仔泻康口服液的急性毒性和亚慢性毒性试验研究

Study on Acute and Sub-chronic Toxicity Study of Zixiekang Oral Liquid

试验旨在通过小鼠急性毒性试验和大鼠亚慢性毒性试验对仔泻康口服液进行安全性评价,为临床安全用药提供理论依据。在急性毒性试验中,采用最大给药剂量对36只昆明小鼠进行灌胃给药。在亚慢性毒性试验中,将80只大鼠,随机均分成高、中、低剂量组和对照组,高、中、低剂量组分别按24、12和6g/kg体重灌胃给药,对照组给予等体积生理盐水,连续给药30d,停药后称量大鼠体重、检测血常规指标、血液生化指标、计算脏器指数并观察组织病理变化等。结果显示,在急性毒性试验中,各剂量组均无小鼠死亡,无法计算LD50,最大耐受量试验也无死亡情况;在亚慢性毒性试验中,该口服液对大鼠生长发育没有影响;经剖检,仅高剂量组可见中央静脉远端的肝细胞有不同程度的肿大,但未见坏死和炎性反应,其他各剂量组的实质器官均未发现异常变化;各剂量组血液学指标、血液生化指标和脏器指数均在正常范围内,与对照组相比均无显著差异(P>0.05)。结果表明,根据外源化学物急性毒性分级(WHO)标准,该制剂属于无毒物质,安全性较高,在合理剂量下,临床使用仔泻康口服液是安全的。

The aim of this experiment was to evaluate the safety of Zixiekang oral liquid by acute toxicity test in mice and sub-chronic toxicity test in rats,so as to provide theoretical basis for clinical use of drugs.Acute toxicity test was conducted in 36 mice by oral administration with the maximum dose method.In sub-chronic toxicity test,80 rats were randomly divided into high,medium,low dose and control groups,the respective dose of the experimental groups were 24,12 and 6 g/(kg·BW)by oral administration,and the control group was given saline at the same volume for 30 days.The weight of the rats was measured after withdrawal.The blood routine index,blood biochemical index,viscera index were calculated.The results showed that no mice died in acute toxicity test,LD 50 could not be calculated,and there was no death in maximum tolerance test.In the sub-chronic toxicity test,weight gain of Wistar rats in the treatment group had no significant effect;There were no distinct abnormal changes in parenchymal organs other than the hepatocytes at the distal end of the vein showed swelling of varying degrees while no necrosis or inflammatory reaction in high dose treatment group,and there was no significant difference in hematological,biochemical and visceral indexes compared with control group(P>0.05).According to the acute toxicity of xenobiotics classification standard(WHO),the formulations were no toxic substances,high safety.Thus,the Zixiekang oral liquid was safe in clinical treatment.