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 快速通道项目是开发一种改进的圣约翰麦汁产品， 以标准化和可重复的方式生产。圣约翰草 含有多种生物活性化合物，这些化合物已用于各种 疾病，尤其是内源性抑郁症。该方法涉及使用 具有和不具有极性共溶剂的超临界流体和近临界流体 例如醇（商标为SuperFluids）。这些流体是气体，例如 当压缩时表现出增强的热力学性质的二氧化碳 其可以被微调以用于快速和选择性地提取生物活性物质， 分子。 在第一阶段，选择性超流体萃取的最佳条件， 将建立圣约翰草的色谱纯化。在 初步研究，这是通过以下提取 生物活性化合物与超临界二氧化碳的反应， 20%甲醇。第一阶段研究的结果将用于开发一个大型的 规模生产过程。在第二阶段调查中， 生物活性化合物的选择性提取和色谱纯化 将进一步优化机械部件，增强 设备和操作参数。最后，建议设计、建造和 测试可在cGMP条件下运行的中试规模原型工厂。 Paracelsian（Ithaca，NY）将根据合同进行5-羟色胺摄取试验。 拟定商业应用： 美国最广泛使用的抗抑郁药之一是百忧解 辉瑞的左洛复和史克必成的帕罗西汀。全球 最畅销的抗抑郁药的销售额约为48亿美元。随着人们 经历处方抗抑郁药的不良副作用， 伴随着使用圣约翰草和其他草药作为天然抗- 镇静剂该第一阶段/第二阶段快速通道SBIR项目应导致开发 一种生物增强的、稳定的和标准化的圣约翰麦芽汁产品， 在cGMP条件下生产，以提供天然替代品， 百忧解，辉瑞和帕罗西汀的效果，从而满足新兴的市场需求， 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.