四物湯水煎劑與濃縮方劑之生物相等性研究

王靜瓊
臺北醫學大學藥學系
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。因其功能介於食補與藥用之間，健康人可以飲用作為補血藥膳，可以直接進行人體之生體可用率觀察。病人在中醫師的指示下，亦可作為中藥方劑，所以可以利用治療『卵泡發育不全症』之效用，作為藥效相等性之指標。因而，四物湯最適合用來探討水煎劑與濃縮製劑間的生物相等性關係。本研究全程預計完成，重點一：探討四物湯水煎劑與濃縮製劑，不同年齡層之健康女生口服後，生體可用率相等性研究評估。重點二：探討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。預期此研究將可以建立水煎劑與濃縮製劑間，服用劑量的關係，並確認水煎劑最佳煎煮方法，與濃縮製劑製程之改善，此結果對中醫師臨床應用、消費者之食用、中藥廠及中藥商將都會有助益。
關鍵字：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。

The human bioequivalence study between the decoction and concentrated herbal extracts of Si-Wu Tang

Ching-Chiung Wang
School of Pharmacy, Taipei Medical University
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. SWT can be used as the food supplement or drug usage. Health people usually used SWT to treat or prevent anemia, so we can employed SWT to monitor the human bioequivalence effects. 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. Taken together, SWT is the most suitable prescription to explore the bioequivalence between the decoction and concentrated herbal extracts. This study has two topics. First topic: explore the 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. In this study, we can establish the correlations between the dose-usage and decoction and concentrated herbal extracts. Our results are useful for people’s usage and the clinical applications of traditional Chinese medical doctors and pharmaceutical industry
關鍵字：Si-Wu Tang, decoction, concentrated herbal extracts, bioequivalence, ovarian follicular maldevelopment.