本研究探討以材質A 製備Type NA、Type A、Type Am作新穎崩散劑的可能性及其崩散機制。以直打壓錠製備藥錠，乙醯胺酚 (Acetaminophen) 及氫氯苯嗪 (Hydrochlorothiazide) 為模式藥物，並分別以Di-Tab或乳糖為可溶性及不可溶性充填劑。所製備藥錠分別於純水、pH 1.2 鹽酸緩衝液、人工胃液、人工腸液等四種溶液進行崩散試驗。並在pH 1.2 鹽酸緩衝液、人工胃液、人工腸液 (不加酵素) 等不同的媒液進行溶離試驗。以材質A、 Ac-Di-Sol、 Primojel、 Polyplasdone XL等不同材質所製備的錠，進行吸水速率常數試驗，探討含不同材質的吸水動力學方程式。並比較材質 A及市售崩散劑於純水及pH 1.2 鹽酸緩衝液的動態及靜態膨脹試驗。希藉由吸水速率常數試驗及膨脹試驗探討材質 A可能的崩散機制。含材質A藥錠的崩散試驗和溶離試驗結果，表明有加材質A的藥錠，其崩散試驗和溶離試驗的結果，均較未加材質A的藥錠為佳。材質A 的Type Am所製備的錠，於吸水速率試驗所得的吸水動力學方程式，其吸水滯後時間較市售崩散劑為短，說明Type Am是明顯的毛細管作用。膨脹試驗結果說明材質A的膨脹體積，較市售崩散劑為小。由所做的實驗結果顯示，材質 A 作為崩散劑用途不受pH影響，材質A的崩散機制可能為毛細管和較弱的膨脹合併作用。 The purpose of this study is to investigate the possibility of A as a disintegrant and its disintegrating mechanism. Acetaminophen and hydrochlorothiazide were chosen as model drugs. Di-tab or lactose, representing the insoluble or soluble excipient separately, was used to make acetaminophen and hydrochlorothiazide tablets by direct compression method. The disintegration test was conducted in simulated gastric fluid, water, and simulated intestinal fluid. The dissolution test was conducted in pH 1.2 HCl buffer, simulated gastric fluid, and simulated intestinal fluid without enzyme. The water uptake test and the swelling study were conducted to explore the disintegrating mechanism of A. The water uptake test of A and commercial disintegrants was studied and the uptake kinetic equation was obtained. The intrinsic and the static swellings of A were measured in deionized water and 0.1 N HCl. The disintegration and the dissolution results show that tablets with A disintegrate and dissolve faster than those without A. The lag time of water sorption is the shortest for Type Am compared with commercial disintegrants, indicating A’s fine capillary action. The swelling of A is relatively small compared with commercial disintegrants. In conclusion, A may be used a disintegrant regardless of pH condition, primarily by its strong capillary and weak swelling actions.
