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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 investigate the various factors that affect the in vitro drug release of quinidine sulfate (QS) matrix tablets. Methods: The hydroxypropyl methylcellulose (HPMC) was used as the matrix and the QS was made into sustained-release tablets by wet granulation method. The effects of dosage, viscosity, particle size, preparation method, tabletting pressure, Effect of Quinidine HPMC Sustained Release Matrix Tablet in. Results: In vitro release rates of quinidine HPMC sustained-release matrix tablets were in good agreement with the Higuchi equation (r> 0.999). HPMC dosage, viscosity and film size have a significant effect on the release rate of quinidine sulfate, which is the main influencing factor. The higher the dosage of HPMC, the slower the drug release. The bigger the tablet, the slower the drug release. The higher the viscosity, the slower the drug release. However, when the viscosity reaches a certain level, the release rate of the drug is not obvious. The effect of HPMC particle size and pressure on the release of quinidine was not obvious. Direct compression powder method than the particle method to release drugs faster. Povidone (PVP), L-HPC, MCC and EC could accelerate the release of quinidine sulfate, but L -HPC and MCC within the experimental range, the amount of change has no significant effect on it. Conclusion: The amount of HPMC, the viscosity and the size of the tablets are the main factors influencing the release rate of quinidine HPMC matrix tablets.