Cutaneous Leishmaniasis (CL) is the most common type of Leishmaniasis, which annually affects 1.5 million people worldwide. About 90% of cases are reported from countries such as Iran, Afghanistan, Pakistan, Iraq, and Saudi Arabia. The purpose of the present study was to fabricate transdermal patches of Nigella sativa (NS), characterize, and to check its in vitro/in vivo anti-Lieshmanial activity. Hydroalcoholic extract was analyzed for preliminary phytochemicals. Five formulations of transdermal patches (NS1, NS2, NS3, NS4, and NS5) were prepared by solvent evaporation method. The optimized formulation NS5 was characterized for Fourier transform-infrared spectroscopy (FTIR), smoothness, brittleness, clarity, thickness, folding endurance, uniformity of weight, percent moisture content, in vitro drug release, release kinetics, ex vivo drug permeation, and in vitro anti-Lieshmanial activity. In vivo anti-Lieshmanial activity was assessed in 30 patients (n = 30) suffering from CL. The FTIR studies showed no incompatibility among the active extract and polymers. In vitro anti-Lieshmanial assay was 194.6% ± 1.88% as compared with standard drug (p > 0.05) and in vivo anti-Lieshmanial activity was 75%. The drug release after 24 h was 87.0% ± 0.94% in NS5, which showed non-Fickian diffusion mechanism while drug permeation across rabbit skin after 24 h was up to 80.0% ± 0.91%. The results concluded that problems related to the parenteral medications used for Lieshmanial treatment can be managed by applying extract of NS seeds in the form of transdermal patch.

中文翻译：

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对黑种草透皮贴剂潜在的利什曼杀灭活性的新见解：配方开发、物理表征和体外/体内测定

皮肤利什曼病 (CL) 是最常见的利什曼病类型，每年影响全球 150 万人。大约 90% 的病例来自伊朗、阿富汗、巴基斯坦、伊拉克和沙特阿拉伯等国家。本研究的目的是制造黑种草 (NS) 的透皮贴剂，表征并检查其体外/体内抗Lieshmanial活动。对水醇提取物进行初步植物化学分析。采用溶剂蒸发法制备了五种透皮贴剂（NS1、NS2、NS3、NS4 和 NS5）。优化配方 NS5 的特征在于傅立叶变换红外光谱 (FTIR)、光滑度、脆性、透明度、厚度、耐折叠性、重量均匀性、水分含量百分比、体外药物释放、释放动力学、离体药物渗透和体外抗Lieshmanial活性。 在30 名患有 CL的患者 ( n = 30) 中评估了体内抗 Lieshmanial活性。FTIR 研究表明活性提取物和聚合物之间没有不相容性。与标准药物相比，体外抗 Lieshmanial测定为 194.6% ± 1.88% ( p > 0.05)，体内抗 Lieshmanial活性为 75%。NS5中24 h后药物释放率为87.0%±0.94%，表现出非Fickian扩散机制，而24 h后药物在兔皮肤上的渗透率高达80.0%±0.91%。结果得出结论，与用于利什曼原虫治疗的肠外药物有关的问题可以通过以透皮贴剂的形式应用 NS 种子提取物来解决。