加米霉素注射液特殊安全性试验研究

Special Safety Research of Gamithromycin Injection

关键词:  加米霉素注射液  特殊安全性  皮肤刺激  皮肤致敏  肌肉刺激  红细胞溶血性

Key words:  gamithromycin injection  special safety  skin irritation  skin sensitization  muscle stimulation  hemolysis of erythrocyte

摘要:

通过豚鼠、大白兔的皮肤致敏、皮肤刺激、肌肉刺激、红细胞溶血试验，考察加米霉素注射液的安全性，从而为临床用药提供参考。试验用新西兰大白兔8只进行皮肤刺激，染毒剂量为加米霉素注射液 0.5 mL/只（规格：150 mg/mL）；用白化豚鼠进行皮肤致敏试验，按0.5 mL/kg剂量，以豚鼠背部左侧皮肤进行染毒；用新西兰大白兔24只，进行肌肉刺激试验，在右侧股四头肌注入6、12、30 mg/kg bw，左侧股四头肌注入同样体积的灭菌0.9 %氯化钠溶液作对照；用新西兰大白兔2只，进行红细胞溶血试验，采用体外试管法进行，采心脏血50毫升，制成血细胞悬液，加入受试药物原液温育3h。结果显示，皮肤刺激试验：受试物加米霉素注射液各个时间点的刺激反应积分均值为0；皮肤致敏试验：受试药物组和阴性对照组豚鼠的皮肤过敏反应率为0；肌肉刺激试验：给予受试物各个时间点的刺激反应积分均值为0；红细胞溶血试验：受试药物及阴性对照在3小时内红细胞全部下沉，上清液体均为澄明，溶液中未见有棕红色或红棕色絮状沉淀。本试验表明加米霉素注射剂无皮肤刺激性、不出现过敏反应、无肌肉刺激性、无溶血和凝聚作用，临床上可以肌肉注射使用。

Abstract:

Study on the safety of Gamithromycin injection through skin sensitization, skin irritation, muscle stimulation and erythrocyte hemolysis test in guinea pigs and rabbits, so as to provide reference for clinical medication.Methods Do the skin irritation test with 8 only New Zealand white Rabbit, and the dose of the drug was 0.5 ml (specification: 150mg/ml); The skin sensitization experiment was carried out with Albino guinea pig, and then Press 0.5ml/kg dose to dye the skin of guinea pig''s left back; do the muscle stimulation test with 24 New Zealand White Rabbits, injection of 6, 12,30mg/kg BW into the right femoral four- head muscle, the left thigh four-head muscle was injected with the same volume of sterilized 0.9 sodium chloride solution as a control; do the erythrocyte hemolysis test with 2 New Zealand white rabbits by external test tubemethod , collect heart blood 50 ml,make blood cell suspensions,and then add the liquid temperature of the tested medicine 3h.Skin irritation test:The average value of stimulating reaction points of the subjects with Gamithromycin injection at different time points was 0. Skin sensitization test: The allergic reaction rate was 0 which Guinea pigs were treated with the tested drug group and the negative control; Muscle stimulation test: The mean value of stimulation reaction points at each point was 0; Hemolysis of erythrocyte test: the red cells of the tested drugs and the negative control all sunk in 3h, and the supernatant liquid was clear, no brown or red-brown flocculent precipitate was seen in the solution. The results showed that no skin irritation, no allergic reaction, no muscular irritation, no hemolysis and condensation in the injection of Gamithromycin injection,it is clinically safe enough for muscle injection.