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原料来源：紫锥菊种子将经过测试和纯度鉴定，然后在不同季节/土壤/田间条件下萌发和栽培，并将对形态、感官、染色体/DNA和显微特征进行系统监测和记录。同时，所有稍后使用的标记化合物和测试方法将在前6个月开发完成。标记化合物测试将在最近6个月内开始，使用的是盖亚草药有机农场的样品。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本，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提取制剂，并根据提取质量开发产品。然后，将在重新测试分析的基础上开发最理想的交付形式。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，收集有关植物特性的数据；2)准备标记化合物和测试方法；3)标记化合物测试，以确定使用不同提取溶剂和策略的有希望的最终产品(即，与植物部分和物种的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，以实现第一阶段里程碑；6)与草药行业和监管机构分享获得的知识和做法。在第一阶段种植的紫锥菊将在第二阶段提供为期三年的分析测试和产品开发样本，更关键的是，必须提供在不同土壤条件和收获时间生长的1、2和3年生植物的仔细监测和特征，以启动第二阶段。长期目标包括对草药行业和草药农场可行的新技术开发。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，并科学地确定或反驳紫锥菊的药用价值。建议的商业应用：在制造可重复生产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。以下所有内容都可以修改和进一步开发用于商业应用：1)简单、快速和经济的物种/种子鉴定；2)商业上可行的标记成分分析测试方法；3)温室中用于高产萌发的条件和材料；4)土壤条件和用作优质原料的材料；5)用于有机耕作的杀虫剂/除草剂的替代品，既不耗时也不昂贵；6)与研究产品质量相同的紫锥菊产品；7)方便消费者的产品交付展示(形式和包装)，质量、浓度、纯度均稳定至有效期。

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.