丹参注射液小鼠单次给药毒性试验研究

The study of single-dose toxicity of Danshen Injection in mice

目的观察单次静脉和腹腔注射给予丹参注射液后对小鼠产生的毒性。方法采用经典半数致死量(LD_(50))法进行小鼠单次给药毒性试验,动物分组后以不同的剂量静脉或腹腔注射给药1次,药后观察小鼠反应,检测体重和死亡率,连续观察14 d后剖检,观察主要脏器的病变。结果丹参注射液小鼠单次静脉和腹腔注射给药半数致死量分别为3.2 g·kg^(-1)和6.3 g·kg^(-1)。死亡小鼠毒性症状主要表现为俯卧不动、抽搐、呼吸困难、昏迷、尿失禁继而死亡。结论丹参注射液大剂量腹腔和静脉注射可致小鼠全部死亡,但其半数致死量分别为临床用药剂量的65和129倍,安全范围较大。

Objective To study the single-dose toxicity of Danshen Injection by intravenous and intraperiatoneal injections in mice.Methods The single-dose toxicity of Danshen Injection in mice was evaluated with classical LD50. Animals were divided into different groups and administered with different dose for one time.The general symptoms,body weight and mortality were observed after administration.The animals were autopsied and lesion of main organs were observed after continuous observation for 14 days.Results The LD50 of Danshen Injection in mice was 3.2 g·kg^-1 after intravenous injection and 6.3 g·kg^-1 after intraperitoneal injection.The main acute toxicity symptoms of dead mice were prone position,convulsion,dyspnea,coma,urinary incontinence and eventually to death.Conclusion Danshen Injection can induce all mice to be dead.The LD50 of Danshen Injection in mice was 65 times of clinical dosage for intravenous injection and 129 times of clinical dosage for intraperitoneal injection.The safety scope of Danshen Injection was very large.