摘要
本研究旨在评价乌锦颗粒剂的毒性,为临床安全用药提供理论依据。试验分别以昆明小鼠和Wistar大鼠为研究对象,进行急性毒性试验和亚慢性毒性试验研究。急性毒性试验结果显示,乌锦颗粒剂的半数致死量(LD50)>40g/kg体重,最大给药量为160g/kg体重,相当于临床用药量的80倍;在亚慢性毒性试验中,动物一般情况正常,试验组Wistar大鼠增重和饲料消耗量与对照组相比无显著差异(P>0.05);与对照组相比,高剂量组中雌鼠血清胆红素(T-BIL)、总蛋白(TP)、白蛋白(ALB)、尿素氮(BUN)和肌酐(CREA)及雄鼠CREA和肝脏指数均有显著差异(P<0.05),而其他指标与对照组相比差异均不显著(P>0.05);低剂量组和中剂量组Wistar大鼠血常规、血液生化指标和脏器指数与对照组相比差异均不显著(P>0.05);病理学检查发现高剂量组Wistar大鼠肝脏出现轻微颗粒变性,其他组Wistar大鼠组织结构清晰正常。结果表明,高剂量的乌锦颗粒剂能抑制肝脏对游离胆红素的摄入及蛋白质的合成;低剂量和中剂量乌锦颗粒剂此作用不明显。综合分析,乌锦颗粒剂临床用药是安全的。
In order to evaluate the toxicity of Wu Jin granules for the guidance of clinical treat- ment,the acute and sub-chronic toxicity were assessed in KM mice and Wistar rats, respectively, The results of acute toxicity test suggested that the LD50 of Wu Jin granules was 〉40 g/（kg · BW）, maximal tolerance dose was 160 g/（kg · BW）, equivalent to 80 times of clinical dosage. In sub- chronic toxicity test, the growth and general behavior of the animals appeared normal. Compared with the control group,weight gain and feed consumption of Wistar rats in the treatment groups had no significant difference （P〉0.05）. In high dose group, serum bilirubin （T-BIL）, total pro- tein （TP）,albumin （ALB）,urea nitrogen （BUN） and creatinine （CREA） of female Wistar rats, whereas CREA levels and liver index of male Wistar rats were significant difference （P〈0.05）, and the differences in other indexes were not significant （P〉 0. 05）; Hematological indexes, biochemical indexes of blood and organ index of Wistar rats in low dose group and medium dose group were not significantly different compared to the control group （P〉 0. 05）. Pathological examination results showed that mild granular degeneration existed in liver of Wistar rats in high dose group,whereas appeared clear and normal organizational structure of liver in Wistar rats inother groups. Wu Jin granules could inhibit intake of free bilirubin and hepatic synthesis protein in high dosage,whereas this results were not observed in other groups. Thus, the Wu Jin granules were safe in clinical treatment.
出处
《中国畜牧兽医》
CAS
北大核心
2015年第5期1203-1210,共8页
China Animal Husbandry & Veterinary Medicine
基金
公益性行业专项课题(20130304-17)
国家科技支撑计划项目(2012BAD12B03)
关键词
乌锦颗粒剂
急性毒性
亚慢性毒性
安全评价
Wu Jin granules
acute toxicity
sub-chronic toxicity
safety evaluation
