复方妇科洗液安全性评价实验研究  

Safety evaluation experiment of compound gynecological lotion

作　　者：江杨帆[1] 辛及娣 刁慧敏[1] 戴陈伟[1] 李睿[1] 王超[1] JIANG Yang-fan,XIN Ji-di,DIAO Hui-min,DAI Chen-wei,LI Rui,WANG Chao(Anhui Academy of Medical Sciences, Hefei 230061, Anhui, Chin)

机构地区：[1]安徽省医学科学研究院,安徽合肥230061

出　　处：《安徽预防医学杂志》2018年第2期82-85,共4页Anhui Journal of Preventive Medicine

摘　　要：目的通过复方妇科洗液豚鼠皮肤刺激试验、皮肤过敏试验及家兔阴道粘膜刺激试验,对其安全性进行评价。方法皮肤刺激试验选取皮肤健康完好豚鼠3只,每只豚鼠一侧背部皮肤均匀涂抹复方妇科洗液,另一侧皮肤为空白对照,连续涂抹皮肤14 d,在每次涂抹后24 h观察皮肤局部反应并记录结果;豚鼠过敏试验选取48只豚鼠,随机分为给药组、阴性和阳性对照组,每组16只,雌雄各半,各组给相应药物进行诱导和激发处理后,观察皮肤是否出现过敏反应并计算致敏率;家兔阴道粘膜刺激试验选取成年雌性家兔6只,分为给药组和生理盐水阴性对照组,每组3只,连续给药5 d,末次给药24 h后采用气栓法处死动物取出完整阴道组织进行病理学制片,并于光学显微镜下观察家兔阴道粘膜的组织形态。以上试验均按相关标准对刺激强度进行打分并按评分标准进行评定。结果皮肤刺激试验结果刺激指数为0;皮肤过敏试验均未观察到过敏反应,致敏率为0%;阴道粘膜刺激试验中肉眼观察未见明显异常,显微镜观察仅个别动物组织出现轻度充血、水肿,其它未见明显异常病理改变,阴道粘膜刺激指数为0.34。以上均按评分标准评价为无刺激。结论妇科洗液无皮肤刺激,无致敏性,对家兔阴道粘膜无刺激。Objective To evaluate the safety of compound gynecological lotion by using skin irritation test,skin allergy test and vaginal mucosa irritation test. Methods Skin irritation test was used to select 3 healthy skin guinea pigs,the skin of each guinea pig was evenly smeared with compound gynecologic lotion,and the other side of the skin was blank,skin smear was applied for 14 d,and observed the skin after 24 h of each skin smear. Skin allergy test was used to select 48 healthy skin guinea pigs,which were divided into drug group and two control groups,each group had 16 pigs,half male and half female,then observed the skin and calculated the sensitization rate after the corresponding drug induction and irritation.Vaginal mucosa irritation test was used to select 6 adult female rabbits,which were divided into drug group and control group,each group had 3 rabbits. The rabbit vaginal tissues were taken for pathological observation after continuous administration of 5 d and the last dose of 24 h. The above tests were all graded and evaluated according to the relevant standards.Results SI of the skin irritation was 0. No anaphylaxis was found in the skin allergy test,and the sensitization rate was 0%. There was no significant abnormality in naked eye observation in vaginal mucosa irritation test,microscopic examination showed only slight congestion and edema in individual animal tissues,no significant abnormal pathological changes were found in the other animals,and SI of vaginal mucosal irritation was 0. 34. Conclusion Compound gynecological lotion had no skin irritation,no anaphylaxis,and no irritation to the vaginal mucosa of the rabbit.

关 键 词：复方妇科洗液 皮肤刺激 皮肤过敏 阴道粘膜刺激 安全性评价 毒理试验 实验研究 

分 类 号：R285[医药卫生—中药学]