舒康凝胶剂阴道用药对大鼠的毒性作用研究

在以累计剂量为１０．９５ｇ生药／ｋｇ（６０ｋｇ人按体重计用药量的１０９．５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４．３８ｇ生药／ｋｇ（６０ｋｇ人按体重计用药量的４３．８倍）、低剂量为２．１９ｇ／ｋｇ，受试大鼠体重增长一

Study on Toxicity of Shukangning Gel by Vaginal Administration in Rat

This experiment showed that Shukangning gel had no obvious side|effects, no death on the female rats and no signs of congestion, oedema and tissue pathological changes on the vaginal mucosa in acute toxicity by vaginal administration with a total dose of 10.95g crude drug per kg, which was 109.5 times of a clinical dose per 60kg. Whereas single and multiple administration of the drug did not significantly stimulate the vaginal mucosa. There was no significant difference in the body weight, index of hematology and major blood biochemistry, relative organ weight and major organ pathological examination between the control and drug treated groups in long term toxicity with a high dosage of 4.38g per kg which was 43.8 times of a clinical dose per 60kg and low dose of 2.19g per kg. The test had been continued for 3 weeks which was as 3 times long as that of a clinical use period.