一个全面的植物药质量控制平台（PhytomicsQC）：以黄芩汤（HQT）和 PHY906 为例。
A comprehensive platform for quality control of botanical drugs (PhytomicsQC): a case study of Huangqin Tang (HQT) and PHY906.
机构信息
Department of Pharmacology, Yale University School Of Medicine, New Haven, CT 06510, USA.
出版信息
Chin Med. 2010 Aug 20;5:30. doi: 10.1186/1749-8546-5-30.
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.
背景
将植物提取物确立为全球认可的多化学成分药物，并开创疾病治疗的新模式，需要制定高水平的质量控制指标。基于与药理学相关的全面化学和生物指纹图谱，我们提出了一种名为 PhytomicsQC 的植物质量控制通用方法。
方法
本研究采用了最先进的分析方法，整合了 PhytomicsQC，包括使用液相色谱/质谱（LC/MS）进行化学特征和化学指纹分析、差异细胞基因表达进行生物反应指纹分析以及动物药理学进行体内验证。基于强度和强度比的 Phytomics 相似性指数（PSI）是一种统计模式比较方法，用于确定不同制造批次之间的化学和生物反应指纹图谱的相似性。
结果
使用 PhytomicsQC 平台分析了 18 批黄芩汤（HQT）及其医药级版本（PHY906）的样品。对具有临床测试的标准化批次的批次样品进行比较分析，PSI 相似性值在 0.67 到 0.99 之间。
结论
通过使用分析敏感且全面的化学和生物指纹图谱进行严格的质量控制，在标准化制造协议下制造的植物配方可以生产出高度一致的批次产品。
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