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

Siu-Po Ip,Ming Zhao,Joseph Jy Sung,Chun-Tao Che,Brian Berman,Mengli Chen,Sam-Hip Tsai,Yanfang Xian,Harry Hs Fong,Yuying Zong,Yung-Wui Tjong,Alan Bensoussan

doi:10.1186/1749-8546-5-8

Abstract

BackgroundThe 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.MethodsPurity 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.ResultsQuality 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.ConclusionA 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.

Highlights

The employment of well characterized test samples prepared from authenticated, high quality medicinal plant materials is key to reproducible herbal research
As part of a research project to evaluate the therapeutic potential of a 20-herb Chinese medicine formula for treating irritable bowel syndrome
Cortex Phellodendri refers to the bark of either Phellodendron amurense or Phellodendron chinense which are similar in macroscopic appearance and used interchangeably in Chinese medicine

Summary

Introduction

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. Lack of effective quality assurance affects the efficacy and safety assessment of herbal products [1,2,3,4,5,6,7]. For valid pharmacological or clinical efficacy evaluations, a standardized single batch clinical formulation should be employed. As part of a research project to evaluate the therapeutic potential of a 20-herb Chinese medicine formula (the IBS-20 formula) for treating irritable bowel syndrome (IBS), we have developed and tested a quality assurance program for the production of the multi-herb preparation. IBS affects 10-20% of the global population [8] and it has not been successfully treated with conventional medications such as bulking, smooth muscle relaxant, prokinetic and psychotropic agents, nor loperamide and peppermint oil [9]

Methods

Results

Conclusion