复方奥硝唑甲磺酸培氟沙星缓释牙栓毒理学实验研究

Toxicological experiment study of Compound Ornidazole and Pefloxacinmesylat Sustained-release Periodontal Suppository

目的了解动物对复方奥硝唑甲磺酸培氟沙星缓释牙栓的毒理学反应,为开发应用牙周病治疗新药提供试验依据。方法按新药的有关要求进行如下试验:(1)昆明小鼠最大耐受量(MTD)试验;(2)SD大鼠慢性毒理学试验;(3)豚鼠皮肤过敏试验;(4)SD大鼠牙周黏膜毒性及刺激试验;(5)新西兰兔眼部刺激试验。结果动物MTD为8．4g／kg;该药物对动物的肝功、肾功、血常规及5个重要脏器均无明显影响;对皮肤和牙周黏膜无刺激;该药眼刺激实验平均得分≤3分,在用药48h后全部消失,为可逆变化,属无刺激。结论动物对该药物有很大的耐受性,毒性低,可以进一步深入临床研究。

Objective To assure the animals＇ response to the toxicology of Compound Ornidazole and Pefloxacinmesylat Sustained-release Periodontal Suppository, and to provide experimental basis for development and application of the new drug for the therapy of periodontosis. Methods The following tests were done according to the requirements of developing new drugs. （1）The maximal tolerance dose（MTD） test on K unming rats. （2）The chronic toxicology test on standard rats. （3）The skin allergic test on guinea pigs. （4）The oral mucosa toxic and irritating tests on SD rats. （5）The eyes irritating tests on rabbits. Results MTD was 8.4g/kg body weight. It had no evident impact on routine blood test, liver function test, kidney function test and 5 important organs of the animal, and it also had no irritating and allergic effect on skins and oral mucosa. The average grade in the eyes was≤3, but it rapidly disappeared in 48h. which meant that there were no irritating effects. Conclusion Animals have good tolerance to the new drug with low toxicity, which is safe for clinical research.