利福昔明乳房注入剂的局部刺激性与过敏性试验研究

Study on Local Irritation and Allergy Tests of Rifaximin Breast Implants

为了科学、客观地评价干乳期利福昔明乳房注入剂在奶牛临床上应用的安全性,根据相关技术指导原则,分别进行家兔的皮肤刺激性试验、阴道刺激性试验及豚鼠主动皮肤过敏性试验,试验结果显示,利福昔明乳房注入剂给药部位的皮肤和生理盐水对照组都没有出现红斑和水肿,刺激强度的评分为0分;阴道刺激试验的试验组和对照组的阴道粘膜没有出现明显的白细胞浸润、充血和水肿现象,阴道粘膜刺激指数为0.25;在皮肤过敏性试验中,给药组动物皮肤未见红斑与水肿,各时间的皮肤刺激反应积分为0。因此,利福昔明乳房注入剂对家兔的皮肤和阴道无刺激性;对豚鼠不产生明显的皮肤过敏性反应。

In order to scientifically and objectively evaluate the safety of cows clinical application of rifaximin breast implants in the dry period, referring to the relevant technical specifications, rabbit skin irritation test, vaginal mucous membrane irritation test and guinea pig skin allergy test respectively was studied. The results showed that erythema and edema was not been found on rifaximin breast implants administration site skin and saline control site skin, and score of 0 points. In the vaginal mucous membrane irritation test, leukocyte infiltration, hyperemia and edema was not been found obviously in vaginal mucosa of test group and control group,vaginal mucous membrane irritation index was 0.25. In the skin allergy test, erythema and edema was not been found on test group,skin irritation in each time integral was 0. So, rifaximin breast implants had no irritation on rabbit skin and vaginal mucous membrane; guinea pigs do not produce significant allergic skin reaction after administration.