Echinacea: Standardized Product & Supply Provision

SBIR第一阶段将为第二阶段的标准化紫锥菊生产奠定基础。将首先解决后续分析化学测试的粗材料来源：将测试和鉴定紫锥菊种子的纯度，然后在不同季节/土壤/田间条件下发芽和培养，并系统地监测和记录形态，感官，染色体/DNA和显微特征。同时，将在前6个月开发随后使用的所有标记化合物和检测方法。标记化合物检测将在过去6个月内开始，使用来自Gaia Herbs有机农场的样品。测试将包括代表影响紫锥菊潜在药用活性的不同因素的样品，例如，植物、物种和园艺的部分。将根据标记化合物分析开发不同的浸提制剂，并根据浸提质量开发产品。然后将根据重新测试分析制定最理想的交付形式。因此，第一阶段的具体目标包括：1）准备用于第二阶段的原材料来源，收集关于植物身份的数据; 2）准备标记化合物和测试方法; 3）标记化合物测试，以使用不同的提取溶剂和策略（即，与植物部分和物种中化学成分浓度相关的最佳组合提取类型）; 4）评估最佳交付方式和产品稳定性; 5）执行和指导第二阶段以交付第一阶段里程碑; 6）与草药行业和监管机构分享所获得的知识和实践。第一阶段种植的紫锥菊将为第二阶段的分析测试和产品开发提供三年的样品，更重要的是，在不同土壤条件和收获时间下生长的1、2和3年生植物必须经过仔细监测和表征，才能开始第二阶段。长期目标包括为草药行业和草药农场开发新技术。最终的希望是为消费者、研究人员、草药行业和医疗保健提供者提供易于识别的产品质量和身份，并科学地建立或反驳紫锥菊的药用价值。拟议的商业应用：在生产可再生的紫锥菊产品的过程中，新的创新技术也将在整个生产过程中得到发展。所有以下内容都可以修改并进一步开发用于商业应用：1）简单、快速和经济的物种/种子的身份测试; 2）商业上可行的标记成分分析测试方法; 3）用于温室中高产发芽的条件和材料; 4）用于优质原料的土壤条件和材料; 5）用于有机农业的杀虫剂/除草剂的替代品，既不耗时也不昂贵; 6）以与研究产品相同的质量生产的紫锥菊产品; 7）产品交付展示（形式和包装），方便消费者，其质量、浓度和纯度稳定至有效期。

SBIR phase I will lay the groundwork for standardized Echinacea production in Phase II. The source of crude material for subsequent analytical chemistry testing will be first addressed: Echinacea seeds will be tested and identified for purity, then germinated and cultivated at different seasons/soil/field conditions, and morphologic, organoleptic, chromosome/DNA, and microscopic characteristics will be systematically monitored and recorded. Simultaneously, all marker compounds and testing methodology to be used later will be developed in the first 6 months. The marker compound testing will begin in the last 6 months using samples from Gaia Herbs organic farm. The testing will include samples representing the different factors that influence the potential medicinal activities of Echinacea, e.g., parts of plant, species, and horticulture. Different extraction preparations will be developed based on marker compound analysis, and products developed based on extraction quality. The most desirable delivery forms will then be developed based on retesting analysis. Thus, specific aims of Phase I include: 1) preparation of raw material source for use in Phase II, data collection on plant identity; 2) preparation of marker compounds and testing methods; 3) marker compound testing to identify promising end products using different extraction solvents and strategy (i.e., best combination extraction types correlated with chemical component concentrations in plant parts and species); 4) evaluate optimum delivery presentation and product stability; 5) execution and direction of Phase II to deliver Phase I milestone; 6) share the knowledge and practices gained with the herbal industry and regulatory agencies. The growing Echinacea planted in Phase I will provide samples for analytical testing and product development for three years in Phase II, and more critically, the carefully monitored and characterized 1,2, and 3 year old plants growing in different soil conditions and harvesting times must be available to start Phase II. Long-term goals include new technology development viable for herbal industry and herb farms. The ultimate hope is to provide consumers, researchers, herbal industry, and health- care providers with easily recognized product quality and identity, and to scientifically establish or disprove the medicinal value of Echinacea. PROPOSED COMMERCIAL APPLICATIONS: In the process of manufacturing reproducible Echinacea products, new innovative technologies will also be developed through out the production process. All of the following can be modified and further developed for commercial application: 1) Identity testing of species/seeds that is simple, fast, and economical; 2) marker component analytical testing methodology that is commercially viable; 3) condition and materials used in the greenhouse for high-yield germination; 4) soil condition and materials used for quality raw material; 5) alternatives to pesticides/herbicides for organic farming that is not time consuming nor expensive; 6) Echinacea product that is manufactured in the same quality as the research products; and 7) product delivery presentation (form and package) that is convenient for consumers, which is also stable in quality, concentration, and purity to the date of expiration.