通脉降脂口服液毒理学研究

Toxicologic Study on Tongmai Jiangzhi Oral Liquid

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7 d;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7 d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≥427.2 g/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。

Objective：To determine the administration safety of Tongmai Jiangzhi Oral Liquid to provide scientific basis and necessary safety data for the advantge and disadvantage ealculation 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 427.2g/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 as 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.