两种莲必治注射液急性和长期毒性研究

Acute and long-term toxicity studies on the two kinds of Lianbizhi injectas in male SD rats

目的观察莲必治注射液A和B的急性毒性和长期毒性。方法上下法观察2种莲必治注射液对SD大鼠的急性毒性;连续30 d重复静脉给药观察其对SD大鼠的长期毒性,设置2种莲必治注射液高、中、低各3个剂量组(莲必治注射液A,450,150和50 mg/kg;B,150,50和25 mg/kg)和生理盐水对照组,对一般生理指标、尿常规和尿酶、血液学、血液生化和组织病理进行学检查。结果急性毒性试验结果莲必治A注射液的LD50=2 101 mg/kg,莲必治B注射液的LD50=612.4 mg/kg;连续30 d重复静脉给药后结果,莲必治A和B高剂量组能够引起动物摄食量减少和体重降低,同时给药结束后莲必治A和B高剂量组尿素氮(BUN)、肌酐(CRE)有升高趋势,尿酶N-乙酰-β-D葡萄糖苷酶(NAG)活性升高,尿血红蛋白(ERY)增加,其他血液学、血液生化学、脏器系数及病理学检查均未见显著性变化。结论莲必治注射液对SD大鼠具有潜在肾毒性,推测可能影响肾小球滤过率和肾小管功能,毒性作用与其纯度和剂量有关。

Objective To study the acute toxicity and long-term toxicity of the two kinds of Lianbizhi injectas.Method First,to observe the acute toxic symptoms and to obtain the toxic parameters（such as LD50） by the up and down acute toxicity test.Then the Lianbizhi A injectas in dose of 450,150,50 mg/kg and the Lianbizhi B injectas in dose of 150,50,25 mg/kg were administered to the male SD rats by i.v.in successive 30 days,respectively.Recording the clinical signs,body weight growth and the food consumption,and examining the haematology,blood chemistry,the changes of routine urine and ureases and nec-ropsy and histopathology.Results The LD50 values of the Lianbizhi A and B were 2 101 mg /kg and 612.4 mg /kg,respective-ly.Suppression in body weigh gain,food consumption and the elevating tendency of the levels of BUN and CRE were observed in the high dose group of the Lianbizhi A and B injectas.The levels of NAG and hemoglobin in urine were raised in all the groups of the Lianbizhi A and B injectas.No significant changes were seen in other haematology,blood chemistry,ureases,organ coeffi-cient and histopathology.Conclusion The Lianbizhi Injections are estimated to influence the glomerular filtration rate and tubu-lar reabsorption and its potential nephnotoxic effects on rats are related to its purity and dosage.