中藥濃縮製劑與傳統水煎劑活性指標成分相對生體可用率之規劃研究

中國醫藥大學機構典藏 China Medical University Repository, Taiwan > 藥學院 > 藥學系暨碩博士班 > 研究計畫 > Item 310903500/13568

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题名:	中藥濃縮製劑與傳統水煎劑活性指標成分相對生體可用率之規劃研究
作者:	李珮端(Pei-Dawn Lee Chao);徐素蘭(Hsiu,Su-Lan);侯鈺琪(Hou,Yu-Chi)
贡献者:	藥學院藥學系
关键词:	濃縮製劑;水煎劑;枳殼;陳皮;柚皮甘;橙皮甘;生體可用率;Concentrate;Decoction;Zhiqiao;Chenpi;Bioavailability
日期:	2001-12-31
上传时间:	2009-09-01 16:24:54 (UTC+8)
摘要:	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。其中僅濃縮製劑為全民健保給付的劑型，因此濃縮製劑之應用佔健保費支出之比率甚為可觀。然而自從中醫界使用濃縮製劑以來，並未見有研究評估濃縮製劑與傳統水煎劑在療效上之相等性。本計畫之目的為評估濃縮製劑與傳統水煎劑中活性指標成分生可用率之相等性，以提供評估濃縮製劑與傳統水煎劑在療效上相等性之基礎數據。本計畫擬先於市場上採購至少六種不同廠牌之枳殼及陳皮單味濃縮製劑，以本實驗室建立的方法定量各產品中柚皮甘及橙皮甘之含量，並從中選出柚皮甘及橙皮甘含量最高的產品供健康志願者服用。男性健康志願者召募八至十名，以交叉設計方式分別服用柚皮甘及橙皮甘含量相等之濃縮製劑與傳統水煎劑，兩次服藥間隔一週以上。受試者分八個時段收集服藥後二十四小時間之尿液，以本實驗室建立的方法定量各尿液檢品中柚皮甘及橙皮甘主要代謝物之含量。由尿中回收代謝物的情形計算其藥品動力學參數及生體可用率，並以ANOVA 比較服用濃縮製劑與傳統水煎劑兩種劑型間柚皮甘及橙皮甘生體可用率之差異。此計畫之成果期望能提供臨床中醫師使用濃縮製劑時劑量決定及健保局藥品給付決策之參考，並提出中藥濃縮製劑之配方值得進一步檢討與改良之必要性。 There are two dosage forms usually used in clinical Chinese medicine, i.e. traditional decoction and herbal concentrate. Only the herbal concentrate is covered by health insurance. However, it seems that there were no studies to evaluate the bioequivalence between herbal concentrate and traditional decoction. In order to provide the data base for clinical application, this study attempted to assess the bioequivalence between herbal concentrate and traditional decoction. At least six commercial herbal concentrates will be purchased from the market. The contents of the antioxidant flavonoids (naringin, narirutin, naringenin, hesperidin and hesperetin) will be determined by HPLC methods established in our laboratory. The brand containing the highest content of marker constituents will be given to 8-10 healthy males. The administrations of traditional decoction and commercial herbal concentrate will be carried out in a crossover design.Urine will be collected in eight intervals until 24 hr. The major metabolites of the marker flavonoids will be determined by HPLC after enzymatic hydrolysis. The urinary data will be used to calculate the pharmacokinetics of the flavonoids and to compare the absorption rate between two dosage forms. Hopefully, the results of this project could provide useful information for clinical application of Chinese medicine. Moreover, it could also raise the necessity for the research and inprovement of manufactuing of Chinese herbal concentrates.
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