三黃瀉心湯濃縮方劑與水煎劑中活性指標成分相對生可用率之研究
侯鈺琪
中國醫藥大學
目前臺灣中醫臨床上使用之中藥劑型主要為傳統水煎劑及濃縮製劑。其中濃縮製劑為全民健保給付的劑型，因此中藥濃縮製劑之應用佔健保費支出比率相當可觀。然而自從中醫界使用濃縮製劑以來，鮮見有評估濃縮製劑與傳統水煎劑在療效上相等性之研究。故臨床中醫師在使用濃縮製劑時，似無一定的準則與客觀依據。若僅依據藥廠之建議劑量是否可達與傳統水煎劑相等的口服吸收率與療效，是一個值得關注的研究課題。三黃瀉心湯出於金匱要略，包含大黃、黃連及黃芩，其苦寒瀉火，為治療熱盛吐衂証要方，為一常用之中藥方劑。近代藥理學研究顯示，三黃瀉心湯具抗病原微生物之作用，可用於急性肺炎、急性化膿性扁桃腺炎及眼部炎症等疾病，另外尚有治療缺血性腦血管疾病、鎮靜、降壓、降血脂、抑制大鼠胃潰瘍形成、保護胃黏膜、抑制胃酸分泌、抗發炎等作用。且此方目前亦於台灣進行抗癌之臨床試驗中。另外，組成此方之藥物大黃、黃連及黃芩均為富含多酚類成分之中藥，此些藥物及其成分亦多具抗菌、抗腫瘤、抗病毒、抗發炎、抗氧化等活性，因此三黃瀉心湯應具開發成為治療癌症、心血管疾病、抗SARS等相關疾病藥物之潛力。本計畫於93年度正進行三黃瀉心湯水煎劑及濃縮製劑，其中所含aloe-emodin、emodin、chrysophanol、rhein、baicalin、baicalein、wogonin、berberine等活性成分含量之分析。
關鍵字：水煎劑；濃縮製劑；三黃瀉心湯；生體可用率；人體；生體相等性
Relative Bioavailability of Bioactive Constituents Between Concentrated Herbal Formula and Traditional Herbal Decoction of San-Huang-Shel-Shin Tang
Yu-Chi Hou
China Medical University
At present, traditional decoction and commercial herbal extract are two dosage forms used in clinical Chinese medicine. While the only dosage form that can covered by Bureau of National Health Insurance is commercial herbal extract and thus costs a considerable part of National Health Insurance expenses. However, there are no reports concerning the bioequivalence between these two dosage forms. In order to provide the data base for clinical application, this study attempts to assess the bioequivalence between herbal concentrate and traditional decoction, and at least six commercial herbal extract will be purchased from the market. The contents of San Huang Xie Jin Tang (aloe-emodin, emodin, chrysophanol, rhein, baicalin, baicalein, wogonin and berberine) will be determined by HPLC methods established in our laboratory. The administrations of traditional decoction and commercial herbal extract will be carried out in a crossover design with one week interval for washout. Urine samples withdrawed at predetermined time points post administration are assayed for the concentrations of aloe-emodin, emodin, chrysophanol, rhein, baicalin, baicalein, wogonin and berberine and its conjugate metabolites with using our developed method, respectively. WINNONLIN is used for pharmacokinetic parameters and bioavailability calculations.
關鍵字：San Huang Xie Jin Tang；pharmacokinetics；bioavailabilities；metabolites
