The Long-term Toxicity On Rats Was Studied By Astragalus Extract AST-132

Objective:To observe the toxicity and severity of the rats that were given AST-132 for 90 consecutive days,the main toxic target organs or target tissues and their damage reversibility,determine the non-toxic response dose,and compare it with the original process,provide a reference for clinical designers to use safe dose and primary monitoring indicators.Method: In this experiment,240 SD rats were selected,male and female half,divide randomly into six groups.Negative control group(A),in the control group(B),AST-132 original process group(C),AST-132 low dose group(D),AST-132 medium dose group(E),AST-132 high dose group(F).Each group of 40 is male and female.The doses of AST-132 high,medium and low doses were 29.7,9.9,3.3 g(crude drug)/kg·bw(the scale of the clinical trials was 54,18 and 6 times respectively),the AST-132 original process dose was 29.7 g/kg,the negative control group was given ultra-pure water,the auxiliary control group was given a supplementary material that was consistent with the concentration of high dose,the AST-132 original process group,AST-132 low,medium and high dose group gave the corresponding dose,all use the stomach to give the medicine,The volume is15ml/kg,one times a day,for 90 days in a row.During the test,observe animal appearance,activity,gland secretion,breath,fecal character,etc.Weight is measured at 0,2,3,5,7,11,14 days once a week,and adjust to the dosage according to weight,measure the amount of food you eat in the first half,2,3,5,7,11,14 days.The animals were executed in 48 and 91 days respectively,And to carry out the examination of blood chemistry,blood biochemistry,pathology,etc.The rest of the animals stopped for four weeks to recover.Results:(1)General observation:The AST-132 original process group showed an animal death on the 80 nd day of the drug,in general anatomical observation,the tracheal esophagus is broken and the corners of the mouth are brown,the AST-132low-dose group showed an animal death on the 64 th day of the drug,the dissection of the trachea esophagus was observed in general,and it was determined that the animal deaths caused by operation error were not related to the subject matter.None of the other animals were observed significantly.(2)Food intake:The AST-132 original process group,AST-132 high,middle and low dose groups were given 90 days in a row of the stomach to feed the animal and the food intake was not significantly abnormal.(3)Weight:AST-132 set of the original process during the drug can cause male animal body weight growth slows,withdrawal can be restored,AST-132 high,medium and low dose group of 90 consecutive days lavage dosing animals not seen obvious abnormity.(4)Hematology:The AST-132 original process group,AST-132 high,middle and low dose groups were treated for 90 consecutive days in the stomach for the examination of the hematology of the drug.(5)Blood biochemistry:The AST-132 original process group,AST-132 high,middle and low dose group were treated for 90 consecutive days in the stomach to give the drug animal blood biochemistry examination without apparent abnormality.(6)Eye:The AST-132 original process group,AST-132 high,middle and low dose group were treated for 90 consecutive days in the stomach for the examination of the stomach for the examination of the animals.(7)Urine:The AST-132 original process group,AST-132 high,middle and low dose groups were treated for 90 consecutive days in the stomach for the urine examination of the animal without any apparent abnormality.(8)Bone marrow:The AST-132 original process group,AST-132 high,middle and low dose groups were given 90 days in continuous irrigation of the stomach for the medicine and the animal marrow was not seen clearly abnormal.(9)The weight and the coefficient of the organ:The AST-132 original process group,AST-132 high,middle and low dose groups were given 90 days of continuous irrigation of the stomach and the weight and coefficient of the organ.(10)Histopathological:The AST-132 original process group,AST-132 high,middle and low dose groups were treated for 90 consecutive days in the stomach to administer the histopathological examination of the drug and the histopathological examination of the drug was not obvious.Conclusion:(1)The AST-132 non-toxic reactive dose NOAEL is 29.7 g/kg(the high dose,which is 54 times the size of a person’s clinical dosage).(2)AST-132 had no apparent toxicity to the normal SD rats for 90 consecutive days.(3)The AST-132 process of filling the stomach for 90 days in a row can cause the male animal to lose weight and recover.