摘要
目的 为确保临床用药的安全 ,对中药固齿缓释剂进行毒理学检测。方法 按新药的有关要求作如下试验 :①IRC小鼠最大耐受量 (MTD)试验。②Wistar大鼠慢性毒理学试验。③Wistar大鼠口腔黏膜毒性及刺激试验。④豚鼠皮肤过敏试验。结果 动物对该药物有很大的耐受性 ,MTD =2 6 6g kg体重 ,对动物的血常规及肝功、肾功和5个重要脏器均无明显影响 ,对皮肤和口腔黏膜无刺激及致敏作用。结论 该制剂可安全用于临床。
Objective To assure the safty of clinical application of new drug,and test the toxicology of periodontal traditional Chinese medicine Gu Chi sustained release preparation.Methods The following tests were done according to the requirements of developing new drugs.①The MTD (maximal tolerance dose )test on IRC rats.②The chronic toxicology test on Wistar rats.③The oral mucosa toxic and irritating tests on Wistar rats.④The skin allergic test on guinea pigs. Results The results showed that the animals had a good tolerance to this drug.The MTD was 266g/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 effects on skins and oral mucosa.Conclusion The clinical application of this agent is safe.
出处
《哈尔滨医科大学学报》
CAS
2003年第4期315-317,共3页
Journal of Harbin Medical University
基金
黑龙江省教育厅科学技术研究项目 ( 2 0 0 2 10 5 110 49)
关键词
牙周
中药
固齿缓释剂
毒理学
牙周炎
traditional Chinese drug
sustained release preparation
toxicology
periodontitis
rat
mouse
