Echinacea: Standardized Product & Supply Provision

SBIR一期将为二期的紫锥菊标准化生产奠定基础。后续分析化学测试的原料来源将首先解决：紫锥菊种子将进行纯度测试和鉴定，然后在不同的季节/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和微观特征。同时，将在前6个月内开发出以后使用的所有标记化合物和检测方法。标记化合物测试将在最近6个月内开始，使用盖亚草药有机农场的样本。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，植物的部分，物种和园艺。将根据标记化合物分析开发不同的提取制剂，并根据提取质量开发产品。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料来源，收集植物特性的数据；2)标记化合物的制备及检测方法；3)标记化合物测试，通过不同的提取溶剂和策略（即，与植物部位和物种的化学成分浓度相关的最佳组合提取类型）确定有希望的最终产品；4)评估最佳交付呈现和产品稳定性；5)第二阶段的执行和指导，以实现第一阶段的里程碑；6)与草药行业和监管机构分享获得的知识和实践。一期种植的生长中的紫锥菊将为二期提供为期三年的分析测试和产品开发样本，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年的植物必须经过仔细监测和鉴定，才能启动二期。长期目标包括为草药工业和草药农场开发可行的新技术。最终希望为消费者、研究者、草药行业和医疗保健提供者提供易于识别的产品质量和标识，并科学地确立或否定紫锥菊的药用价值。拟议的商业应用：在生产可复制的紫锥菊产品的过程中，新的创新技术也将贯穿整个生产过程。所有这些都可以进行修改和进一步开发以用于商业应用：1)简单，快速，经济的物种/种子鉴定测试；2)具有商业可行性的标记成分分析测试方法；3)温室高产发芽的条件和材料；4)土壤状况和选用的优质原料；5)有机农业中不耗时也不昂贵的农药/除草剂替代品；（六）与研究产品质量相同的紫锥菊产品；7)便于消费者使用的产品交付形式（形式、包装），产品质量、浓度、纯度稳定至保质期。

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.