School of Chinese Medicine, Chinese University of Hong Kong, Hong Kong SAR, China.
Chin Med. 2010 Feb 22;5:8. doi: 10.1186/1749-8546-5-8.
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.
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.
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.
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.
使用经过充分特征描述的测试样本，这些样本由经过认证的、高质量的药用植物材料制成，是重现草药研究的关键。本研究旨在展示一个涵盖 IBS-20 质量保证计划，该计划涵盖了获取、植物学验证、化学标准化和良好生产规范 (GMP) 生产。IBS-20 是一种 20 种草药的中药配方，正在研究作为治疗肠易激综合征的潜在药物。
进行了纯度和污染物测试，以检测是否存在有毒金属、农药残留、霉菌毒素和微生物。采用高效液相色谱法 (HPLC) 进行定性化学指纹分析和草药标志物以及 IBS-20 配方的定量分析。在 GMP 下进行 20 种草药配方的提取和制造。采用液相色谱-质谱联用 (LC-MS) 分析进行化学标准化。采用 HPLC 实时监测配方的稳定性。
从 GMP 供应商处购买的质量成分草药经过植物学和化学鉴定，并建立了每种成分草药和复合配方的定量 HPLC 图谱（指纹）。制备了 20 种草药混合物的水提取物，并将其配制成 IBS-20，通过 LC-MS 进行化学标准化，以 20 种化学化合物作为参考标记。监测配方的稳定性并表明在室温下稳定。
为治疗肠易激综合征 (IBS) 的临床研究制备标准化的 20 种草药配方制定了质量保证计划。本研究中开发的程序将作为其他多草药中药研究的方案。
