温敏型阴道酸缓冲原位凝胶的制备与质量评价  

Preparation and Quality Evaluation of Thermosensitive Vaginal Acid Buffer in-situ Gel

作　　者：徐伟娜 杨清华 王勤 王传栋 刘林 颜红 

机构地区：[1]山东省药学科学院,山东省医用高分子材料重点实验室,山东济南250101 [2]山东福瑞达医药集团公司,山东省黏膜与皮肤给药技术重点实验室,山东济南250101

出　　处：《生物医学工程研究》2017年第2期164-167,共4页Journal Of Biomedical Engineering Research

基　　金：山东省科技计划项目(2007GG20002013)

摘　　要：制备了一种具有温度敏感特性的凝胶体系,室温下为液体,体温时变为半固体凝胶。这种液体—凝胶转变的响应速率迅速,使其易于铺展、附着在阴道壁和子宫颈上,与阴道壁及子宫颈充分接触,同时便于在阴道内滞留。酸缓冲体系的建立,可保持阴道的pH值在3.5~4.5之间,由此恢复和维持正常的阴道酸性环境。家兔阴道给药无明显的全身及局部的毒性反应,家兔阴道也无刺激性反应。本品对多数细菌具有抑制作用,对皮肤无致敏作用,同时还有一定的杀精子作用。To prepare a thermosensitive gel,which is liquid in room temperature and undergoes a phase transition to bioadhesive gel at body temperature. The transition is rapid that make it is easy to spread out and attatch to vaginal wall and cervix uterus,and help the vaginal wall and cervix uterus make contact with the gel. The existence of acid buffer system can maintain pH between 3. 5 to 4. 5 in vaginal wall,thus acid ambient can be recoverd. The in-situ vaginal gels administered intravaginally had no significant systemic and local toxicity. And it is not irritative to vaginal in rabit. This product has no sensitization to skin. The gel has bacteriostasis and spermatocidal effects.

关 键 词：原位凝胶 酸缓冲体系 阴道滞留 阴道刺激性 抑菌 

分 类 号：R318[医药卫生—生物医学工程]