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在以累计剂量为1095g生药/kg(60kg人按体重计用药量的1095倍)阴道用药的急性毒性试验中,大鼠未出现异常反应和死亡,未见阴道粘膜充血、水肿和明显病理改变;一次与多次用药均未见阴道粘膜充血、水肿和明显病理改变;在连续用药3周(为临床拟用药疗程1周的3倍)的长期毒性试验中,其高剂量为438g生药/kg(60kg人按体重计用药量的438倍)、低剂量为219g/kg,受试大鼠体重增长一致,未见不良反应,给药组与空白组的血液学、血液生化主要指标和脏器重量系数统计学对比无显著性差异(P>0.05),主要脏器无明显外观异常和病理改变
In an acute toxicity test with a cumulative dose of 1095 g crude drug/kg (1095 times the dose of 60 kg human body weight), no abnormal reaction and death occurred in the rat, and no congestion, edema and obvious pathological changes of the vaginal mucosa were observed. No vaginal mucosal hyperemia, edema, and obvious pathological changes were observed in one or more administrations; in the long-term toxicity test for 3 consecutive weeks (3 times of one week for the planned clinical medication), the high dose was 438 g crude drug/kg ( 60kg were 438 times of body weight, and low dose was 219g/kg. Body weight of the test rats increased in a consistent manner, no adverse reactions were observed, and hematology, blood biochemical indicators and organ weights of the administration group and the blank group were not significant. There was no statistically significant difference in the coefficients (P>0.05). There were no obvious appearance abnormalities and pathological changes in the main organs.