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目的:评价多种聚氧乙烯脱水山梨醇单油酸酯(吐温80)静脉给药对Beagle犬的致敏性。方法:Beagle犬随机分为5组,每组3只,分别静脉注射4种0.5%吐温80溶液,给药体积10mL.kg-1,前肢静脉恒速注射(速度5 mL.min-1)。观察给药前至给药后24 h每只犬的变化,记录症状出现、消失时间,并根据反应症状的轻重判定级别。给药前、给药过程中、停药后测量动物血压、心率。给药前及停药后10 min取血,ELISA方法检测血浆组胺含量,并结合反应症状级别,综合判定致敏性。结果:0.5%浓度样品3静脉滴注可诱发Beagle犬出现类过敏反应的典型症状,其他3种吐温80诱发犬出现类过敏反应的不典型症状;4种吐温80溶液均可导致Beagle犬出现不同程度的心率加快,血压下降;各组犬血浆组胺升高均未超过1倍以上。0.5%浓度样品2组犬的不典型类过敏反应症状、血压下降程度均较其他组吐温80受试液轻。综合判定,0.5%浓度样品3静脉注射给Beagle犬其类过敏反应为可疑,其他各组受试液均未能诱发Beagle犬出现典型的类过敏反应。结论:吐温80浓度在0.5%时,对过敏体质等特殊人群临床应用仍有一定风险,不可大意。生产工艺对吐温80的致敏性有一定影响,精制后吐温80的安全性有了一定提高,但仍有待进一步研究。
OBJECTIVE: To evaluate the sensitization of Beagle dogs to intravenous administration of polyoxyethylene sorbitan monooleate (Tween 80). Methods: Beagle dogs were randomly divided into 5 groups with 3 rats in each group. Four kinds of 0.5% Tween 80 solution were intravenously injected into the beagle dogs at a volume of 10 mL.kg-1. The forelimb vein was injected with constant velocity (5 mL.min-1) . Observed before treatment to 24 h after administration of each dog changes, record symptoms appear, disappear time, and according to the severity of the reaction to determine the level of symptoms. Before administration, during administration, blood pressure and heart rate were measured after stopping the medicine. Blood samples were collected before administration and 10 min after drug withdrawal, and plasma histamine levels were measured by ELISA. Combined with the level of response symptoms, sensitization was determined synthetically. Results: The typical symptoms of anaphylactoid reaction were induced in Beagle dogs by intravenous infusion of 0.5% concentration sample 3, and the atypical symptoms of allergic reaction in the other three kinds of Tween 80. The four kinds of Tween 80 solution can cause Beagle dogs There are different degrees of heart rate to speed up, blood pressure decreased; histamine in each group did not increase the plasma more than 1 times. The symptoms of atypical anaphylaxis and blood pressure in the dogs in 0.5% concentration group were lower than those in other groups. The results showed that the hypersensitivity reaction in Beagle dogs was suspicious by intravenous injection of 0.5% concentration sample 3, while the other test groups failed to induce typical anaphylactoid reactions in Beagle dogs. Conclusion: Tween 80 concentration of 0.5%, the clinical application of allergic constitution and other special populations still have some risks, can not be taken. The production process has a certain impact on the sensitization of Tween 80. After the purification, the safety of Tween 80 has been improved to a certain extent, but it still needs further study.