Objective: through the research on the SD series Qiwei sanxiong decoction rats lavage for90 days for long-term toxicity experiment,observed Qiwei sanxiong decoction to long-term medication in animals produce chemicals toxic reactions and severity,toxicity reaction of target organs and the delayed toxicity reaction of recovery and development,and evaluation of toxic effects of dose,provide experimental reference for clinical safe doses.Methods: in this study,69.0g of crude drug /kg(equivalent to 60 times of the clinical dose),34.5g of crude drug /kg(equivalent to 30 times of the clinical dose),17.25 g of crude drug/kg(equivalent to 15 times of the effective dose of > rats 6.25 times)were divided into 3dose groups and 1 blank control group.50 SD rats(half male and half female)were randomly assigned to each experimental group,with 12 rats in each group(14 rats in the control group).The drug was given twice a day,6 days a week,and 1 day intermittently,for a total of 13 weeks.The general behavior,secretion,excreta,body weight,food intake,toxic reaction and death of the animals were observed during administration.After 90 days of administration,half of the animals(male and female)were randomly sacrificed in each group,followed by urine routine,blood routine,blood biochemistry and pathological tissue examination,and part of the organs were weighed precisely to calculate the organ index.The remaining animals were put to death after 14 days of drug withdrawal.Result:1 The influence on rats’ general states.Continuous dosing in 90 days(delivery)and drug withdrawal during the period of 14 days(recovery),control group female 5 to 8 weeks(2.8)appear off color,decreased activity,fasting,depression,and 2 deaths in the future,after the death of the anatomy of the lung congestion,the rest each viscera not seen obvious abnormity,consider lung lavage damage caused.No abnormal secretions were found in the eyes,ears,nose and mouth,and no abnormal urine and feces were found.The animals in the other groups had normal gait,active activities,and no abnormal excitement or body tremor.2 The influence on rats’ body weights and food intake.After the end of the administration period and the convalescence period,the weight of animals in each group gradually increased.There was no significant difference in body weight and food intake betweenmale and female animals in the high,medium and low dose groups and the blank control group(P > 0.05).3 The influence on rats’ urine routines.After the administration period and the end of the convalescence period,there was no obvious abnormality in all the indicators in the urine examination between the administration group and the blank control group,and no significant difference was found(P > 0.05).4 The influence on rats’ blood biochemical indexes.After the end of the administration period,HGB,HCT,PLT and LYM in the high-dose group were significantly reduced compared with the blank control group(P < 0.01).WBC and MCH in the medium dose group were lower than those in the blank control group(P < 0.05),but there was no dose-effect relationship,so there was no biological significance.After the end of the convalescence period,the MCV of the high-dose group was significantly lower than that of the blank control group(P < 0.05),and the change of these indicators may have a certain relationship with the dose.Compared with the blank control group,the RBC in the medium dose group was lower(P < 0.01),and the above indexes showed no dose-effect relationship,so there was no biological significance.5 The influence on rats’ blood biochemistry.After the end of the administration period,PT in the high-dose and medium-dose groups was significantly higher than that in the blank control group(P < 0.01).After the end of the recovery period,ALT in the high-dose group was significantly higher than that in the blank control group(P < 0.05),and PT and NA in the medium-dose group and the low-dose group were significantly higher than that in the blank control group(P < 0.01 and P < 0.05),but there was no dose-effect relationship,so there was no biological significance.6 The influence on rats’ organ weight and organ index.After the administration period and the end of the recovery period,there was no significant difference in viscera index between the animals in the drug administration group and the control group(P > 0.05).7 The results of Histopathological examination.After the drug administration and convalescence period,there were no drug-related pathological changes in the viscera of the animals in the drug administration group and the blank control group.Conclusion: The recommended clinical dosage of qiwei sanxiong decoction has no obvious toxic and side effects,but continuous large dosage may have certain effects on blood routine,coagulation function and liver function. |