利用天然食材作為崩散劑之研究

The Research of Several Natural Edible Materials as a Disintegrant

澱粉是目前唯一仍大量使用的天然崩散劑。香菇、金針菇、黑木耳、白木耳、杏鮑菇及珊瑚菇是台灣傳統食材且相當美味，本研究將探討這些食材成為崩散劑的可能性。本研究所使用之實驗錠劑，利用hydrochlorothiazide當做模型藥物，用dibasic calcium phosphate做稀釋劑，加入澱粉或上述食材當作崩散劑，並以直接壓錠法製造。在酸鹼值1.2或6.8的溶媒中測定這些錠劑的崩散時間。崩散劑添加濃度對崩散時間的影響，則以添加白木耳當崩散劑的錠劑做研究。在酸鹼值1.2或6.8的環境中這些食材的膨脹體積及吸水能力也被研究，希望藉這些研究結果了解這些食材可以當崩散劑的機轉。崩散試驗的結果顯示出這些含食材錠劑的崩散時間（大部份低於二分鐘）遠小於空白錠的崩散時間（超過四十分鐘）。當這些食材先烹煮後再進行研磨時效果更好，尤其被烹煮處理過的白木耳，它的崩散時間最少。因此本實驗進一步用添加白木耳的錠劑測試，發現白木耳的添加濃度範圍很大，可以從百分之一到百分之十。從膨脹體積和吸水能力試驗中得知，這些食材的崩散能力和其膨脹能力及吸水能力有關：整體來說，他們的膨脹能力及吸水能力在中性的環境中表現得比在酸性環境中好，崩散時間和其在酸鹼值1.2或6.8溶媒中膨脹能力及吸水能力表現不一致，應是受稀釋劑的影響。

Starch is the only natural disintegrant which is still widely used today. Lentinula edodes （Berkeley） Pegler, Flammulina velutipes （Curt. Fr.） Sing, Auricularia polytricha, Tremella fuciformis, and Pleurotus eryngii are traditional Taiwanese food materials. They contain a lot of fiber and taste deliciously. They were investigated as a novel disintegrant in this study. The tablet contained hydrochlorothiazide, dibasic calcium phosphate, and each new material or starch respectively as the model drug, the bulking agent, and the disintegrant. The tablets were made by direct compression method. The disintegration time of these tablets in pH 1.2 or pH 6.8 medium was measured. The effect of disintegrant concentration on the disintegration time using Tremella fuciformis was studied. The swelling volume and hydration capacity of these materials in pH 1.2 or pH 6.8 medium were also studied to investigate the possible mechanisms of these materials to be used as a disintegrant. The result showed that the disintegration time of tablets containing each milled material （＜ 2 min in most materials） was much less than that of blank tablets （＞ 40 min）. The disintegration time of tablets was further decreased if each material was cooked before milling. Especially, the tablets containing cooked Tremella fuciformis （3W） had the least disintegration time and it can be used from one to ten percents. The disintegrating activity of these materials is related to their swelling and water hydration abilities as shown in the swelling volume and hydration capacity studies. Generally speaking their swelling and hydration capacity are better in neutral environment than in acidic environment. The discrepancy between disintegration time and swelling and hydration capacity in pH 1.2 or pH 6.8 medium may be due to the effect of bulking agent.