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目的:评价乙酸阴道热敏凝胶剂(Acid-TISG)对小型猪阴道黏膜的刺激性。方法:将9只雌性小型猪随机分为空白胶组、Acid-TISG组和市售壬苯醇醚凝胶(N-9 jelly)组,阴道给予5 m L凝胶,qd,连续给药7 d,在给药前和末次给药后的24,72 h,收集阴道灌流液(CVL),流式细胞仪计数炎性细胞和中性粒细胞数目,比较不同给药组之间的差别;末次给药72 h后处死小型猪,取阴道组织,免疫组化法检测阴道黏膜内CD45的表达。结果:Acid-TISG组CVL液中炎性细胞、中性粒细胞数目明显低于N-9 jelly组(P<0.001),与空白胶没有明显差异(P>0.05)。与空白胶组相比,Acid-TISG组的阴道黏膜CD45表达无显著性差异(P>0.05),N-9 jelly组CD45表达显著增加(P<0.05)。结论:乙酸阴道热敏凝胶剂对小型猪阴道黏膜刺激性较小,作为外用避孕药具有一定的应用前景。
PURPOSE: To evaluate the irritation of vaginal mucosa in Minipig by Acid-TISG. Methods: Nine female miniature pigs were randomly divided into blank gel group, Acid-TISG group and commercial N-9 jelly group. Vaginal administration of 5 mL gel, qd, continuous administration of 7 d, Vaginal perfusion fluid (CVL) was collected 24 and 72 h before and after the last administration, the number of inflammatory cells and neutrophils were counted by flow cytometry, and the differences between different administration groups were compared; Small pigs were killed 72 hours after the last administration, vaginal tissues were taken and the expression of CD45 in vaginal mucosa was detected by immunohistochemistry. Results: The number of inflammatory cells and neutrophils in CVL fluid of Acid-TISG group was significantly lower than that of N-9 jelly group (P <0.001), and there was no significant difference between the two groups (P> 0.05). The expression of CD45 in Acid-TISG group was not significantly different from that in the blank group (P> 0.05), while the expression of CD45 in N-9 jelly group was significantly increased (P <0.05). CONCLUSION: Acetic acid vaginal thermosensitive gels are less irritating to the vaginal mucosa in miniature pigs and have potential applications as topical contraceptives.