痰热清注射液对大鼠的急毒及长毒试验研究  

Experimental on acute and chronic toxicity of Tanreqing Injection in rats

作　　者：张小利 张联众 杜学航 Zhang Xiaoli;Zhang Lianzhong;Du Xuehang(Shanghai Kaibao Pharmaceutical Co.,Ltd.,Shanghai 201401,China;Center for Disease Control and Prevention of Pingchuan District of Biayin in Gansu,Baiyin 730913,China)

机构地区：[1]上海凯宝药业股份有限公司,上海201401 [2]甘肃省白银市平川区疾病预防控制中心,甘肃白银730913

出　　处：《江苏科技信息》2020年第20期70-75,共6页Jiangsu Science and Technology Information

基　　金：上海市2019年度“科技创新行动计划”生物医药领域科技支撑项目,项目编号:19401901000。

摘　　要：目的:观察大鼠尾静脉注射痰热清注射液可能出现的急性毒性、长期毒性反应,为临床前安全性评价提供资料。方法:大鼠尾静脉单次注射最大给药容量(20 mL/kg)的痰热清注射液原液,观察给药后动物出现的急性毒性反应。大鼠尾静脉分别连续注射低(2.50 mL/kg)、中(4.00 m L/kg)、高(6.67 mL/kg)剂量的痰热清注射液原液13周,停药恢复4周,观察大鼠一般状况、体质量、食耗量、眼科、血液学及血清生化学指标,大体解剖及组织病理学变化。结果:急性毒性研究中,未见明显毒性反应。长期毒性研究中,高剂量可使大鼠食耗量减少;给药组个别动物的血液学和血清生化指标出现变化,但无剂量相关性,应属正常波动。结论:大鼠急毒的安全剂量为痰热清注射液原液20 mL/kg;大鼠长毒的安全剂量为痰热清注射液原液6.67 mL/kg。但对于长期高剂量给药,建议就食耗量作进一步观察。Objective:To observe the possible acute and chronic toxicity of Tanreqing Injection in tail vein of rats,and to provide data for preclinical safety evaluation.Methods:The acute toxic reaction of the rats was observed after the single injection of the original solution of Tanreqing Injection with the maximum dose volume(20 ml/kg).In the chronic toxicity study,rats were intravenously treated with original solution of Tanreqing Injection at the doses of 2.50,4.00 and 6.67 ml/kg for 13 weeks and observed for four weeks after administration.Clinical observations,body weights,food consumption,ophthalmoscopy,hematology,blood biochemistry and histopathological findings were examined.Results:No obvious toxic reaction was found in the acute toxicity study.In the chronic toxicity study,high dose of original solution of Tanreqing Injection can reduce the food consumption of rats.The hematological and serum biochemical of individual animals in the administration group changed,but there was no dose correlation and it should be normal fluctuation.Conclusion:The safe dose of acute toxicity in rats was 20 ml/kg original solution of Tanreqing Injection,and the safe dose of chronic toxicity in rats was 6.67 ml/kg original solution of Tanreqing Injection.However,for chronic high-dose administration,it is suggested to make further observation on food consumption.

关 键 词：痰热清注射液 急性毒性 长期毒性 大鼠 

分 类 号：R563[医药卫生—呼吸系统]