Mona H Haron, Jin Zhang, Amar G Chittiboyina, Ikhlas A Khan, Nirmal D Pugh
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引用次数: 0
Abstract
Arthrospira/Limnospira is 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 a Limnospira-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, an in vitro bioassay 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.
期刊介绍:
The Journal of Dietary Supplements (formerly the Journal of Nutraceuticals, Functional & Medical Foods) has been retitled to reflect the bold departure from a traditional scientific journal presentation to a leading voice for anyone with a stake in dietary supplements. The journal addresses important issues that meet the broad range of interests from researchers, regulators, marketers, educators, and health professionals from academic, governmental, industry, healthcare, public health, and consumer education sectors. This vital tool not only presents scientific information but interprets it - helping you more readily pass it on to your students, patients, clients, or company.