Pre-clinical Studies on Lupinus termis Seeds Extract

描述(申请人提供)：特应性皮炎是一种皮肤疾病， 据估计，影响到10%-20%的人口。除了主题 (他克莫司)软膏，这是最近被FDA批准的，主要 在过去的40年里，治疗一直是类固醇。这项建议的目的是 对一种乙醇提取物进行初步的药理-毒理学研究 从一种植物的种子中获得，在早期的临床研究中进行了 在美国以外，在慢性病的管理方面表现出令人鼓舞的活动 手足湿疹。 将获得的结果将用于制定未来的R01赠款 将包括II期临床试验以评估该提取物的应用 治疗慢性特应性皮炎。 这些研究的目的是1)通过以下方式确保进口种子的质量 分析从来源国获得的不同作物，在一段时间内 两年；2)开发一种标准化的可重复使用的方法来制备 提取液；3)测定由黄连提取液制备的软膏的稳定性 摘录； 4)对软膏进行重复剂量毒理学研究，为期9个月， 在猪中；5)对大鼠进行系统性暴露于 提取物，口服90天；6)进行一系列 遗传毒理学研究，以及7)调查提取物和软膏是否 制剂有可能诱导致敏。 原始材料是一种商业经济作物。批准的实验程序 由美国药典/国家药典或著名出版商出版 将在质量保证研究中使用协议。动物们将会是 安徽医科大学校区动物资源中心 波多黎各大学，在整个研究期间，在照顾下 该设施的兽医。这个设施是由美国认证的 实验动物护理认可协会(AAALAC 国际) 开发一种治疗慢性特应性皮炎的新草药疗法将受益 有风险或对其他疗法产生抵抗力的患者， 包括普罗托普。

DESCRIPTION (provided by applicant): Atopic dermatitis is a skin condition that affects an estimated 10-20 percent of the population. Aside from Protopic (tacrolimus) ointment, which has been recently approved by the FDA, the main treatment for the past 40 years has been steroids. This proposal is intended to carry out preliminary pharmacology-toxicology studies on an alcoholic extract obtained form the seeds of a plant which, in earlier clinical studies performed outside the US, demonstrated encouraging activity in the management of chronic hand and foot eczema. The results that will be obtained will be used to develop a future R01 grant application that will include a phase II clinical trial to evaluate the extract in the treatment of chronic atopic dermatitis. The studies are intended to 1) assure the quality of the imported seeds, by analyzing different crops obtained from the source country, over a period of two years; 2) develop a standardized reproducible method for the preparation of the extract; 3) determine the stability of the ointments prepared from the extract; 4) carry out a repeat-dose toxicology study of the ointments, for nine months, in pigs; 5) carry out a systemic exposure of rats to the active components of the extract, for 90 days, by oral administration; 6) perform a battery of genetic toxicology studies, and 7) investigate whether the extract and ointment preparations have the potential to induce sensitization. The source material is a commercial cash crop. Experimental procedures approved by the U.S. Pharmacopeia/National Formulary, or well-established published protocols will be used in the quality assurance studies. The animals will be housed in the Animal Resources Center of the Medical Sciences Campus of the University of Puerto Rico, throughout the period of the study, under the care of the facility's veterinarian. This facility is accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC International) Developing a new herbal treatment for chronic atopic dermatitis will benefit patients who are at risk or who have developed resistance to other therapies, including Protopic.