【摘要】 目的对左亚叶酸钠注射液进行安全性评价,为临床用药安全提供依据。方法兔耳缘静脉给予左亚叶酸钠注射液50mg·kg-1,每日1次,连续给药5d,末次给药96h后对注射部位进行病理组织学检查;兔股四头肌给予质量浓度为50mg·mL-1的左亚叶酸钠注射液1.0mL,48h后对注射部位进行病理组织学检查;豚鼠隔日腹腔注射左亚叶酸钠注射液0.5mL,连续注射3次,于末次致敏后第14天静脉注射1.0mL进行激发,观察给药后动物有无变态反应症状;分别将0.1~0.5mL左亚叶酸钠注射液加入氯化钠注射液中,使总体积为2.5mL,再加入兔红细胞混悬液2.5mL,放置3h,观察对兔红细胞悬液的溶血及有无红细胞凝聚作用。结果左亚叶酸钠注射液无明显血管刺激性、肌肉刺激性、溶血和凝集反应,豚鼠全身主动变态性实验为阳性。结论左亚叶酸钠注射液基本符合注射剂的安全要求,临床应用时应密切关注其变态反应的发生。更多还原

【Abstract】 Objective To study the safety of Sodium Levofolinate Injections and to provide basis for clinic use.Methods By ear veins,rabbits were intravenously injected Sodium Levofolinate Injections(5 mg·kg^-1,once a day and continuously for 5 d).Histopathologic examination for the injection sites was carried 96 hafter the drug withdrawal.By quadriceps femoris,rabbits were intravenously injected Sodium Levofolinate Injections(50 mg·kg^-1,1.0 mL for one time).Histopathologic examination for the injection sites was carried 48 hafter the drug withdrawal.Guinea pigs were intravenously injected Sodium Levofolinate Injections（0.5 mL）every other day for 3 times successively,and on the 14 th day after the last sensitization,1.0 mL Sodium Levofolinate Injection was intravenously injected to arouse the reaction.Sodium Levofolinate Injections（0.1-0.5 mL）were diluted into different volumes of Sodium Chloride Injections to make the final volume 2.5 mL,and then rabbit erythrocyte suspension 2.5 mL was added.3 hlater,hemolyzation and agglutination of rabbit erythrocyte were observed.Results Sodium Levofolinate Injections did not induce obvious vascular and muscle irritating effects and hemolysis and agglutination reaction,but the active systemic anaphylaxis test was positive.Conclusion Sodium Levofolinate Injections were safe under the experimental conditions,but it should be concerned that whether allergic reaction will occur after clinical application.更多还原