| 中文摘要 |
中藥之規格化、標準化，是中藥邁向現代化、國際化必經之路。加味逍遙散為常用和解劑，是衛生署公告訂定統一規範的基準方，但檢驗市售不同GMP 廠產品，發現品質有所不同。中藥的品質主要決定於原料藥材基原的正確性、產品的安全性、一致性與有效性。本研究依據中藥典籍記載及各國藥典規範，建議採用道地的Angelica sinensis ， Atractylodesmacrocephala，Paeonia lactiflora，Bupleurum chinense，Poria cocos，Glycyrrhiza uralensis，Paeoniasuffruticosa，Gardenia jasminoides，Zingiber officinale 及 Mentha haplocalyx 等十味藥材，明確訂定各自（廠規）的性狀、理化性質、重金屬含量、致病菌及定性定量分析等規格，作為每一批產品檢驗報告書的作業標準；為確定批次間的一致性，本文提出建議以三維層析圖譜及雷達圖（geniposide，paeoniflorin，glycyrrhizin 及三特殊波峰）作為長期品管之監控。Standardization is the way that leads to modernization and globalization of Chinese herbal medicine. Chia-wei-hsiao-yao-san (Bupleurum and Peony Formula) is a popular harmonizing formula and one of the standardized formulas announced by Health Department in Taiwan. However, the quality of the same product found on the market produced by different GMP manufacturers varies significantly. Top quality Chinese herbal medicine is determined by the authenticity of herb material, product safety, consistency and efficacy. This study is based on Chinese Pharmacopoeia recording of the following standard raw herbs: Angelica sinensis, Atractylodes macroccphala, Paconia lactiflora, Buplcurum Chinese, Poria cocos, Glycyrrhiza uralensis, Paeonia suffruticosa, Gardenia jasminoides, Zingiber officinale and Mentha haplocalyx. Specifications for each herb’s physicochemical properties, heavy metal content, microbiological contamination and HPLC for qualitative and quantitative analysis should be set according to each country’s Pharmacopoeia. As a quality control monitoring, this study recommends using the three-dimension chromatogram and radar graph (geniposide, paconiflorin, glycyrrhizin and three other substances) to ensure the product’s batch-tobatch consistency. |
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