苦参凝胶对新西兰兔阴道黏膜的刺激反应及其安全性评价  

Experimental Study of “Ku Shen Gel”on the Irritation and Safety of Vaginal Mucosa in New Zealand Rabbits

作　　者：张飞 顾性初 罗金红[3] 陈凯[2] 蔡金娜 张杰[4] 

机构地区：[1]上海海天医药科技开发有限公司,上海200023 [2]美迪西普亚医药科技(上海)有限公司,上海201203 [3]上海市东方医院肿瘤血液科,上海200120 [4]上海中医药大学,上海201203

出　　处：《上海中医药大学学报》2015年第5期86-89,共4页Academic Journal of Shanghai University of Traditional Chinese Medicine

摘　　要：目的:观察苦参凝胶对兔阴道黏膜的刺激反应及其安全性。方法:将18只雌性新西兰兔根据体质量水平随机分为3组,分别为高剂量组、低剂量组和基质组。高剂量组予苦参凝胶2次/d,低剂量组予苦参凝胶1次/d,基质组予苦参凝胶基质1次/d,均连续阴道给药7 d,1 ml/次。观察各组动物的生存情况及生理生化指标与阴道黏膜刺激反应。结果:各组动物未见死亡,临床观察及大体解剖肉眼观察均未发现任何异常;苦参凝胶各剂量组动物的体质量、摄食量、血常规、凝血指标及血清生化指标等与同期基质组比较,差异均无统计学意义(P>0.05);组织病理学检查发现苦参凝胶对新西兰兔阴道黏膜无明显刺激反应。结论:苦参凝胶对新西兰兔阴道无明显刺激性,且无明显的生理生化毒副反应。Objective: To observe the vaginal mucosa irritation of'Ku Shen Gel'in rabbits and evaluate the safety of the drug. Methods: Eighteen female New Zealand rabbits were randomly assigned to high-dose Ku Shen Gel group,low-dose Ku Shen Gel group and stroma group. The'Ku Shen Gel'or stroma was delivered via the vaginal mucosa,1 m L every times,once every day in the low-dose group and the stroma group and twice every day in the high-dose group,for 7 days continuously. Each animal's survival circumstances and physiological and biochemical indicators and vaginal mucosa stimulation reactions were observed. Results: No obvious death and abnormal phenomenon was observed by clinical and gross anatomical observation in each group. There were no obvious changes between the Ku Shen Gel groups and the stroma group in animal weights,food consumption,routine blood indexes,coagulation index and serum biochemical indexes( P > 0. 05). No obvious vaginal mucosa irritation on New Zealand rabbits were observed by histopathological examination. Conclusion: 'Ku Shen Gel'had no obvious local vaginal mucosa irritation and physiological and biochemical toxicity on New Zealand rabbits.

关 键 词：苦参凝胶 新西兰兔 阴道刺激性 安全性 

分 类 号：R285.5[医药卫生—中药学]