| The proportion of diseases of reproductive diseases in post partum of female animals is large in clinic.Because the lower resistance of postpartum female animals and the body has wounds,once it is not treated,it will easily lead to infection,causing inflammation of the reproductive system,and causing the elimination of female animals in severe cases.Yimu Shenghua San is a drug for preventing postpartum diseases of female animals.It has the functions of promoting blood circulation,clearing away heat and detoxifying,and promoting the discharge of lochia.As a new veterinary drug,Yimukang granule have uncertainty safety.According to the relevant requirements of the “Management Measures for the Development of New Veterinary Drugs” and the announcement of the former Ministry of Agriculture No.442,preclinical toxicology study evaluation is carried out.The study content mainly includes three parts: acute toxicity study,sub-chronic toxicity study and reproductive toxicity study.The study results are as follows:1.Acute toxicity test: During the oral administration of SPF Kunming mice,no death,mental and behavioral status,normal body weight,normal feeding,organ weight,organ index and histopathology were observed.Significant differences were not observed.There was no significant difference between each drug-administered group and the control group(P>0.05).The maximum dose was 19.2 g/kg.The Yimukang granule is safetywith mice.2.Sub-chronic toxicity test: All rats survived during oral administration of SD rats for 30 days,and each dose group(15.0,7.5,1.5 g /(kg·d))and the control group The various observation indexes of rats were normal.The differences in body weight,body weight-gain,food consumption,blood physiology and serum biochemistry,organ weight,organ index and histopathology were not significantly different from those when compared with control values(P < 0.05)..Yimukang granule has no chronic toxicity to rats.3.Reproductive toxicity test:3.1 Reproductive toxicity test of sexually mature female mice.During the 15 d oral gavage administration study,all female mice survived,their behavior was normal,body weight,food intake,weight of genital organs(uterus,ovary)and organ index and pathology The histology and other indicators were normal,and the dose groups(0.6,2.4,9.6 g /(kg · d))were significantly different from the control group(P > 0.05),indicating that Yimukang granules against mature female mice the reproductive system has no adverse effects;3.2 Embryo-fetal developmental toxicity test,pregnant mice during the dosing period(pregnancy 6-15d)and feeding period,the female's various behaviors are normal,body weight,organ weight and organ index are normal,each of the fetal mice developmental indicators(uterus(including fetal weight),total implantation number,live birth,stillbirth,absorbed fetus,teratogenicity)were not different from the control group(P>0.05),the results indicate that Yimukang granule has no adverse effects on pregnant mice and fetal mice;3.3 Perinatal toxicity test of mice,the maternal period of administration(from the 15 th day of pregnancy to the weaning of the pups)and the feeding period,the various behaviors of the female mice are normal,the body weight,organ weight and organ index are normal,the weight of progeny mice,growth and development,physiological development time,neonatal mice reflex time,organ weight and index,histopathology and progeny reproductive behavior were normal,and the difference was not significant compared with the control group(P>0.05).Yimukang granule have no adverse effects on perinatal mice and their descendants;Taken together,the acute toxicity of Yimukang granule on mice,the sub-chronic toxicity of rats and the reproductive toxicity of mice do not induce any adverse effects,when compared to the untreated control group of animals..our results indicate that Yimukang granule does not induce any adverse effects in animals.These results could contribute to further investigations of its the next clinical study. |
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