摘要
目的：考察各种影响硫酸奎尼丁（ＱＳ）亲水性骨架片体外释药的因素。方法：以羟丙基甲基纤维素（ＨＰＭＣ）为骨架，用湿颗粒法将ＱＳ制成缓释片，考察ＨＰＭＣ的用量、粘度、粒度、制法、制片压力、片子大小及其它辅料对硫酸奎尼丁ＨＰＭＣ缓释骨架片体外释药的影响。结果：硫酸奎尼丁ＨＰＭＣ缓释骨架片体外释药速率均很好地符合Ｈｉｇｕｃｈｉ方程（ｒ＞０．９９９）。ＨＰＭＣ用量、粘度和片子大小对硫酸奎尼丁释放速率均有显著影响，为主要影响因素。ＨＰＭＣ用量越大，释药越慢；片子越大，释药越慢；粘度越大，释药越慢，但当粘度达一定程度后，其释药速率的改变不明显。ＨＰＭＣ的粒度和制片压力对硫醚奎尼丁释放的影响不明显。粉末直接压片法比颗粒法释药快。聚维酮（ＰＶＰ），Ｌ－羟丙基纤维素（Ｌ－ＨＰＣ），微晶纤维素（ＭＣＣ），乙基纤维素（ＥＣ）的加入均可加快硫酸奎尼丁的释放速率，但Ｌ－ＨＰＣ和ＭＣＣ在所实验的范围内，用量的变化对其影响不显著。结论：ＨＰＭＣ用量、粘度和片子大小为影响硫醚奎尼丁ＨＰＭＣ骨架片释放速率的主要因素。
OBJECTIVE:To study the factors influencing quinidine sulfate(QS)release rate from HPMC hy-drophylic matrix tablet.METHODS:The extended matrix tablet was compressed by wet method with QS as a mod-el drug.The effect of the amount,viscosity and particle size of hydroxyporpylmethylcellulose(HPMC),preparingmethod,compression pressure,tablet size and the addition of excipients such as polyvinylpyrrolidone(PVP),L-Hy-droxypropylcelulose(L-HPC),microcrystalline cellulose(MCC)and ethvl cellulose(EC)on the QS release rate fromthe matrix tablets were observed.REsULTs:In all cases,the plot of drug released against time1/2 produced astraight line.The QS release rate was decreased with increasing the amount,vicosity of HPMC and the tablet size,but the effect of viscosity was insignificant between Kl5m and Kl00m,The effects of the particle size of HPMC andcompression pressure were not significant.The QS release from the tablet made by direct compressed method wasfaster than the wet method.The addition of PVP,L-HPC,MCC and EC could quickened the release but the changesof the amount of L-HPC and MCC in this test range insignificantly affected drug release.CONCLUSION : Theamount and viscosity of HPMC as well as the tablet size are the main factors on QS release rate from HPMC ex-tended matrix tablet.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1996年第12期727-730,共4页
Chinese Pharmaceutical Journal
关键词
硫酸奎尼丁
羟丙基
甲基纤维素
骨架片
缓释
quinidine sulfate ,hydroxypropylmethylcellulose ,matrix tablet ,sustained release
