METHOD FOR MAKING AN IMPROVED ST JOHN'S WORT PRODUCT

描述(改编自应用程序)：本阶段I/II的目标 快车道项目是开发一种改进的圣约翰麦芽汁产品，它可以 以标准化和可重复的方式制造。圣约翰麦芽汁 含有多种生物活性化合物，已被广泛用于 疾病，最明显的是内源性抑郁症。该方法涉及到使用 含和不含极性共溶剂的超临界流体和近临界流体 例如醇(商标为超流体)。这些流体是如下气体 二氧化碳在压缩时表现出增强的热力学性质 可以对其进行微调，以便快速和选择性地提取生物活性 分子。 在第一阶段，选择性超流萃取的最佳条件和 将建立圣约翰麦芽汁的层析纯化方法。在……里面 初步研究，这是通过提取 含超临界二氧化碳的生物活性化合物 20%的甲醇。第一阶段的研究结果将用于开发一个大型的 规模化制造工艺。在第二阶段调查中，以下条件 生物活性物质的选择性提取和层析纯化 将在机械部件、增强功能方面进一步优化 设备和运行参数。最后，提出了设计、建造和施工的建议。 测试一个可以在cGMP条件下运行的中试规模的原型工厂。 Paracelsian(伊萨卡，纽约州)将按合同进行5-羟色胺摄取分析。 建议的商业应用： 百忧解是美国应用最广泛的抗抑郁药 礼来公司的Zoloft，辉瑞公司的Zoloft和SmithKline Beecham的Paxil。世界范围内 最畅销的抗抑郁药的销售额约为48亿美元。作为人类 经历过处方抗抑郁药物的不良反应，有 随之而来的是圣约翰草和其他草药作为天然抗精神病药物的使用增加 镇静剂。这一一期/二期快速通道SBIR项目应该会导致 一种生物增强、稳定和标准化的圣约翰麦芽汁产品，可以 在cGMP条件下制造，提供侧边减少的天然替代品 百忧解、辉瑞和帕罗西汀的效果，从而满足 价值48亿美元的抗抑郁药市场。

DESCRIPTION (Adapted from the application): The goal of this Phase I/Phase II Fast Track project is to develop an improved St. John's Wort product which can be manufactured in a standardized and reproducible manner. St. John's Wort contains multiple bioactive compounds that have been used in a wide variety of ailments, most notably endogenous depression. The approach involves the use of supercritical fluids and near-critical fluids with and without polar cosolvents such as alcohols (trademarked as SuperFluids). These fluids are gases such as carbon dioxide which when compressed exhibit enhanced thermodynamic properties that can be fine-tuned for rapid and selective extraction of bioactive molecules. In Phase I, optimal conditions for selective SuperFluids extraction of and chromatographic purification of St. John's Wort will be established. In preliminary studies, this was accomplished by following the extraction of bioactive compounds with super critical carbon dioxide with 0 to 20% methanol. The results of Phase I studies will be used to develop a large scale manufacturing process. In a Phase II investigation, the conditions for selective extraction and chromatographic purification of bioactive compounds will be further optimized in terms of mechanical components, enhancement devices and operating parameters. Finally, it is proposed to design, build and test a pilot-scale prototype plant that could operate under cGMP conditions. Paracelsian (Ithaca, NY) will perform serotonin uptake assays on contract. PROPOSED COMMERCIAL APPLICATION: Among the most widely prescribed antidepressants in the United States are Prozac from Eli Lilly, Zoloft from Pfizer and Paxil from SmithKline Beecham. The worldwide sales of the top selling antidepressants are approximately $4.8 billion. As people experience adverse side-effects from prescription antidepressants, there has been a concomitant rise in the use of St. John's Wort and other herbs as natural anti- depressants. This Phase I/Phase II Fast Track SBIR project should lead to the development of a biologically-enhanced, stable and standardized St. John's Wort product that can be manufactured under cGMP conditions to provide a natural alternative with reduced side effects of Prozac, Pfizer and Paxil, and thus satisfy a burgeoning market demand in the $4.8 billion antidepressant marketplace.