不同周龄SD大鼠外耳道腺结构与药物临床前安全性评价

Histology of the Zymbal's Gland in Different Aged SD Rats on Safety Evaluation of Preclinical Drugs

目的:探讨大鼠外耳道腺的正常组织结构及年龄组间,雌雄动物间有无差异,以期为药物评价过程中药物对耳腺影响的评价提供客观的依据。方法:将20只同龄SD大鼠随即分为A和B两组,每组均雌雄各半,分别与12周和17周龄处死,取外耳道腺进行病理学分析。观察外耳道腺在不同年龄组间、雌雄组间有无区别。结果:A组动物雌雄组间外耳道腺的组织结构无明显差异。B组动物雌雄动物间外耳道腺的组织结构无明显差异。A组雌性动物与B组雌性动物间外耳道腺的组织结构无明显差异。A组雄性动物与B组雄性动物间外耳道腺的组织结构无明显差异。结论:SD大鼠外耳道腺的组织结构在雌雄动物间及年龄在12周及17周间无明显差异,因此在进行药物对耳腺的影响的评价过程中12周龄和17周龄的受试大鼠所得到的结果应具备可比性。

Objective： To explore the normal histology structure of the Zymbal＇ s gland of SD rats in different age and different sex, in order to provide objective evidences for safety evaluation of drugs that may affect the Zymbal＇s glands. Methods： Twenty same aged SD rats （8 weeks） were divided into two groups （Group A and Group B）. In each group, the numbers of females and males were equal. Rats from group A were exsanguinated, and necropsied at the 12th week of age and from group B were exsanguinated, and necropsied at the 17th week. The histopathological changes of the zymbal gland between different ages and different sexes were observed. Results： There were no histological differences between the male and female rats in group A, no histological differences between the male and female rats in group B; there were no histological differences in either sexes between group A and group B. Conclusion： Since there are no histological structure differences between the male and female, between the 12-week old rats and the 17-week old rats, the 12-week old rats have the comparative value with the 17-week old rats in safety evaluation of drugs that may affect the Zymbal＇s gland.