Shimamura Tsuyoshi, Hasegawa Nami, Kubota Nobuo
R&D Laboratories, POLA PHARMA INC.
Med Mycol J. 2016;57(1):J13-8. doi: 10.3314/mmj.57.J13.
We evaluated luliconazole nail solution, originally generated formulation, for the topical treatment of onychomycosis by two infection models. First, a suspension of Trichophyton mentagrophytes was dropped onto the ventral layer of human nail plate and these nails were set in Franz diffusion cells. After 9-day culture, luliconazole nail solutions (1, 3, and 5%) were applied to the dorsal surface of the nails once a day for 7 days. After application, fungal viability was assessed by measuring the ATP contents of the samples. The dose-dependent efficacy was confirmed, with 3% and 5% luliconazole nail solutions producing significantly lower ATP levels at 7-day treatment. When 3% and 5% luliconazole nail solutions were evaluated in a rabbit model of onychomycosis, both concentrations completely inhibited the recovery of fungi on culture after 4-week treatment. We therefore think these results indicate that 5% luliconazole nail solution is sufficiently potent for treatment of onychomycosis.
我们通过两种感染模型评估了最初研发的卢立康唑指甲溶液用于甲癣的局部治疗效果。首先,将须癣毛癣菌悬液滴在人指甲板的腹侧层,然后将这些指甲置于Franz扩散池中。培养9天后,每天一次将卢立康唑指甲溶液(1%、3%和5%)涂抹于指甲背侧,持续7天。涂抹后,通过测量样品中的ATP含量评估真菌活力。证实了剂量依赖性疗效,在7天治疗时,3%和5%的卢立康唑指甲溶液产生的ATP水平显著更低。当在兔甲癣模型中评估3%和5%的卢立康唑指甲溶液时,两种浓度在4周治疗后均完全抑制了培养物中真菌的恢复。因此,我们认为这些结果表明5%的卢立康唑指甲溶液对治疗甲癣具有足够的效力。