| Objective To observe whether the prolonged application(10 weeks)of Xiaoer Jianpi Ointment affects the liver,kidney and major reproductive organs of rats,and provide experimental data for clinical rational use of the drug in the future.Methods Forty SD rats,male and female,were weaned for about 10 days.The rats were divided into blank group(female),blank group(male),drug administration group(female)and drug administration group(male),with 10 rats in each group.The rats in the drug administration group were given the pills of Xiaoer Jianpi Ointment to be applied during the experiment.One pill on the morning and one pill on the afternoon.The blank groups were not processed.The drug was administered continuously for 10 weeks.During this period,the rats were observed daily,their body weight,food intakes and water consumption were measured and recorded every day.After the final administration,the rats were fasted for 12 hours,anesthetized with 3%phenobarbital solution,blood was taken from the abdominal aorta,and the serum was separated by centrifuge,the levels of Alanine aminotransferase(ALT),Aspartate transaminase(AST),Creatinine deiminase(Cr),Blood urea nitrogen(BUN),Testosterone(T),Estradiol(E2)in the serum were detected by Enzyme-linked immunosorbent assay(ELISA)kits,and the gross morphology of the organs in each group was observed after dissection and weighed to calculate the organ index.and pathological paraffin sections of the relevant organs were prepared and stained with HE staining,histomorphological observation was performed,and finally the significance was calculated and analyzed by SPSS26.0 software.Results(1)Daily observation:the rats in the blank group and the drug-administered group had good growth status,normal autonomic activity and no abnormalities in the tissues and organs,and no rat death occurred.(2)Observation of changes in body weight,food intake and water intake:in this experiment,the body weight of female rats in the blank group increased from 72.4 ± 4.5g to 315.7±24.6g,the body weight of female rats in the drug administered group increased from 72.0±3.5g to 354.2±28.6g,the body weight of male rats in the blank group increased from 77.1±5.8g to 515.5±51.8g,and the body weight of male rats in the drug administered group increased from 76.6±5.6g to 590.8±59.4g.The body weight of the drug administered group(female)showed a significant increase(p<0.05;p<0.01)compared with the blank group(female)at the 9th and 10th weeks,and there was no significant difference in the other weeks(p>0.05).The body weight of the administered group(males)showed a significant increase(p<0.01)from the beginning of week 3 to the end of week 10.compared to the blank group(males).Food intake and water intake tended to increase from 1st to 6th weeks,but to decreased from 6th week onwards in both groups.The intake of food was significantly increased in the 2nd,3rd,5th and 6th weeks in the drug administered group(male)compared to the blank group(male)(p<0.01),the intake of food was significantly increased in the drug administered group(female)compared to the blank group(female)in the 2nd-10th weeks(p<0.05;p<0.01),The amount of water consumed in the 2nd.3rd,5th,6th,7th and 10th weeks was higher in the drug administered group(female)than in the blank group(female),that with significant differences(p<0.05;p<0.01).(3)Observation of serum biochemical indexes:there were no significant difference in serum biochemical indexes ALT,AST,Cr,BUN,T and E2 between the rats in the blank group and the rats in the drug administration group(p>0.05).(4)Cross morphology and organ indices of organs:the size and shape of liver,kindey,thymus,spleen,adrenalgland,uterus,ovary,testis,epididymis and prostate were basically normal between the rats in the blank group and the rats in the drug administered group,finally there was no significant difference in there weights(p>0.05).Except for the testicular index of male rats in the drug administration group,which was lower than that of male rats in the blank group,and the values of which were significantly different(p<0.01),there was no significant difference between the two in the indexes of the other organs(p>0.05).(5)Histomorphological observation of organs:HEstained sections of liver,kidney,testis,prostate,uterus and ovary of rats were observed under microscope.Except for the presence of fatty vacuoles formed by spontaneous lesions in liver tissues,the structure and morphology of all tissues were intact,and there was no significant difference between the two groups of blank and drug administration.Conclusion(1)1.After 10 weeks of continuous administration,Xiaoer Jianpi Ointment did not cause toxic damage to liver structure,tissue morphology and liver function indexes ALT and AST in rats.(2)After 10 weeks of continuous administration,Xiaoer Jianpi Ointment did not cause toxic damage to renal structure,tissue morphology and renal function indexes Cr and BUN in rats.(3)After 10 weeks of continuous administration,Xiaoer Jianpi Ointment did not cause toxic damage to the structure,related tissue morphology and sex hormone indexes T and E2 of female rats’ uterus and ovaries,male rats’ testis and prostate. |
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