注射用头孢美唑钠临床前安全性评价研究

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Preclinical Safety Evaluation Study of Cefmetazole Sodium for Injection

ZengYe-wen，LiHang，LiangShi，WangRui-zhen，Lin Zi-hang，GuanYe-zhi （GuangdogProvincialBotechologyResearchItitute，GuangdongProvicialLaboratoryAnimalsonitogCnter，Guangzou

Abstract： ObjectiveThe hemolytic，irritative and allergic effects of cefmetazole sodium for injection wereinvestigated in this study.MethodsIn vitro，hemolysis test was conducted using visual observation and spectrophotometry. Vascular stimulation tests involve the intravenous administration of 100mg/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 150mg/mL and 300mg/mL respectively. Whole-body active allergy test was carried out on guinea pigs with sensitization doses at 1.6mg/mL and 3.2mg/mL respectively， followed by intravenous injections twice the corresponding sensitization dose on the 14th and 2lst day after the last sensitization.ResultsCefmetazole sodium for injection exhibited no invitro hemolysis，erythrocyteagutination，or iritation to blood vessels; furthermore，there was a zero incidencerateofallergic reactions inPCA （Passivecutaneous anaphylaxis）and ASA （Arthus skin reaction）tests.ConclusionThe clinical application of cefmetazole sodium for injectionhas a strong safety foundation because its local toxicityresults were in line with those ofthe commercial control product.

Key words：cefmetazole sodium for injection；hemolytic； iritability;allergic reaction；local toxicity test

头孢菌素类（Cephalosporins）抗生素是通过提取头孢菌培养物得到的天然头孢菌素C作为原料，通过半合成技术改造其侧链形成的一类抗生素，是目前临床上广泛使用的一种抗生素，属于 β -内酰胺类抗生素，是7-氨基头孢烷酸（7-ACA）的衍生物[I]。（剩余10146字）