通脉降脂合剂安全性研究  

Safety study of Tongmai Jiangzhi Mixture

作　　者：孙振平 于德龙 仲娜 裴琳 SUN Zhenping;YU Delong;ZHONG Na;PEI Lin(Qingdao Institute of Food and Drug Control,Qingdao Shandong 266071;Qingdao Chengyang District People’s Hospital,Qingdao Shandong 266108)

机构地区：[1]青岛市食品药品检验研究院,山东青岛266071 [2]青岛市城阳区人民医院,山东青岛266108

出　　处：《当代医药论丛》2022年第19期116-119,共4页

摘　　要：目的:对通脉降脂合剂临床用药的安全性进行评价。方法:急性毒性试验:昆明种小鼠40只,随机分为给药组和空白对照组,采用最大给药量法测定小鼠通脉降脂合剂的最大耐受量。长期毒性试验:Wistar大鼠80只,随机分为四组,采用高、中、低3个剂量(144 g/kg、72 g/kg、36 g/kg)为高剂量组、中剂量组、低剂量组大鼠灌胃给药,空白对照组大鼠给予蒸馏水灌胃,每天1次,连续5周,观察大鼠的一般情况,在给药结束期、恢复期观察其血常规及血液生化学、组织病理学指标的变化。结果:小鼠口服通脉降脂合剂的最大耐受量(MTD)为生药量288 g/kg,为临床成人拟日服剂量的288倍。连续给药5周、停药2周,大鼠的体重、摄食量、行为活动、血液学指标、生化学指标及病理组织学指标等均未发现明显异常。结论:通脉降脂合剂安全无毒,临床应用的安全性高。Objective:To evaluate the clinical safety of Tongmai Jiangzhi mixture.Methods:Acute TOXICITY TEST:40 mice of Kunming species were randomly divided into drug administration group and blank control group,and the maximum tolerance of Tongmai Jiangzhi mixture was determined by maximum dose method.Long-term toxicity test:Eighty Wistar rats were randomly divided into four groups.The rats in the high-dose,medium-dose and low-dose groups(144 g/kg,72 g/kg,36 g/kg)were given by gavage,while the rats in the blank control group were given distilled water gavage,once a day for 5 weeks.The general conditions of the rats were observed.The changes of blood routine,blood biochemistry and histopathology were observed at the end of administration and recovery period.Results:The maximum tolerated dose(MTD)of Tongmai Jiangzhi mixture in mice was 288 g/kg,which was 288 times that of adult daily dose.After 5 weeks of continuous administration and 2 weeks of withdrawal,no significant abnormalities were found in body weight,food intake,behavioral activities,hematological indexes,biochemical indexes and histopathological indexes.Conclusion:Tongmai Jiangzhi mixture is safe and non-toxic,with high safety in clinical app lication.

关 键 词：通脉降脂合剂 急性毒性 长期毒性 

分 类 号：R965.3[医药卫生—药理学]