Irritation test and endometrial transformation experiment of progesterone gel on rabbits after vaginal delivery

WANG Mei; HOU Yan-xia; CHANG Zhan-ying; HE Bing; ZHOU Xue-feng

Abstract：[ABSTRACT]Objective: To study vaginal irritation and effect on the lining of the uterus after vaginal delivered progesterone gel, and investigate the practicability of progesterone gel preparation.Methods: A total of 20 female rabbits were randomly divided into ifve groups: blank control group, blank matrix group, low dose group, middle dose group, and high dose group. Then the irritation of progesterone vaginal gel was studied after a single dose and multiple doses. The results were scored according to vaginal irritation grading standard tables and classiifcation criteria for vaginal irritation after observation. Furthermore, initial pharmacodynamics of progesterone gel was studied. The vagina and uterus of every rabbit was detected as well as the results were measured by transforming activity of each rabbit.Results: Compared with the blank control group, after a single dose and multiple doses, the rabbits in each group showed no obvious erythema and exudate. Biopsy results showed that there was no significant difference between rabbits in each group. In the initial pharmacodynamical study, the Mcphail indexes in blank matrix group, low, middle, high dose group and positive control group were (0.25 ± 0.46), (1.00 ± 0.61), (1.75 ± 0.50), (2.25 ± 0.50), (3.20 ± 0.27) respectively after 23 d treatments. Uterine pathological results showed the uterus changes from the proliferative phase to the secretory phase were all observed in the low, middle and high dose group.Conclusion:No significant vaginal and uterus irritation was observed in rabbits after vaginal delivery of progesterone gel with single or multiple doses. Furthermore, progesterone gel has certain progesterone activity, which shows that this formulation is feasible.