摘要
目的本文研究注射用头孢美唑钠的溶血性、刺激性和过敏性,为临床研究提供依据。方法结合肉眼观察法和分光光度法进行体外溶血试验;经兔右耳耳缘静脉注射浓度为100 mg/mL受试物或市售对照品进行血管刺激性试验;采用SD大鼠进行被动皮肤过敏试验(Passive cutaneous anaphylaxis,PCA),致敏浓度分别为150 mg/mL和300 mg/mL;采用豚鼠进行全身主动过敏试验(Active systemic anaphylaxis,ASA),致敏浓度分别为1.6 mg/mL和3.2 mg/mL,于末次致敏后第14 d和21 d分别取半数动物快速静脉注射致敏剂量的2倍进行激发。结果受试物与市售对照品注射用头孢美唑钠均未见体外溶血和红细胞凝聚,对血管无刺激性。被动皮肤过敏试验和全身主动过敏试验的过敏反应发生率为0。结论受试物与市售对照品注射用头孢美唑钠的局部毒性反应结果具有一致性,未见体外溶血和红细胞凝聚,对血管无刺激性,未见过敏反应,可以为临床应用提供安全性依据。
Objective The hemolytic,irritative and allergic effects of cefmetazole sodium for injection were investigated in this study.Methods In vitro,hemolysis test was conducted using visual observation and spectrophotometry.Vascular stimulation tests involve the intravenous administration of 100 mg/mL of the test substance or commercial control substance through the right ear vein of rabbits.A passive skin allergy test was performed on SD rats with sensitization concentrations set at 150 mg/mL and 300 mg/mL respectively.Whole-body active allergy test was carried out on guinea pigs with sensitization doses at 1.6 mg/mL and 3.2 mg/mL respectively,followed by intravenous injections twice the corresponding sensitization dose on the 14th and 21st day after the last sensitization.Results Cefmetazole sodium for injection exhibited no in vitro hemolysis,erythrocyte agglutination,or irritation to blood vessels;furthermore,there was a zero incidence rate of allergic reactions in PCA(Passive cutaneous anaphylaxis)and ASA(Arthus skin reaction)tests.Conclusion The clinical application of cefmetazole sodium for injection has a strong safety foundation because its local toxicity results were in line with those of the commercial control product.
作者
曾业文
李航
梁十
王瑞珍
林子航
关业枝
Zeng Ye-wen;Li Hang;Liang Shi;Wang Rui-zhen;Lin Zi-hang;Guan Ye-zhi(Guangdong Provincial Biotechnology Research Institute,Guangdong Provincial Laboratory Animals Monitoring Center,Guangzhou 510663)
基金
广东省重点领域研发计划项目(项目编号2022B1111020005)。
关键词
注射用头孢美唑钠
溶血性
刺激性
过敏性
局部毒性试验
cefmetazole sodium for injection
hemolytic
irritability
allergic reaction
local toxicity test
