新型坤净栓的毒理学研究

Toxicological studies of new Kunjing suppository

为研究中药复方药新型坤净栓对小鼠和大鼠的毒性作用,采用大鼠阴道给药和小鼠ig给药两种方法,给药后连续观察14 d;长期毒性研究连续大鼠阴道给药12周及停药后2周,检测大鼠的生长发育、血液学及血液生化学等方面各项相关指标.急性毒性试验结果和对照组比较,新型坤净栓对大鼠和小鼠的体重、外观、器官组织均没有影响;长期毒性试验结果与空白对照组比较,大鼠脏器系数中新型坤净栓中剂量组和基质组有显著性差异,大鼠血象指标中阳性组的血红蛋白和红细胞计数有显著性差异,大鼠生化指标中阳性组的GLU、AKP、BUN,低剂量组CHO,基质组AKP、BUN均有显著性差异,其他指标均无显著性差异;与阳性对照组比较,新型坤净栓各组的血红蛋白和红细胞计数,GLU和AKP等存在显著性差异;肉眼观察给药组大鼠主要脏器未见明显异常,病理切片检查所观察到的个别动物组织病变均属于动物的自发病变.新型坤净栓对小鼠ig给药及大鼠阴道给药均未见明显毒性,初步表明新型坤净栓较安全.

To study toxic effects of Chinese herbal compound new Kunjing suppository on mouse and mice,two methods about acute toxicity experiment were established. One is mouse vaginal administration,and the other is mice ig administration. The continuous observation was performed for 14 days after drug administration. Long- term toxicity experiment took mouse vaginal drug delivery which lasted 12 weeks as model,then testing their related indicators of growth,haematology and blood biochemistry. The results of acute toxicity experiment showed that there was little difference between drug administration groups and blank group of their weight,appearance and organ tissue. Compared with blank group,the results of long- term toxicity experiment were as followed. The organ indexes of new Kunjing suppository medium dosage group and matrix group showed significant differences; hemogram indexes HGB and RBC of positive group showed significant differences; biochemical indexes GLU,AKP,BUN of positive group,CHO of low dosage group,AKP and BUN of matrix group both showed significant differences,other indicators showed no significant differences.Compared with positive group,HGB,RBC,GLU and AKP of each dosage of new Kunjing suppository showed significant differences. No obvious anomalies of the main organs of drug administration mouse were bserved by visual inspection. According to pathological biopsy,some individual animal tissue lesions belong to spontaneous lesions. New Kunjing suppository showed little toxicity to mouse vaginal drug delivery and mice gastric drug delivery,and preliminary indicated that new Kunjing suppository was safe.