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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 To evaluate the safety of L-carnitine injection (5 m L: 1.0 g) for clinical use. Methods The vascular irritation test was performed by intravenous injection of the left aorta on the left and right sides of the body. The rabbit erythrocyte suspension was incubated with the test sample to observe the hemolysis. Using levocarnitine injection (5 m L: 1.0 g) Sensitization at 190 mg / kg and 95 mg / kg was performed three times and no allergic reaction was observed when challenged with 2-fold sensitizing concentration, compared with parallel controls at the same dose and concentration ; L-carnitine injection (5 mL: 1.0 g) was tested for passive cutaneous anaphylaxis at high and low doses of 190 mg / kg and 95 mg / kg respectively. Results of levocarnitine injection of rabbit erythrocyte suspension (in vitro tube method) and the case of vascular stimulation similar to the results of parallel control, no hemolysis, no obvious vascular irritation; in active allergy test Guinea pigs showed no symptoms of allergic reactions, allergic reactions were negative; passive skin allergy test showed no symptoms of blue-colored allergic reactions, allergic reactions negative. Conclusion The clinical efficacy of levocarnitine injection (5 m L: 1.0 g) conforms to the requirements of injectable drug and can be used as the basis for safety evaluation.