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題名 | 四物湯水煎劑與濃縮方劑之生物相等性研究=The Human Bioequivalence Study between the Decoction and Concentrated Herbal Extracts of Si-Wu Tang |
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作者 | 王靜瓊; Wang, Ching-chiung; |
期刊 | 中醫藥年報 |
出版日期 | 20141200 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(32)1-(32)32 |
分類號 | 414.51 |
語文 | chi |
關鍵詞 | 四物湯; 水煎劑; 濃縮製劑; 生物相等性; 生體可用率; 卵泡發育不全症; Si-Wu Tang; Decoction; Concentrated herbal extracts; Bioequivalence; Ovarian follicular maldevelopment; |
中文摘要 | 研究目的:水煎劑是傳統的中藥劑型之一,隨著製藥技術的進步, 1963年開始有了中藥濃縮製劑,但兩種劑型間的生物相等性,卻鮮少有相關之科學論文。因此本研究選擇被國人常食用的四物湯,作為研究的首要方劑。健康人可以飲用作為補血藥膳,因此以治療『卵泡發育不全症』之效用,作為藥效相等性之指標。探討水煎劑與濃縮製劑間的生物相等性關係。 研究方法:1. 將四物湯水煎劑與濃縮製劑,給予不同年齡層之健康女生口服後,進行阿魏酸於體內生體可用率相等性研究評估。2. 將四物湯水煎劑與濃縮製劑,給予『卵泡發育不全』之不孕症婦女口服後,藥效相等性研究評估。 結果與討論:水煎劑與濃縮製劑在含等量阿魏酸的情況下,濃縮製劑( 18克)之生體可用率比水煎劑 (135 mL)高,且水煎劑較易受人的年齡而影響其吸收,其最大血中濃度(Cmax)及曲線下面積 (AUC)皆小於濃縮製劑,因此依曲線下面積結果顯示,在服用 180min內,具有相同阿魏酸血中濃度之含量下,水煎劑( 170mL/日)與濃縮製劑( 18克/日),對卵泡發育不全的婦人皆有改善。顯示一半的水煎劑日服量,與濃縮製劑的日服量具有相同作用,建議未來應針對濃縮製劑及水煎劑之日服量進一步討論。 |
英文摘要 | AIM: Decoction is one formulation of traditional Chinese medicines. Following the advancement of pharmaceutical technology, the concentrated herbal extracts became popular since 1963. However, few studies had reported the bioequivalence between the decoction and concentrated herbal extracts. Thus, we choose the Si-Wu Tang (SWT), the widely used traditional Chinese prescription, as our target to explore the bioequivalence differences. Health people usually used SWT to treat or prevent anemia, and Traditional Chinese medical doctor usually used SWT to treat the patients who are diagnosed as ovarian follicular maldevelopment, so SWT can be used to evaluate the pharmacological bioequivalence. METHOD: First topic: explore the ferulic acid bioequivalence effects of SWT which are presented as decoction or concentrated herbal extracts forms in different age health women. Second topic: explore the pharmacological bioequivalence of different forms of SWT in ovarian follicular maldevelopment patients. RESULTS & DISCUSSION: The dose-usage of SWT-decoction (135 mL) and concentrated herbal extracts (18 g) was control at the same amount of ferulic acid. The results showed the bioavailability of SWT-concentrated herbal extracts was better than SWT-decoction. When ovarian follicular maldevelopment patients took SWT-decoction (170 mL/day) or concentrated herbal extracts (18g/day) at the dosage of the same AUC, their symptom all were improved. In according to the results, we suggested the effects of half daily dose of SWT-decoction was the same as daily dose SWT-concentrated herbal extracts in clinical. We suggest the daily dose of SWT-decoction and concentrated herbal extracts should be discussed in future. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。