非洛地平缓释片的制备及体外释放行为研究

Preparation and in vitro release behaviors of felodipine sustained-release tablets

目的制备非洛地平缓释片,并对其进行体外释放行为研究。方法以聚氧乙烯40氢化蓖麻油为增溶剂,羟丙基甲基纤维素(HPMC)和羟丙基纤维素(HPC)为缓释材料制备非洛地平缓释片。通过单因素对处方进行初步筛选,以正交试验筛选出最佳处方,考察自制制剂和参比制剂在不同释放介质中的释放行为,并进行f_2相似因子比较。结果选择HPC(JXF)用量为15%,HPMC(E50)用量为30%,HPMC(E10M)用量为10%时,制备的非洛地平缓释片与参比制剂在不同的释放介质中相似因子f_2均在50以上。结论自制非洛地平缓释片体外释放行为与参比制剂相似。

Objective To prepare felodipine sustained-release tablets and determine its in vitro release. Methods Polyoxyethylene 40 hydrogenated castor oil was used as the solubilizing agent, and HPMC and HPC were used as the sustained-release materials to prepare felodipine sustained-release tablets. The prescriptions were screened by single factors, and the best prescriptions were screened by the orthogonal test. The release behaviors of self-made preparations and reference preparations in different release media were investigated, and f2 similar factors were compared. Results When the selected amount of HPC(JXF) was 15%, HPMC(E50) dosage was30%, and HPMC(E10 M) dosage was 10%, the similar factor f2 of the prepared felodipine sustained-release tablets and the reference preparation in different release media were above 50. Conclusion The in vitro release behaviors of self-made felodipine sustained-release tablets are similar to those of the reference preparation.