通脉降脂口服液毒理学研究

目的：确定通脉降脂口服液用药的安全性,为药物的利害估计和临床实验提供科学的依据和必要的安全性数据.方法：急性毒性试验：通脉降脂口服液小鼠灌胃,连续观察7d;长期毒性试验：大鼠80只,随机分为通脉降脂口服液三个不同剂量组和对照组.口服给药,连续12周.停药后7d进行血液学测定及病理检验.结果：急性毒性试验测得最大耐受量为≥427.2g/kg（生药量）,相当于成人临床每日口服剂量的554倍,属实际无毒;长期毒性试验表明,通脉降脂口服液三个剂量组血液学检查、肝肾功能测定、主要脏器系数等各项指标与对照组比较差异均无显著性（P〉0.05）;主要脏器病理检验未见异常.结论：通脉降脂口服液口服用量安全,长期使用不会引起毒性作用.

Toxicologic Study on Tongmai Jiangzhi Oral Liquid

Objective: To determine the administration safety of Tongmai Jiangzhi Oral Liquid to provide scientific basis and necessary safety data for the advantge and disadvantage calculation of drugs and clinical experiment.Methods: Acute toxic experiment: Tongmai Jiangzhi Oral Liquid was perfused into rats' stomach,then its effect was observed successively for 7 days.Long-term toxic experiment: 80 mice were randomly divided into three different dosage groups and the controlled group.They were orally given drugs for 12 weeks.The hematological and pathological examination were taken for 7 days after administration.Results: The maximum tolerance dose after the acute toxic experiment was not less than 427.2 g/kg(raw medicine amount),which was equal to 554 times of aducts' oral dose per day.Long-term toxic experiment indicated that there was no remarkable difference between the three different dosage groups and the controlled group(P>0.05) as to the indexes of hematological examinotion,hepatorenal function determination and the main organs' quotient.There was no abnormal condition for the pathologic examination of main organs.Conclusion: Tongmai Jiangzhi Oral Liquid is safe to take orally,and it may not bring about toxic function with a long-term administration.