余建志 中國醫藥大學 

本計劃以羌活為模式藥物。將羌活藥材打碎為40~60 mesh粗粉，投入超臨界CO2流體萃取裝置的1 L萃取釜中，添加無水乙醇作為夾帶劑，先靜置60 mins，在萃取溫度為60-70℃、萃取壓力為200～600 bar、CO2流量為20～30 L/h的條件下萃取120～180 mins，即為羌活之超臨界抽提物，配合固體分散技術水溶性載體(如洋菜膠，PVP和 beta 環糊精)，經過噴霧乾燥後，使中藥分子分布於載體中，最後製成超臨界固粉分散加壓顆粒。提高低極性藥物溶解度具體可行。 中藥浸膏進口可行性評估有其必要性。中藥浸膏若可做為原料藥使用，等同將濃縮製劑前段製程外包，將可以減除前段的打碎，萃取，濃縮等製程，可以大幅降低原料，設備與人力成本，甚至讓廠商專注在技術和品質的提升，優點不少。但目前所收集的資料與訪談結果似乎都不支持以浸膏入藥，主要是憂慮品質與管理困難。 

關鍵詞：羌活，超臨界抽提，固體分散技術，中藥浸膏進口可行性評估 

The Solid Dispersion Formulations Development of Notopterygii Rhizoma et Radix (2-1) Chien-Chih Yu China Medical University This project takes qiang huo (Notopterygii Rhizoma et Radix) as model drug. Cut the qiang huo herbal to 40~60 meshes pieces. Put the pieces into 1 L superfluid extract container, with the anhydrous ethanol used as the modifier, and then stand for 60 minutes. Extract under the temperature of vessel 60-70℃, pressure 200-600 bars and CO2 flow rate 20~30 L/hr for 120~180 minutes to get the superfluid extract (SFE) of qiang huo. Treating the SFE of qiang huo.with the water carrier (such as agar, PVP and beta-cyclodextrin) of solid dispersion technique, and then dry it with spray dryer to make the Chinese medicine molecule disturb in the carrier, then pressurize the powder to be granule. Improve the solubility of low polarity drug is feasible. It is necessary to estimate the feasibility of importing Chinese herbal extract (CHE). If CHE is allowed to be used as API, which make the front-end process of concentrated engineering of preparations outsource, then the manufacturing process like pieces, extraction and concentration before granule can be cut out. It will lead to the cost down of raw material, instruments and labor, and maybe induce the better control and upgrade of skill of the manufacturers, which provides a lot of advantages. But from the latest data and results of interview, do not seem to support the use of importing CHE, due to the quality assurance and the difficulty of controlling mainly.