Author:
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
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. Based on comprehensive chemical and biological fingerprints correlated with pharmacology, we propose a general approach called PhytomicsQC to botanical quality control.
Methods
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 in vivo 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.
Results
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.
Conclusion
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.
Publisher
Springer Science and Business Media LLC
Subject
Complementary and alternative medicine,Pharmacology
Reference30 articles.
1. van Breemaen RB, Fong HHS, Farnsworth NR: The role of quality assurance and standardization in the safety of botanical dietary supplements. Chem Res Toxicol. 2007, 20 (4): 577-82. 10.1021/tx7000493.
2. Khan IA: Issues related to botanicals. Life Sci. 2006, 78 (18): 2033-2038. 10.1016/j.lfs.2005.12.019.
3. Zhou Y, Hang Y, Chen B: Study on the original plants and macroscopic characters of Radix Paeoniae. Zhongyaocai. 2005, 28 (10): 877-879.
4. Kondo K, Shiba M, Yamaji H, Morota T, Zhengmin C, Huixia P, Shoyama Y: Species identification of licorice using nrDNA and cpDNA genetic markers. Biol Pharm Bull. 2007, 30 (8): 1497-1502. 10.1248/bpb.30.1497.
5. Yip PY, Chau CF, Mak CY, Kwan HS: DNA methods of identification of Chinese medicinal materials. Chin Med. 2007, 2: 9-10.1186/1749-8546-2-9.
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