左卡尼汀注射液安全性评价的研究

A Investigation on the Safety of Clinical Application of Levocarnitine Injection Agent

目的评价左卡尼汀注射液(5 m L:1.0 g)临床用药的安全性。方法血管刺激性试验采用耳缘静脉注射,同体左右侧自身对比的方法;试验用兔红细胞混悬液与供试品温育,观察溶血情况;用左卡尼汀注射液(5 m L:1.0 g)在190 mg/kg和95 mg/kg剂量条件下进行致敏3次,并用2倍体积致敏浓度进行激发时均未见过敏反应症状,与平行对照品在相同剂量和浓度下进行比较;左卡尼汀注射液(5 m L:1.0 g)在高剂量190 mg/kg和低剂量95 mg/kg时进行被动皮肤过敏试验。结果左卡尼汀注射液在对家兔红细胞混悬液(体外试管法)和血管刺激的情况下结果与平行对照品类似,无溶血作用,也无明显的血管刺激反应;在主动过敏试验中豚鼠均未出现过敏反应症状,过敏反应为阴性;被动皮肤过敏试验豚鼠均未出现蓝斑过敏反应症状,过敏反应阴性。结论左卡尼汀注射液(5 m L∶1.0 g)临床用药符合注射用药的要求,可以做为安全性评价的根据。

Objective In order to investigate the safety of clinical application of Levocarnitine Injection（ 5 m L： 1. 0 g）. Method Ear vein injection was used to evaluate the vascular irritation of rabbits,using left and right side of the same animals for comparison. The rabbit erythrocyte suspension was incubated with the test sample and then observed the hemolysis. Levocarnitine injection agent（ 5 m L： 1. 0 g） at 190 mg / kg and 95 mg / kg three times was gaven to the rabbits for sensitization,respectively. The symptoms of allergic reaction were not found when the sensitization concentrations were stimulated by 2 times volume,compared with a parallel reference in the same dose and concentration; Levocarnitine Injection（ 5 m L： 1. 0 g） in the high dose 190 mg / kg and a low dose of95 mg / kg for passive skin allergy test. Result Levocarnitine Injection on rabbit red blood cell suspension（ in vitro method） and vascular stimulation was similar to the parallel control,with no hemolysis,no significant vascular stimulation. The symptoms of allergic reaction were not occurred in guinea pigs in the active allergic test.,Allergic reaction was negative. Conclusion Levocarnitine Injection（ 5 m L： 1. 0 g） of clinical medicine meet the requirements of injection drug and can be used the base of safety evaluation.