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目的了解重组溶葡萄球菌酶的皮肤刺激性、阴道黏膜刺激性和产生皮肤变态反应的可能性及其强度。方法参照相关技术规范中的皮肤刺激试验、阴道黏膜刺激试验和皮肤变态反应试验方法进行。结果皮肤刺激试验受试皮肤的最高皮肤刺激指数为0;阴道黏膜刺激试验染毒组和对照组的阴道黏膜未见明显白细胞浸润、充血和水肿,阴道黏膜刺激指数为0.25;皮肤变态反应试验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零。结论重组溶葡萄球菌酶对兔皮肤刺激强度为无刺激性,对大鼠、兔一次阴道黏膜刺激强度为无刺激性,致敏强度为未见皮肤变态反应。
Objective To understand the skin irritation of recombinant lysostaphin, the irritability of vaginal mucosa and the possibility of skin allergy and its intensity. Methods with reference to the relevant technical specifications of the skin irritation test, vaginal mucosal irritation test and skin allergy test method. Results Skin irritation test skin highest skin irritation index was 0; vaginal mucosal irritation test exposure groups and the control group of vaginal mucosa showed no significant leukocyte infiltration, congestion and edema, vaginal mucosal irritation index was 0.25; skin allergy test group Animal skin no erythema and edema, skin irritation response time zero. Conclusion Recombinant lysostaphin has no irritation to rabbit skin irritation, no stimulant to vaginal mucosa in rats and rabbits, and no allergic skin sensitization.