庆大霉素和林可霉素注射液的毒理学试验研究

为对庆大霉素和林可霉素注射液的安全性进行毒理学评价,采用急性毒性试验、溶血试验、局部血管刺激性试验、肌肉及皮肤刺激试验及豚鼠全身用药的过敏试验,考察庆大霉素和林可霉素注射液制剂的安全性。结果表明,庆大霉素和林可霉素注射液对小鼠肌肉注射的LD50为4.989 mL/kg,0.1~0.5 mL该注射液在4 h内对兔红细胞不产生溶血和凝聚作用;静脉注射部位血管及周围组织均未见充血、水肿、出血和坏死等病理改变,肌肉注射部位充血范围在0.5 cm×1.0 cm以下,4块股四头肌反应级的最高与最低之差等于0,家兔四块股四头肌反应级之和小于10;以相当于临床用量2倍的剂量涂抹皮肤,停药后1、24、48、72 h镜下观察均未见明显异常的病理变化;豚鼠首次致敏后第14天及第21天静脉注射液攻击,在观察期内未见过敏反应。表明庆大霉素和林可霉素注射液在该试验条件下是安全的。

Experimental Study on the Toxicology of Gentamicin and Lincomycin Injection

To evaluated the safety of Gentamicin and Lincomycin injection,by acute toxicity test,hemolysis test,local vascular,muscleand skin irritation tests and systemic allergy test in guinea,the safety of Gentamicin and Lincomycin injection was inspected.LD50 of Gentamicin and Lincomycin injection by intramuscrular adminstration in mice was 4.989 mL/kg,hemolysis or coacervation in the red blood cells in rabbts did not occur for 0.1 to 0.5 mL of the injection in 4 h;Pathological changs such as hyperaemia,edema or h...