Alexander N J, Fulgham D L, Zatuchni B, Zaneveld L J
Fertil Steril. 1981 Oct;36(4):516-20.
An in vitro penetration test employing bovine cervical mucosa to evaluate vaginal contraceptives is presented. Its usefulness for the evaluation of the potency of a formulation in preventing sperm penetration was assessed by comparison of five commercially available preparations, with the use of both human and primate spermatozoa. The results were compared with those obtained with a spermicidal test (Sander-Cramer method) and in vivo with the use of the primate Macaca arctoides. Analysis of the two in vitro tests and the one in vivo test showed a significant degree of concurrence. The cervical mucus test much more closely reflected in vivo results than the Sander-Cramer test. A recommendation is made regarding the type and order of in vitro and in vivo methods to be used for the development and/or testing of new formulations.
本文介绍了一种采用牛宫颈黏膜评估阴道避孕药的体外渗透试验。通过比较五种市售制剂,使用人类和灵长类动物精子,评估了该试验在评估制剂预防精子穿透效力方面的实用性。将结果与杀精试验(桑德 - 克莱默法)的结果以及使用食蟹猴进行的体内试验结果进行了比较。对两项体外试验和一项体内试验的分析表明,它们之间存在显著程度的一致性。宫颈黏液试验比桑德 - 克莱默试验更能准确反映体内结果。针对新制剂研发和/或测试中体外和体内方法的类型及顺序提出了建议。