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目的 :考察影响阿司匹林亲水性骨架片体外释药的各种因素。方法 :以羟丙基甲基纤维素 (HPMC)为骨架材料 ,用粉末直接压片法制备缓释骨架片 ,并考察HPMC用量、粘度、粒度、制片方法、压片压力、片子大小及其它辅料对阿司匹林HPMC骨架片体外释药的影响。结果 :阿司匹林HPMC骨架片的体外释药均符合Higuchi方程。HPMC的用量、粘度和粒度、制法、片子大小对阿司匹林的释放速率均有显著性影响。湿法制片的释药比干法慢。阿司匹林的释药速率随HPMC粒度的减小、粘度和片子的增大而减慢。对压片压力影响的研究结果表明 ,阿司匹林HPMC骨架片的硬度范围不同时 ,影响有所不同。淀粉 ,PVP ,EC ,MCC的加入 (每片HPMC含量不变 )均加快阿司匹林的释放速率 ,且加入量不同时 ,释放速率间具显著性差异。结论 :HPMC用量、粘度和粒度、制片方法、片剂大小及其它辅料为影响阿司匹林骨架片释放速率的主要因素
OBJECTIVE: To investigate various factors affecting the in vitro release of aspirin hydrophilic matrix tablets. Methods: HPMC was used as matrix material to prepare sustained-release matrix tablets by powder direct compression method. The effects of HPMC dosage, viscosity, particle size, tabletting method, tabletting pressure, tablet size and others Effect of excipients on release of aspirin HPMC matrix tablets in. RESULTS: In vitro release of aspirin HPMC matrix tablets was in accordance with the Higuchi equation. HPMC dosage, viscosity and particle size, preparation method, the size of the tablet aspirin release rate had a significant impact. Wet tablet release slower than the dry method. Aspirin release rate with the HPMC particle size reduction, viscosity and film slowed down. The study of the effects of tabletting pressure showed that the impact was different when the hardness range of aspirin HPMC matrix tablets was different. The addition of starch, PVP, EC and MCC (unchanged HPMC content per tablet) accelerated the release rate of aspirin, and the release rate was significantly different at different dosage. Conclusions: The main factors influencing the release rate of aspirin matrix tablets were HPMC dosage, viscosity and particle size, tabletting method, tablet size and other excipients