Validation of a Toll-like Receptor (TLR)2/TLR1 Activation Assay for Biological Standardization of Arthrospira/Limnospira Immune-Enhancing Potency.
Validation of a Toll-like Receptor (TLR)2/TLR1 Activation Assay for Biological Standardization of Arthrospira/Limnospira Immune-Enhancing Potency.
复制标题
Toll 样受体 (TLR)2/TLR1 激活测定的验证，用于节旋藻/Limnospira 免疫增强效力的生物标准化。
DOI：
10.1080/19390211.2023.2263566
复制
发表时间：
2024
影响因子：
2.5
通讯作者：
Pugh,NirmalD
中科院分区：
文献类型：
--
作者：
Haron,MonaH;Zhang,Jin;Chittiboyina,AmarG;Khan,IkhlasA;Pugh,NirmalD
节旋藻/湖螺旋藻是世界上流行的植物膳食补充剂，数百年来一直作为食品消费。我们的研究小组正在进行的努力集中在评估aLimnospira衍生的口服补充剂（Immulina）在促进对流感病毒感染的恢复力方面的效用。与其他植物提取物一样，Immulina本质上是一种复杂的基质，其化学成分水平存在差异。因此，为了确保未来科学研究和临床研究的治疗一致性，我们正在开发使用生物测定和化学标记物的标准化技术。Braun型脂蛋白是一类激活Toll样受体（TLR）2/TLR 1信号通路的大分子，已被鉴定为Immulina中的主要活性成分。基于Braun型脂蛋白的作用机制，建立了免疫增强剂免疫增强作用的HEK-Blue hTLR 2/TLR 1细胞体外生物测定法。本研究的目的是使用美国FDA植物药开发指南文件和美国药典建议验证Immulina活性定量的生物测定。确定了系统适用性、参比标准品和定义效价单位。性能参数验证包括精密度、专属性、准确度、线性和范围。验证Immulina活性的这种生物测定提供了一种工具，用于确保产品的一致性和量化这种植物的效力，以用于未来的研究以及消费市场的材料。
Arthrospira/Limnospirais a popular botanical dietary supplement throughout the world and has been consumed as a food product for hundreds of years. Ongoing efforts from our research group are focused on evaluating the utility of aLimnospira-derived oral supplement (Immulina) in promoting resilience against influenza viral infection. Like other botanical extracts, Immulina is inherently a complex matrix with variation in the levels of its chemical constituents. Therefore, to ensure therapeutic consistency for future scientific research and clinical studies, we are developing standardization technology using a bioassay and chemical markers. Braun-type lipoproteins, a class of macromolecules that activate the Toll-like receptor (TLR)2/TLR1 signaling pathway, have been identified as a major active component within Immulina. Based on the mechanism of action of the Braun-type lipoproteins, anin vitrobioassay was established using the HEK-Blue hTLR2/TLR1 cell line to quantitate the immune-enhancing potency of Immulina. The objective of the current research was to validate that bioassay for Immulina activity quantification using the U.S. FDA guidance document for botanical drug development and U.S. Pharmacopeia recommendations. System suitability, reference standards and defining potency units were established. Validation of performance parameters included precision, specificity, accuracy, linearity, and range. Validating this bioassay for Immulina activity provides a tool for ensuring product consistency and quantifying the potency of this botanical for use in future research as well as material in the consumer market.