气阴两虚证方剂的急性毒性和亚急性毒性效应

Acute toxicity and subacute toxicity effects of qi and yin deficiency prescription

目的研究气阴两虚证方剂的急性毒性和亚急性毒性,为其安全性提供试验依据。方法参照《药物单次给药毒性研究技术指导原则》,对气阴两虚证方剂进行大鼠、小鼠急性经口毒性试验和大鼠30 d喂养试验。结果试验表明,大鼠、小鼠急性经口MTD值>20 g/kg·BW,属无毒级;各试验组在体重、进食量、饲料利用率、脏体比值、血细胞学和生化指标与对照组比较,各项结果均无显著性差异(P>0.05);组织切片检查除动物自发病变外,气阴两虚证方剂未引起动物中毒性损伤。结论气阴两虚证方剂在本试验条件下未显示有急性毒性或亚急性毒性。

Objective To explore the acute toxicity and subacute toxicity of qi and yin deficiency prescription,and provide experimental evidence for its safety.Methods According to the Technical Guidelines for the Toxicity Research of Single Drug Administration.The acute oral toxicity test on mice and rats and the 30-day feeding test on rats were performed.Results The oral MTD value for mice and rats was more than 20 mg/kg·BW,which was non-toxic.There was no significant difference in weight increase,food intake,food utilization,organ coefficient,blood routine examination and blood biochemistry indexes between treatment group and control group(P>0.05).The tissue section examination showed that the prescription for deficiency of both qi and yin did not cause toxic damage to animals,except for spontaneous disease in animals.Conclusion The qi and yin deficiency prescription showed no acute toxicity or subacute toxicity in the tests.