http://www.ncbi.nlm.nih.gov/pubmed/20727161

Tilton R, Paiva AA, Guan J, Marathe R, Jiang Z, van Eyndhoven W, Bjoraker J, Prusoff Z, Wang H, Liu SH, Cheng YC.
Abstract

ABSTRACT: Background Establishing botanical extracts as globally-accepted polychemical medicines and a new paradigm for disease treatment, requires the development of high-level quality control metrics. Without a full understanding of the active compounds or their effects on multiple biochemical pathways, comprehensive chemical and biological fingerprints correlated with animal pharmacology provide a general approach for botanical quality control that is termed PhytomicsQC. Methods Incorporating different analytical methodologies, PhytomicsQC is a flexible platform that currently utilizes liquid chromatography/mass spectrometry (LC/MS) for chemical characterization and chemical fingerprints, differential cellular gene expression as a novel bioresponse fingerprints and animal pharmacology for in vivo validation. A statistical pattern comparison method, Phytomics Similarity Index (PSI), based on intensities and intensity ratios, is used to score the similarity of different manufactured batches based on the chemical and bioresponse fingerprints. Results Eighteen different samples of a traditional Chinese medicine formulation, Huangqin Tang (HQT) or a pharmaceutical grade version, PHY906, are analyzed using the PhytomicsQC platform. The chemical fingerprint captures over 85% of the total ion current associated with the LC/MS analysis. The bioresponse fingerprint utilizes a diverse set of gene responses to monitor biologically relevant phytochemical changes in the botanical formulation. Quantitative differences in both the chemical and bioresponse patterns, can be used to sensitively compare the similarity of two or more batches. The PSI scoring function is found to have improved sensitivity compared with more traditional correlation methods and provides a quantitative value ranging between 0.0 (no similarity) and 1.0 (complete identity). Comparative analysis of various manufactured batches with a clinically tested standardized batch, indicate values of similarity ranging from 0.67 to 0.99. Conclusion While botanical formulations can differ dramatically from vendor to vendor, it can be demonstrated with analytically sensitive and comprehensive chemical and biological fingerprints that botanical formulations manufactured under strict manufacturing protocols can produce highly similar extract products, even with herbal ingredients harvested from different years.