雖然傳統中草藥近來受到廣泛注目，其應用卻常因為缺乏完整藥劑學
性質之研究而受到限制，本研究進行廣泛使用之中草藥-六味地黃丸新劑型
之探討。由於傳統中草藥含有許多成分以及複雜之製造程序，而對於其有
效主成分與賦形劑之間的交互作用之研究卻很少。首先，本研究利用示差
掃瞄卡計法（DSC），探討六味地黃丸主成分及三種中草藥製劑常用賦形劑
之不可配伍性。此外，以擠壓搓圓方法製備六味地黃丸新圓粒劑型，並利
用L16（215
）直交實驗設計法，對不同變因進行全面性的探討。將製得之
合適圓粒與常用之賦形劑HPMC壓製成錠劑，以探討六味地黃丸錠劑新劑
型製備之可行性。最後，以23
複因子設計來探討不同參數之圓粒及錠劑劑
型之溶離曲線。本研究中製備之六味地黃丸圓粒呈現出良好的可壓縮性，
經由壓錠過程形成較堅硬及緊密之結構，藥物有較緩慢之初始釋出速率，
並得到更好之安定性。藉由改變擠壓搓圓過程之不同變因，可得到合適之
六味地黃丸錠劑與圓粒劑型，這些新劑型可提供傳統中草藥在製備上另一
種選擇。

Traditional Chinese Medicine (TCM) has received broader attention recently, but the applications are limited due to the lack of more
complete study of their pharmaceutical properties. TCM often consists of numerous ingredients and generally involves a complicated
manufacturing process, but studies on the interaction of the active ingredients and excipients are rare. In this study, the development
of a novel dosage form of a widely utilized TCM (Liu-Wei-Di-Huang-Wan, LWDHW) was investigated. Firstly, Differential Scanning
Calorimetry (DSC) was used to study the incompatibility between the active ingredients of LWDHW and three excipients commonly used
in the manufacturing of TCM products. Secondly, a novel pellet dosage form of LWDHW was prepared using the extrusion-spheronization
method, and L16 (215
) orthogonal experimental design method was applied to perform an overall investigation of different variables.
The frequently used excipient, hydroxypropyl methylcellulose (HPMC), was compressed with resultant optimal pellets to investigate the
feasibility of a new LWDHW tablet dosage form. Finally, a 23
full factorial design was used in drug release studies to explore the dissolution
profile of pellets and tablets at various parameters. The pellets prepared in this study exhibited good compression properties and formed a
harder and tighter structure during the compression process, the resultant tablets showed a slower initial release rate and higher stability than
pellets. Optimal LWDHW pellet and tablet dosage forms were obtained by adjusting the variables of the extrusion-spheronization process.
The results from this study may provide a novel way of preparing LWDHW as well as other TCM dosage forms.