两性霉素B纳米脂质体制剂（西娜两性霉素）在动物模型中作为皮肤利什曼病治疗候选药物的安全性评价
Safety Evaluation of Nano-Liposomal Formulation of Amphotericin B (Sina Ampholeish) in Animal Model as a Candidate for Treatment of Cutaneous Leishmaniasis.
作者信息
Eskandari Seyed Ebrahim, Firooz Alireza, Nassiri-Kashani Mansour, Jaafari Mahmoud Reza, Javadi Amir, Miramin-Mohammadi Akram, Valian-Keshavarz Hossein, Khamesipour Ali
机构信息
Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran University of Medical Sciences, Tehran, Iran.
Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
出版信息
J Arthropod Borne Dis. 2018 Sep 30;12(3):269-275. eCollection 2018 Sep.
BACKGROUND
Development of a topical treatment for cutaneous leishmaniasis (CL) is an important step in the improvement of lesion management. Amphotericin B (AmB) is effective against species but it is toxic, a Nano-liposomal form of AmB with a size of about 100nm (Lip-AmB) was developed and showed to be effective against , and and against in animal model. This study was designed to check the irritancy Draize test in rabbits and was completed in the Center for Research and Training in Skin Diseases and Leprosy, TUMS, in 2012.
METHODS
Twenty rabbits in 3 steps were housed individually with artificial lighting (12/12h light/dark). SinaAmpholeish cream or empty liposomes (prepared under GMP condition at Minoo Company, Tehran, Iran), was applied on a gauze patch and the patches were placed on the designated sites of the skin in the back of the rabbits. At 48 and 72h later, the erythema and oedema were checked, scored and recorded.
RESULTS
The erythema score in rabbits was 0.83+0.41 for the SinaAmpholeish and 0.5+0.55 for empty liposomes (P= 0.16). The average score for oedema was 0.67+0.52 for SinaAmpholeish and 0.33+0.52 for empty liposomes (P= 0.16).
CONCLUSION
Based on skin irritancy reactions the topical formulation of SinaAmpholeish is safe and could be further checked in human trials.
背景
开发一种用于皮肤利什曼病（CL）的局部治疗方法是改善病损管理的重要一步。两性霉素B（AmB）对多种利什曼原虫有效，但具有毒性。已开发出一种大小约为100纳米的纳米脂质体形式的AmB（脂质体两性霉素B，Lip-AmB），并在动物模型中显示对多种利什曼原虫有效。本研究旨在通过家兔皮肤刺激试验（Draize试验）进行检验，并于2012年在德黑兰医科大学皮肤病与麻风病研究与培训中心完成。
方法
20只家兔分3个步骤单独饲养，采用人工照明（12小时光照/12小时黑暗）。将SinaAmpholeish乳膏或空脂质体（在伊朗德黑兰米诺公司按照药品生产质量管理规范条件制备）涂抹在纱布贴片上，然后将贴片放置在家兔背部皮肤的指定部位。在48小时和72小时后，检查、评分并记录红斑和水肿情况。
结果
家兔使用SinaAmpholeish后的红斑评分为0.83±0.41，使用空脂质体后的红斑评分为0.5±0.55（P = 0.16）。SinaAmpholeish的水肿平均评分为0.67±0.52，空脂质体的水肿平均评分为0.33±0.52（P = 0.16）。
结论
基于皮肤刺激反应，SinaAmpholeish的局部制剂是安全的，可在人体试验中进一步检验。
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