遵义医科大学学报2023，Vol.46Issue(12)：1133-1140,8.
消癌舒胶囊急性毒性及长期毒性的实验研究
Experimental study on the acute and long-term toxicity of Xiao Ai Shu capsules in rats
摘要
Abstract
Objective To study the acute toxicity and long-term toxicity of Xiao Ai Shu(XAS).Methods 40 female KM mice were randomly divided into four groups,and XAS was administered by single gavage at 2.36,2.94,3.68 and 4.6 g/kg,0.2 ml/10 g each time.The general conditions of the mice as well as their poisoning and deaths were observed,and the LD50 was determined after 14 consecutive days of observation;20 female KM mice were administered with a dose of 27.6 g/kg by gavage at 3 times,with a volume of 0.4 ml/10 g.The gen-eral conditions and toxic reaction of the mice were observed,and the maximum tolerance multiple of XAS was calculated after continuous observation for 14 days.120 female SD rats were randomly divided into four groups,with 30 rats in each group.The groups were:low,medium,and high dose groups(receiving 1,2.3,and 4.6 g/kg of the drug,respectively),and a blank control group.The drug was administered via gavage once daily.Body weight and food intake were measured weekly.After 3 and 6 months of treatment,as well as one month af-ter drug discontinuation(recovery period),10 rats from each group were sacrificed to assess hematological,ser-um biochemical,and organ coefficient markers,and various histopathological indexes.Results Acute toxicity ex-periments showed that there was no death during the experimental period in all groups of mice,the general condi-tion was good,the LD50 could not be calculated,and the maximum tolerated dose of mice was 375 times of the human dose;long-term toxicity experiments showed that the body weight and food intake of the rats decreased af-ter 3 months(P＜0.01)of XAS administration,and its administration for 6 months led toless food intake(P＜0.05)which returned to normal one month after withdrawal of the drug;after 3 months of administration,RBC,HGB,HCT,MCHC,PLT increased in the administered group,which was statistically significant compared with the control group(P＜0.05 or P＜0.01),and no abnormalities were found in other hematological and serum bi-ochemical indices.After 6 months of continuous administration,NEUT,UREA,GLU increased,and the per-centage of LYMPH,TP,ALB decreased in the drug-dosing group,which was statistically significant compared with the control group(P＜0.05 or P＜0.01),and no abnormality was found in the other hematological and se-rum biochemical indexes.All the hematological and serum biochemical indexes returned to normal after withdrawl of XAS for a month.The coefficients of heart,liver,spleen,lung,kidney,brain,ovary,uterus and other organs and their histomorphology of the rats in the dosage groups of XAS were not obviously abnormal in the administra-tion of the drug at 3,6 months and the recovery period.Conclusion There is no obvious acute toxicity and long-term drug toxicity reaction for XAS consumption,and the clinical dosage of the drug is safe.关键词
消癌舒/安全性评价/急性毒性/长期毒性Key words
Xiao Ai Shu/safety evaluation/acute toxicity/long-term toxicity分类
医药卫生引用本文复制引用
金海,张世考,龙良鑫,李映莹,陈名吉,黄南渠,聂晶,王井洪,金凤..消癌舒胶囊急性毒性及长期毒性的实验研究[J].遵义医科大学学报,2023,46(12):1133-1140,8.基金项目
贵州省中药民族药2011协同创新中心[NO:黔教技(2022)026] （2022）
贵州省科技厅基础研究计划项目[NO:黔科合基础-ZK(2023)重点058]. （2023）
