Pre-clinical Studies on Lupinus termis Seeds Extract

描述（由申请人提供）：特应性皮炎是一种皮肤病， 影响了大约10- 20%的人口。除了Protopic （他克莫司）软膏，最近已被FDA批准，主要 过去40年的治疗方法都是类固醇。这项建议旨在 对一种酒精提取物进行初步的药理毒理学研究 从植物的种子中获得，在早期的临床研究中， 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开发未来的R 01赠款 申请将包括第二阶段临床试验，以评估提取物 治疗慢性特应性皮炎 这些研究的目的是：1）确保进口种子的质量， 分析在一段时期内从来源国获得的不同作物， 2）制定一个标准化的可重复的方法，用于制备 提取物; 3）测定由所述提取物制备的软膏的稳定性。 提取物; 4)对药膏进行为期九个月的重复剂量毒理学研究， 在猪中; 5）使大鼠全身暴露于 该提取物，90天，通过口服给药; 6）进行一系列 遗传毒理学研究，和7）调查是否提取物和软膏 制剂具有诱发致敏的潜力。 原材料是一种经济作物。批准的实验程序 美国药典/国家处方集，或公认的出版物 在质量保证研究中将使用规程。将动物 动物资源中心（Animal Resources Center of the Medical Sciences Campus） 波多黎各大学，在整个学习期间，在照顾 兽医的名字这个设施是由美国政府 实验动物管理认证协会（AAALAC 国际） 开发一种新的草药治疗慢性特应性皮炎将受益 有风险或对其他疗法产生耐药性的患者， 包括Protopic。

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.