左亚叶酸钠注射液局部安全性实验研究  

Study on the local safety of Sodium Levofolinate Injections

作　　者：林鹏 王丽娜 章颖慧 焉媛媛 王秀英 信婷婷 吴英良[1] LIN Peng;WANG Lina;ZHANG Yinghui;YAN Yuanyuan;WANG Xiuying;XIN Tingting;WU Yingliang(School of Life Science and Biopharmaceutical,Shenyang Pharmaceutical University,Shenyang 110016,China;Department of Pharmacology,Liaoning Institute of Drug Control,Shenyang 110036,China;Department of Quality Control,Shenyang Antibiotic Manufacturer,Shenyang 110122,China)

机构地区：[1]沈阳药科大学生命科学与生物制药学院,沈阳110016 [2]辽宁省药品检验检测院药理室,沈阳110036 [3]沈阳抗生素厂质控处,沈阳110122

出　　处：《西北药学杂志》2018年第5期622-625,共4页Northwest Pharmaceutical Journal

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。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 h after 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 h after the drug withdrawal.Guinea pigs were intravenously injected Sodium Levofolinate Injections （0.5 mL） every other day for 3 times successively,and on the 14th 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 h later,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.

关 键 词：左亚叶酸钠注射液 刺激性 全身主动变态 溶血 凝聚 

分 类 号：R965[医药卫生—药理学]