强力膏的急性毒性,观察各组小鼠14天内出现的死亡及反应情况,试验结束后,称重后处死做大体解剖学观察,如有异常则进一步做组织病理学检查,试验期间的死亡动物立即进行解剖学检查。[结果]试验动物全部存活,行为自如,被毛光亮,饮食排便无异常,体重增加符合生长规律,解剖后未见重要组织脏器存在病理改变,给药前、给药后第7天和第14天补脾强力膏组小鼠体重与对照组小鼠体重无统计学差异(P>0.05)。[结论]在补脾强力膏的急性毒性试验中,补脾强力膏的最大给药剂量为48g/kg(相当于临床成人日剂量的96倍),未见明显毒性反应。