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卡洛芬注射液安全性研究

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为了研究卡洛芬注射液的安全性,选用新西兰白兔,采用皮下注射方法进行刺激试验,选用豚鼠进行皮肤致敏试验和全身致敏试验,观察卡洛芬注射液对白兔和豚鼠的安全性.结果表明,白兔每天皮下注射卡洛芬注射液(10 mg/kg)1次,连续7d,受试物组和参比品组注射部位均出现发红和溃烂,组织病理学观察可见注射部位溃疡、真皮/皮下/肌肉炎症伴纤维化、表皮增生,恢复期末未见完全恢复,但受试物组恢复程度比参比品组略好;受试物组和参比品组的卡洛芬注射液激发豚鼠皮肤致敏试验和全身致敏试验中均未引起蓝斑等过敏症状.综上所述,受试物和参比品的卡洛芬注射液对动物注射部位均有明显的刺激性,但不会产生皮肤过敏反应,两者安全性基本一致.
Study on the safety of Carprofen injection
In order to study the safety of Carprofen injection,New Zealand white rabbits were selected to perform subcutaneous injection for stimulation test,guinea pigs were selected to perform skin allergy test and systemic allergy test,and the safety of Carprofen injection on white rabbits and guinea pigs was observed.The results showed that in white rabbits,Carprofen injection(10 mg/kg)was injected subcutaneously once daily for 7 consecutive days,redness and ulceration occurred at the injection site in both the test group and the reference product group,and histopathology showed ulcers at the injection site,dermal/subcutaneous/muscle inflammation with fibrosis and epidermal hyperplasia.No complete recovery was observed in the recovery period,but the recovery degree of the test product group was slightly better than that of the reference product group.Caprofen injection could not cause any allergic symptoms in the skin allergy test and the whole body allergy test of guinea pigs in both the test group and the reference group.In summary,both the test object and the reference product Carprofen injection has obvious irritation to the injection site,but can not produce skin allergic reaction,and the safety of the two is basically the same.

Carprofen injectionsecuritystimulation testallergy test

任丽花、吕让、刘冬、李卓伟、李红园、瞿红颖、张沛、杨国辉、王德功

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河北远征药业有限公司 河北省兽药技术创新中心 石家庄市兽药技术创新中心,河北石家庄 050041

卡洛芬注射液 安全性 刺激性试验 致敏试验

2024

中兽医医药杂志
中国农业科学院中兽医研究所

中兽医医药杂志

影响因子:0.203
ISSN:1000-6354
年,卷(期):2024.43(4)