益气解毒汤大鼠急性毒性实验研究OA

Objective:To investigate the acute toxicity of Yiqi Jiedu Decoction in rats,providing experimental support for its clinical application safety.Methods:Preliminary experiment:Thirty SPF-grade female SD rats were randomly divided into low-,medium-and high-dose groups of Yiqi Jiedu Decoction using a random number table method,with 10 rats per group.The rats were given 83.3 g/kg,166.7 g/kg and 333.3 g/kg of Yiqi Jiedu Decoction by gavage within 24 hours(equiva-lent to 16,32 and 64 times the clinical daily dose for adults,respectively,calculated based on body surface area).General condition and mortality were observed for 7 days to assess the dose-response relationship.Based on the results of the prelimi-nary experiment,the maximum tolerated dose(MTD)was determined:another 30 SD rats were randomly divided into a maximum-dose group and a blank control group using a random number table method,with 15 rats per group.Rats in the maximum-dose group received Yiqi Jiedu Decoction at 333.3 g/(kg·time)by gavage twice within 24 hours(6-hour inter-val),with a total daily dose of 666.7 g/kg,while rats in the blank control group received an equal volume of distilled water.After 14 days of continuous administration,the general state,signs and changes in body weight of rats were recorded.At the end of the observation period,blood was collected for routine blood tests[white blood cell count(WBC),hemoglobin(HGB),red blood cell count(RBC),platelet count(PLT)and absolute lymphocyte count(LYM)]and blood biochemistry[alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),blood urea nitrogen(BUN)and serum creatinine(Cr)].The rats were then euthanized and dissected to observe pathological changes in the ma-jor organs(heart,liver,spleen,lungs and kidneys).Results:No deaths occurred in any dose group in the preliminary experi-ment.In the MTD experiment,no deaths occurred in either the blank control group or the maximum-dose group.No signifi-cant abnormalities were observed in the general clinical examination of the maximum-dose group.Compared with day 1 of the experiment,both groups showed a significant increase in body weight on day 7 and day 14;compared with day 7,both groups showed a significant increase in body weight on day 14,with statistically significant differences(P<0.05).No statisti-cally significant differences in body weight were found between the blank control group and the maximum-dose group at the same time points(P>0.05).No abnormal changes related to drug toxicity were observed in routine blood tests(WBC,HGB,RBC,PLT and LYM),blood biochemistry(ALT,AST,ALP and BUN),or histopathological examination of major organs(heart,liver,spleen,lungs and kidneys).Cr levels were elevated,and the difference was statistically significant(P<0.05).But the values remained within the normal physiological range of healthy SD rats.The MTD of Yiqi Jiedu Decoction was de-termined to be 333.33 g/kg,equivalent to 64 times the clinical daily dose for humans.Conclusion:The acute toxicity experi-ment results indicate that at a maximum dose equivalent to 64 times the clinical dose,Yiqi Jiedu Decoction does not cause toxicologically significant acute injury,suggesting its high safety for clinical use.