Dhondt Marijke M M, Adriaens Els, Remon Jean-Paul
Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat, Ghent, Belgium.
Sex Transm Dis. 2004 Apr;31(4):229-35. doi: 10.1097/01.olq.0000118422.62336.fa.
Frequent use of some vaginal formulations can induce mucosal irritation. Therefore, it is important to evaluate their vaginal tolerance.
The goal of this study was to optimize the mucosal irritation test using slugs for the evaluation of the local tolerance of vaginal gels and investigate the relevance of the test.
The irritation potential of the gels was assessed by the amount of mucus produced during a repeated 30-minute contact period. Membrane damage was estimated from the release of proteins and enzymes. After optimization of the procedure, the local tolerance of several vaginal gels was evaluated.
Hydroxyethyl cellulose gel induced no irritation, because the mucus production and the protein release were low and no enzyme release was detected. Replens and K-Y jelly resulted in an increased mucus production; however, no increased protein and no enzyme release were detected. The nonoxynol-9-containing gels Protectaid, Advantage S, and Conceptrol caused a higher mucus production and an increased protein release and/or enzyme release, indicating severe irritation.
The mucosal irritation test using slugs can be used for local tolerance testing of vaginal formulations.
频繁使用某些阴道制剂可引起黏膜刺激。因此，评估它们的阴道耐受性很重要。
本研究的目的是优化使用蛞蝓的黏膜刺激试验，以评估阴道凝胶的局部耐受性，并研究该试验的相关性。
通过在重复的30分钟接触期内产生的黏液量评估凝胶的刺激潜力。根据蛋白质和酶的释放估计膜损伤。在优化程序后，评估了几种阴道凝胶的局部耐受性。
羟乙基纤维素凝胶未引起刺激，因为黏液产生和蛋白质释放量低，且未检测到酶释放。Replens和K-Y润滑剂导致黏液产生增加；然而，未检测到蛋白质增加和酶释放。含壬苯醇醚-9的凝胶Protectaid、Advantage S和Conceptrol引起更高的黏液产生以及蛋白质释放增加和/或酶释放增加，表明有严重刺激。
使用蛞蝓的黏膜刺激试验可用于阴道制剂的局部耐受性测试。
