A comprehensive platform for quality control of botanical drugs (PhytomicsQC): a case study of <it>Huangqin Tang </it>(HQT) and PHY906

• Main Authors: Tilton Robert, Paiva Anthony A, Guan Jing-Qu, Marathe Rajendra, Jiang Zaoli, van Eyndhoven Winfried, Bjoraker Jeffrey, Prusoff Zachary, Wang Hailong, Liu Shwu-Huey, Cheng Yung-Chi
• Format: Article
• Language: English
• Published: BMC 2010-08-01
• Series: Chinese Medicine
• Online Access: http://www.cmjournal.org/content/5/1/30

<p>Abstract</p> <p>Background</p> <p>Establishing botanical extracts as globally-accepted polychemical medicines and a new paradigm for disease treatment, requires the development of high-level quality control metrics. Based on comprehensive chemical and biological fingerprints correlated with pharmacology, we propose a general approach called PhytomicsQC to botanical quality control.</p> <p>Methods</p> <p>Incorporating the state-of-the-art analytical methodologies, PhytomicsQC was employed in this study and included the use of liquid chromatography/mass spectrometry (LC/MS) for chemical characterization and chemical fingerprinting, differential cellular gene expression for bioresponse fingerprinting and animal pharmacology for <it>in vivo </it>validation. A statistical pattern comparison method, Phytomics Similarity Index (PSI), based on intensities and intensity ratios, was used to determine the similarity of the chemical and bioresponse fingerprints among different manufactured batches.</p> <p>Results</p> <p>Eighteen batch samples of Huangqin Tang (HQT) and its pharmaceutical grade version (PHY906) were analyzed using the PhytomicsQC platform analysis. Comparative analysis of the batch samples with a clinically tested standardized batch obtained values of PSI similarity between 0.67 and 0.99.</p> <p>Conclusion</p> <p>With rigorous quality control using analytically sensitive and comprehensive chemical and biological fingerprinting, botanical formulations manufactured under standardized manufacturing protocols can produce highly consistent batches of products.</p>