注射用兰索拉唑的安全性评价
过敏反应,,安全性评价；兰索拉唑；过敏反应；毒性,1材料,2实验方法与结果,3结果及讨论,参考文献
摘 要 目的 评价国产注射用兰索拉唑的安全性。方法 将注射用兰索拉唑配成适当浓度，观察豚鼠静脉注射后有无过敏反应、家兔静脉注射有无血管刺激性及热原反应、体外溶血试验中是否具有溶血和血球凝集作用，小鼠静脉注射的急性毒性。结果 豚鼠静脉注射兰索拉唑无过敏反应，家兔静脉注射兰索拉唑无血管刺激性及热原反应，体外溶血试验无溶血和血球凝集作用，小鼠静脉给药的LD50及95%的可信限为163.8 mg/kg和150.7～178.0 mg/kg。结论 该药可供静脉注射试用给药。关键词 安全性评价；兰索拉唑；过敏反应；毒性
Safety evaluation of lansoprazole for injection
HE Xiaojing, CHEN Guang, DING Xiaofei, LIU Yulan
(1.Department of Pharmaceutics, Second Hospital of China Medical University, Shenyang 110004, China; 2.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)Abstract Objective To evaluate safety of lansoprazole for injection. Methods Five experiments were used including allergic test induced by lansoprazole in guinea pigs, haemolysis and blood cell agglutination test in vitro and stimulation test in blood vessel and pyrogen test in rabbits, acute toxicity test in mice. Results After lansoprazole vein injection, no allergic reactions in guinea pigs, no stimulation and pyrogeninduced fever in rabbits, were observed. Lansoprazole 1 mg/mL caused no haemolysis and blood cell agglutination within 3 hours in vitro. LD50 (mice, intravenous) and 95% confidence limit were 163.8 mg/kg and 150.7~178.0 mg/kg, respectively. Conclusion Lansoprazole is safe for injection. ......
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