硫酸特布他林雾化液刺激性与过敏性评价  

Evaluation of Irritability and Allergy of Terbutaline Sulphate Solution for Nebulization

作　　者：马晓阳 杨娴 左亚茹 侯海婷 赵方红 MA Xiao-yang;YANG Xian;ZUO Ya-ru;HOU Hai-ting;ZHAO Fang-hong(Pharmaceutical Research Institute of Shijiazhuang No.4 Pharmaceutical Co.,Ltd.,Shijiazhuang 050000,China;Industrial Technology Research Institute of Chemical Sterile Preparations,Shijiazhuang 050000,China;Hebei Large Capacity Injection Engineering Technology Research Center,Shijiazhuang 050000,China;Postdoctoral Research station of Shijiazhuang No.4 Pharmaceutical Co.,Ltd.,Shijiazhuang 050000,China)

机构地区：[1]石家庄四药有限公司研发中心,河北石家庄050000 [2]化学药品无菌制剂产业技术研究院,河北石家庄050000 [3]河北省大容量注射剂工程技术研究中心,河北石家庄050000 [4]石家庄四药有限公司博士后科研工作站,河北石家庄050000

出　　处：《海峡药学》2024年第5期1-4,共4页Strait Pharmaceutical Journal

基　　金：河北省创新能力提升计划项目(225A2704D);河北省高层次人才资助项目(B2022003038)。

摘　　要：目的研究硫酸特布他林雾化液对日本大耳兔呼吸系统的刺激性以及是否会引起豚鼠全身主动过敏。方法呼吸系统刺激性试验:动物分组后连续7天雾化吸入硫酸特布他林,1日4次,单次给药剂量为5 mg/只。给药前后进行笼旁观察,末次给药后24 h解剖取材,检查主要脏器病变。全身主动过敏试验:动物分组后雾化吸入不同剂量的硫酸特布他林,隔日致敏给药1次,共致敏给药3次,末次致敏后第14天和第21天分别每组取3只动物致敏剂量的2倍进行雾化给药激发,激发后观察有无过敏反应出现。结果兔吸入硫酸特布他林雾化液,给药结束有一定的刺激作用,恢复期结束,未见药物延迟或蓄积作用。豚鼠吸入硫酸特布他林雾化液未发生主动全身过敏反应,结果为阴性。结论本研究初步显示了硫酸特布他林雾化液的使用安全性。OBJECTIVE To study the irritation of Terbutaline Sulphate Solution for Nebulization on the respiratory system of Japanese rabbits and whether it can cause active systemic allergies in guinea pigs.METHODS Respiratory system irritation test:After animal grouping,Terbutaline Sulphate Solution for Nebulization was nebulized and inhaled for 7 d,4 times a day,with a single dose of 5 mg.Before and after administration,cage side observation was conducted,and samples were dissected 24 hours after the last administration to examine major organ lesions.Active systemic anaphylaxis test:After animal grouping,different doses of Terbutaline Sulphate Somution for Nebulization was nebulized and inhaled.Sensitize once every other day for a total of three times.On the 14th and 21st days after the last sensitization,take twice the sensitization dose of three animals from each group for nebulization and stimulation.After stimulation,observe for any allergic reactions.RESULTS Rabbits inhaled Terbutaline Sulphate Solution for Nebulization,which had a certain stimulating effect after administration,and the recovery period ended without any drug delay or accumulation.Guinea pigs did not experience active systemic allergic reactions when inhaling terbutaline sulfate aerosol,and the result was negative.CONCLUSION This study shows the safety of Terbutaline Sulphate Solution for Nebulization.

关 键 词：硫酸特布他林雾化液 刺激性试验 全身主动过敏试验 

分 类 号：R965[医药卫生—药理学]