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Open Access Research

Quality assurance for Chinese herbal formulae: standardization of IBS-20, a 20-herb preparation

Siu-Po Ip1, Ming Zhao1, Yanfang Xian1, Mengli Chen1, Yuying Zong1, Yung-Wui Tjong1, Sam-Hip Tsai1, Joseph JY Sung2, Alan Bensoussan3, Brian Berman4, Harry HS Fong5 and Chun-Tao Che1*

Author Affiliations

1 School of Chinese Medicine, Chinese University of Hong Kong, Hong Kong SAR, China

2 Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong SAR, China

3 Centre for Complementary Medicine Research, University of Western Sydney, Australia

4 Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA

5 Department of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, University of Illinois at Chicago, Chicago, USA

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Chinese Medicine 2010, 5:8  doi:10.1186/1749-8546-5-8

Published: 22 February 2010

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 the composite formula were established. An aqueous extract of the mixture of the 20 herbs was prepared and formulated into IBS-20, which was chemically standardized by LC-MS, with 20 chemical compounds serving as reference markers. The stability of the formula was monitored and shown to be stable at room temperature.

Conclusion

A quality assurance program has been developed for the preparation of a standardized 20-herb formulation for use in the clinical studies for the treatment of irritable bowel syndrome (IBS). The procedures developed in the present study will serve as a protocol for other poly-herbal Chinese medicine studies.