艾纳香口腔护理液安全性评价研究

摘要

The oral mucosa irritation and oral mucosa acute toxicity for Blumea mouthwash were tested on SD rat; allergy tests was carried on white guinea pig, and acute toxicity was tested on KM mice through lavage administration. Oral mucosa, applied skin, changes in weight, systemic toxicity reaction and death situation were observed after the treatment. During the oral mucosa irritation test, there was no abnormal oral mucosa tissue observed in the histopathological sections of SD rat. During the allergy tests, the results showed that Blumea mouthwash had no allergic response on skin treatment of white guinea pig. During the acute toxicity test, all rats were found well tolerated. And its maximum lethal dose (MLD) in mice was 288 mg/kg, which was equal to about 1 200 times of the adult dosage. Besides, there was no death and obvious toxic effects occurred in these animals. It meant that the Blumea mouthwash had no oral mucosa irritation and sensitization, no significant acute toxicity. It may be used as asafety clinical oral care liquid topically.%选用SD大鼠进行口腔黏膜刺激性试验、口腔及黏膜用药急性毒性试验；选用白色豚鼠进行过敏试验；选用昆明种小鼠进行灌胃给药急性毒性试验，观察给药后动物口腔黏膜、受药皮肤、体重变化、全身毒性反应情况及死亡只数。艾纳香口腔护理液在口腔黏膜刺激性试验中，未发现SD大鼠口腔黏膜组织异常；在过敏试验中，白色豚鼠皮肤用药未引起过敏反应；在急性毒性试验中，大鼠的耐受性良好；小鼠灌胃时测得的最大给药量(MLD)为288 mg/kg，相对于成人给药量的1200倍。上述动物均未见死亡和明显毒性反应。以上试验说明艾纳香口腔护理液无口腔黏膜刺激性和致敏性，无明显急性毒性反应，提示其作为口腔外用护理液临床用药安全。