复方苯佐卡因凝胶的局部毒性研究
Studies on topical toxicity of Benzocaine compound gel
作者：韦宝伟1 刘布鸣2 陈力力3 刘元1 姚树汉3
Author：Wei Baowei1, Liu Buming2, Chen Lili3, Liu Yuan1, Yao Shuhan3.
收稿日期：2010-11-14 年卷（期）页码：2012,39(1):10-11
期刊名称：国际口腔医学杂志
Journal Name：International Journal of Stomatology
关键字：苯佐卡因, 凝胶, 刺激性, 致敏性, 家兔, 豚鼠, 局部毒性,
Key words：Benzocaine, gel, irritation, sensitization, rabbit, guinea pig, topical toxicity,
基金项目：
中文摘要
目的 评价复方苯佐卡因凝胶的局部刺激性和致敏性。方法 依照国家食品药品监督管理局《化学药物刺激性、过敏性和溶血性研究技术指导原则》（以下简称指导原则），采用大鼠口腔黏膜刺激性实验法、兔眼刺激性实验法以及豚鼠皮肤致敏实验法。结果 复方苯佐卡因凝胶给大鼠口腔正常黏膜连续涂药3 次，相当于3 g·kg-1，均无刺激和毒性反应；一次性按每只0.1 g 给兔眼结膜涂药，亦未出现刺激性反应；给每只豚鼠皮肤0.2 g 致敏接触和激发接触，均无过敏反应发生。结论 复方苯佐卡因凝胶对口腔黏膜无刺激性，对皮肤也没有致敏性。
英文摘要
Objective To evaluate the topical irritation and sensitization of Benzocaine compound gel. Methods Irritation tests of rat oral mucosa, rabbit eyes, and skin hypersensitivity tests in guinea pigs were used, in accordance with the‘Guidance for Irritation, Sensitization and Hemolytic Tests for Chemicals’by the State Food and Drug Administration. Results By application of 3 g·kg-1 to rat oral mucosa, or 0.1 g to rabbit eyes, Benzocaine compound gel exhibited no irritation or other toxicity. No sensitization was found when 0.2 g of the gel was applied to the guinea pig skin. Conclusion Benzocaine compound gel is not irritative to oral mucosa, and does not cause skin allergy.
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