中国兽药杂志2025，Vol.59Issue(9)：44-52,9.DOI:10.11751/ISSN.1002-1280.2025.9.07
黄体酮阴道缓释剂的非临床安全性评价
Non-clinical Safety Evaluation of Progesterone Vaginal Sustained-release Suppositories
王开济 1姚珍珍 2陈舒怀 1韩善磊 1匡荣1
作者信息
- 1. 浙江省食品药品检验研究院(全省生物医药接触材料重点实验室),杭州 310052
- 2. 宁波三生生物科技股份有限公司,浙江 宁波 315000
- 折叠
摘要
Abstract
To evaluate the safety profile of progesterone vaginal sustained-release suppositories,vaginal irritation test and Buehler test(BT)in guinea pigs were implemented to assess mucosal irritancy and sensitization potential,respectively.Experimental animals were divided into groups receiving blank suppositories,the test substance,and a commercially available reference product for comparative analysis.The vaginal irritation study utilized female New Zealand White rabbits subjected to continuous intravaginal administration for 14 days with a minimum daily exposure of 4 hours.Histopathological examination was performed on vaginal and reproductive organs from 4 rabbits per group at 72 hours post-final administration,with remaining specimens(2 rabbits/group)analyzed following a 7-day recovery period.For the Buehler sensitization assessment,Hartley guinea pigs received epicutaneous applications of test substance extract(0.2 g/mL concentration)through standardized sensitization and challenge protocols,with subsequent monitoring of cutaneous hypersensitivity responses.Under the specified experimental conditions,progesterone vaginal sustained-release suppositories exhibited no detectable irritation in the vaginal mucosa of rabbits throughout the 14-day treatment.Furthermore,the absence of dermal sensitization in guinea pigs was confirmed at the tested extract concentration.These collective findings demonstrate favorable safety characteristics of the progesterone vaginal sustained-release suppositories in the evaluated models.关键词
黄体酮阴道缓释剂/非临床安全性评价/阴道刺激性试验/豚鼠Buehler试验(BT)Key words
progesterone vaginal sustained-release suppositories/non-clinical safety evaluation/vaginal irritation test/buehler guinea pig test(BT)分类
农业科技引用本文复制引用
王开济,姚珍珍,陈舒怀,韩善磊,匡荣..黄体酮阴道缓释剂的非临床安全性评价[J].中国兽药杂志,2025,59(9):44-52,9.
