乙酸阴道热敏凝胶剂对小型猪阴道黏膜的刺激性  

Vaginal irritation of acetic acid thermosensitive in situ gel in mini-pigs

作　　者：职瑞娜 田芳[1] 王玉柱[1] 黄超[1] 夏敏杰[1] 丁训城[1] 李卫华[1] 

机构地区：[1]国家计划生育药具重点实验室,上海市计划生育科学研究所,上海200032 [2]复旦大学公共卫生学院,上海200032

出　　处：《中国新药杂志》2014年第23期2798-2802,共5页Chinese Journal of New Drugs

基　　金：国家自然科学基金(81100459);国家科技支撑计划(2012BAI31B04;2012ZX10001007-009-003;2013ZX10001006-003-002);上海市人口和计划生育委员会(2012JG03)

摘　　要：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。Objective： To evaluate the vaginal irritation of acetic acid thermosensitive in situ gel （Acid- TISG） in mini-pigs. Methods： Nine female mini-pigs were randomly divided into three groups. Each pig was vaginally administrated with 5 mL of blank gel （ control）, Acid-TISG or commercial nonoxynol gel （ N-9 jelly）, once daily for 7 days. Cervicovaginal lavage （CVL） fluids were collected before administration, and 24 h and 72 h after the last administration. The number of inflammatory cells and neutrophilic granulocytes in the CVL was detected by flow cytometry. The difference between three groups was compared. Mini-pigs were sacrificed 72 h after the last ad- ministration. The vaginal tissues were observed. CD45 expression in the vaginal mucosa was semi-quantitated by immunohistochemical assay. Results： The number of inflammatory cells and neutrophilic granulocytes was signifi- cantly lower in Acid-TISG group than in N-9 jelly group （P 〈0. 001 ）. However, there was no significant difference between Acid-TISG gel and control groups （P 〉 0.05）. Compared to control group, CD45 expression in vaginal mucosa was not significantly different in Acid-TISG group （P 〉 0.05） , but significantly increased in N-9 jelly group （P 〈 0.05）. Conclusion： Vaginal irritation of Acid-TISG in min-pigs is mild. Acid-TISG has a good pros- pect as a topical contraceptive.

关 键 词：乙酸阴道热敏凝胶剂 小型猪 阴道灌流液 CD45 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]