六味地黃散品質精緻化可行性與藥劑相等性評估

余建志
中國醫藥大學
本計劃以六味地黃散為模式藥物。透過低賦形劑的作為，整體製程僅以低於5%總重之天然多醣聚合物包衣進行包覆，不另加入其它賦形劑，提高濃縮倍數減少服用量。天然多醣聚合物包衣可以降低低賦形劑製劑之吸潮能力，具有提升製劑之安定性、隔阻濃縮中藥的苦味與提高產品的接受度等優點。計畫中藉比表面積效應對等重之不同藥物型式之天然多醣聚合物膜衣使用量的影響。並分別計算粒徑大小分佈、粉體性質及密度、粒子間空隙率與粉體流動速率。了解藥物體積縮小的原因及其可行性，將中藥製劑精緻化，成品量縮小，以達服藥簡便化的目的。最後，與市售六味地黃散濃縮製劑比較，證實新製成之藥劑與傳統舊有製藥方法之藥劑相等性與生體相等性。可以此為基礎進行多種週邊產品開發及應用。低賦形劑製劑開發可以提昇國內濃縮製劑水準，對中藥製劑廠商具有一定之啟發作用。也可以透過一般賦形劑稀釋調整、製造符合市場需求濃縮倍數之產品，濃縮倍數的標準化得以建立。
關鍵字：六味地黃散；天然多醣聚合物；吸潮；安定性

Assessment of Pharmaceutical Equvlence and Quality fineness of Low-Excipient Liou-Wei-Di-Huang Powder Dosage

YU, Chien-Chih
China Medical University
The purpose of this study is to reduce the percentage of excipients in a given dosage, so as to benefit the consumer with a higher concentration of medicine. We chose Liu-Wei-Di-Huang powder (LWDHP) as our model drug in the research process. To achieve our goal, we used natural polysaccharide polymer film (NPPF), which makes up only 5% of the total weight in the manufacturing process. If a higher percentage of excipients are used, the ratio of excipient to medicine will increase to the disadvantage of the consumer. The benefits of using NPPF are numerous, it inhibits the moisture absorption of a low-excipient dosage, it enhances stability and it also contains the bitter taste of concentrated herbal medicine, raising it acceptability. In order to understand the influence of NPPF, we tested the specific surface, particle size distribution, powder property, density, space between the particles and the powder flow rate of various dosage types. Our ultimate goal was to access and understand how we can change the form of the dosage, to make it as compact and easy to use as possible. Finally, we compared our samples with the LWDHP samples available on the market and the pharmaceutical equivalence and bioequivalence will be demonstrated. Furthermore, bases on this study could be converted and adapted into many other related products and applications.
關鍵字：Liu-Wei-Di-Huang powder；polysaccharide polymer film；moisture absorption；stability