Wang Yunting, Li Chunying, Yi Yan, Qin Lin, Zhao Yong, Li Guiqing, Cong Xudong, Cao Sumin, Liang Aihua
Capital Medical University, School of Traditional Chinese Medicine, Beijing 100069, China.
Zhongguo Zhong Yao Za Zhi. 2012 Jul;37(13):1890-3.
To investigate the safety of different level of tween 80 by comparing the degree of pseudoanaphylactoid reactions (PR) induced by medicinal tween 80 and injectable tween 80.
The analysis of vascular permeability of the mice ears: ICR mouse were divided into different test groups, the mice were intravenously injected with solutions of medicinal tween 80 and injectable tween 80 with 0.2%, 1% and 5% concentration, positive control Compound 48/80 and 5% glucose injection. All test substances were mixed with 0.4% Evans blue. The reaction and vascular permeability of the ears were observed and measured 30 min after injection. The analysis of vascular permeability of the rat's skin: the rats were intravenous injected with 0. 6% Evans blue normal saline solution first, 10 minutes later, the same substances were intradermal administrated into the back of rats. The rats were sacrificed and the diameter of locus ceruleus and the content of Evans blue leak out were measured 20 min after injection.
Medicinal tween 80 and injectable tween 80 with 5% concentration caused obvious vascular hyper permeability in ICR mice, but the degree of vascular hyperpermeability caused by injectable tween 80 was lighter than by medicinal tween 80. Other tween 80 didn't cause obvious vascular hyper permeability in the ears of mouse. The solution of different concentration of tween 80 caused obvious locus ceruleus reaction in rat's back. As for the content Evans blue leak out, there was no statistical significance between each group except positive control Compound 48/80 group.
Tween 80 can cause obvious vascular hyper permeability and the effect is dose dependent, which indicated that tween 80 can cause PR. On the other hand, injectable tween 80 is more security than medicinal tween 80, the dosage of tween 80 should be still controlled strictly so that to decrease the incidence of PR.
通过比较药用吐温80和注射用吐温80诱导的类过敏反应（PR）程度，研究不同浓度吐温80的安全性。
小鼠耳部血管通透性分析：将ICR小鼠分为不同试验组，分别静脉注射浓度为0.2%、1%和5%的药用吐温80溶液、注射用吐温80溶液、阳性对照物48/80及5%葡萄糖注射液。所有受试物均与0.4%伊文思蓝混合。注射30分钟后观察并测量耳部的反应及血管通透性。大鼠皮肤血管通透性分析：先给大鼠静脉注射0.6%伊文思蓝生理盐水溶液，10分钟后，将相同受试物皮内注射到大鼠背部。注射20分钟后处死大鼠，测量蓝斑直径及伊文思蓝渗出量。
5%浓度的药用吐温80和注射用吐温80在ICR小鼠中引起明显的血管通透性增高，但注射用吐温80引起的血管通透性增高程度比药用吐温80轻。其他浓度的吐温80在小鼠耳部未引起明显的血管通透性增高。不同浓度吐温80溶液在大鼠背部引起明显的蓝斑反应。至于伊文思蓝渗出量，除阳性对照物48/80组外，各组间无统计学差异。
吐温80可引起明显的血管通透性增高，且作用呈剂量依赖性，提示吐温80可引发PR。另一方面，注射用吐温80比药用吐温80更安全，仍应严格控制吐温80的用量，以降低PR的发生率。
