原创力文档quality assurance for chinese herbal formulae standardization of ibs-20, a 20-herb preparation质量保证中药标准化公式ibs-20,20-herb准备.pdfVIP
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quality assurance for chinese herbal formulae standardization of ibs-20, a 20-herb preparation质量保证中药标准化公式ibs-20,20-herb准备
Ip et al. Chinese Medicine 2010, 5:8
/content/5/1/8
RESEARCH Open Access
Quality assurance for Chinese herbal formulae:
standardization of IBS-20, a 20-herb preparation
1 1 1 1 1 1 1
Siu-Po Ip , Ming Zhao , Yanfang Xian , Mengli Chen , Yuying Zong , Yung-Wui Tjong , Sam-Hip Tsai ,
2 3 4 5 1*
Joseph JY Sung , Alan Bensoussan , Brian Berman , Harry HS Fong , Chun-Tao Che
Abstract
Background: The employment of well characterized test samples prepared from authenticated, high quality
medicinal plant materials is key to reproducible herbal research. The present study aims to demonstrate a quality
assurance program covering the acquisition, botanical validation, chemical standardization and good
manufacturing practices (GMP) production of IBS-20, a 20-herb Chinese herbal formula under study as a potential
agent for the treatment of irritable bowel syndrome.
Methods: Purity and contaminant tests for the presence of toxic metals, pesticide residues, mycotoxins and
microorganisms were performed. Qualitative chemical fingerprint analysis and quantitation of marker compounds
of the herbs, as well as that of the IBS-20 formula was carried out with high-performance liquid chromatography
(HPLC). Extraction and manufacture of the 20-herb formula were carried out under GMP. Chemical standardization
was performed with liquid chromatography-mass spectrometry (LC-MS) analysis. Stability of the formula was
monitored with HPLC in real time.
Results: Quality component herbs, purchased from a GMP supplier were botanically and chemically authenticated
and quantitative HPLC profiles (fingerprints) of each component herb and of t
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