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目的:比较注射用与药用聚氧乙烯脱水山梨醇单油酸酯(吐温-80)的类过敏反应特点,以探讨不同级别吐温-80的安全性。方法:小鼠耳廓血管通透性分析:将ICR小鼠随机分组,包括生理盐水组、阳性药Compound 48/80 25 mg.kg-1组、0.2%,1%,5%的药用吐温-80和相同浓度的注射用吐温-80组,分别一次性尾静脉注射含0.4%伊文思蓝的各种受试物(20mL.kg-1),观察给药后30 min后动物的行为学变化及耳廓蓝染情况。记录给药后各组动物耳廓血管通透性增高反应的阳性率,按照耳廓蓝染程度评分,并定量测定耳廓伊文思蓝渗出量。大鼠皮肤血管渗透性试验:将6只Wistar大鼠分别一次性尾静脉注射0.6%伊文思蓝0.4 mL,10 min后沿脊柱两侧皮内注射50μL 5%葡萄糖,Compound 48/80 10 g.L-1,0.2%,0.4%,1%,5%的药用吐温-80和注射用吐温-80,20 min后记录注射点的皮内蓝染面积,测定注射点的伊文思蓝渗出量。结果:5%的药用吐温-80和注射用吐温-80可造成ICR小鼠耳廓血管通透性明显增高,而且药用吐温-80血管通透性增高程度明显强于注射用吐温-80;其他浓度吐温-80未造成明显小鼠耳廓蓝染。不同浓度的吐温-80溶液在注射部位造成一定程度的蓝斑,而且相同浓度的注射用吐温-80蓝斑直径较药用吐温-80的蓝斑直径小,除阳性药外,各组伊文思蓝渗出量无明显差距。结论:吐温-80有明显的增强血管通透性的作用,提示其有致类过敏作用,并且其致类过敏作用有一定的剂量效应关系,另外注射用吐温-80比药用吐温-80安全性高,但应严格控制用量以降低类过敏反应的发生。
OBJECTIVE: To compare the allergic reaction characteristics between injectable and medicinal polyoxyethylene sorbitan monooleate (Tween-80) in order to explore the safety of different levels of Tween-80. Methods: The mice auricle vascular permeability analysis: ICR mice were randomly divided into normal saline group, positive drug Compound 48/80 25 mg.kg-1 group, 0.2%, 1%, 5% medicinal spit 80 and the same concentration Tween-80 injection group, a variety of test substances (20mL.kg-1) containing 0.4% Evans blue were injected into the tail veins at a time, and the animals were observed 30 minutes after the administration Behavioral changes and pinna blue dye situation. The positive rates of vascular permeability enhancement in the auricles of each group were recorded and scored according to the degree of auricle blue staining, and the amount of Evans blue exudate of the auricles was quantitatively determined. Rat skin vascular permeability test: Six Wistar rats were injected with 0.6% Evans blue once a single intravenous injection. After 10 minutes, 50 μL of 5% glucose was injected intradermally on both sides of the spine. Compound 48/80 10 gL- 1, 2%, 0.4%, 1%, 5% of medicinal Tween-80 and Tween-80 for injection 20min after injection of intradermal blue dye area injection point of Evans blue exudate the amount. Results: 5% Tween-80 and Tween-80 injection could significantly increase the auricular vascular permeability of ICR mice, and the increase of medicinal Tween-80 vascular permeability was obviously stronger than that of injection Tween -80; other concentrations of Tween-80 did not cause obvious blue aureus in mice. Different concentrations of Tween -80 solution caused a certain degree of blue spots at the injection site, and the same concentration of Tween-80 blue spot diameter for injection compared with the medical Tween -80 blue spot diameter is small, in addition to the positive drug, each Group Evans blue exudation no significant difference. Conclusion: Tween-80 significantly enhances vascular permeability, suggesting that it has a class of allergic effects, and its allergic effects caused by a certain dose-effect relationship, another injection Tween -80 than the drug Tween- 80 high safety, but should be strictly controlled dosage to reduce the occurrence of allergic reactions.