苯扎贝特缓释片的制备及体外释放研究

Preparation and in vitro Release of Bezafibrate Sustained Release Tablet

目的:制备苯扎贝特缓释片并考察其体外释放行为。方法:考察缓释材料羟丙甲纤维素(HPMC)E5LV和E50LV的不同比例及崩解剂羧甲基淀粉钠的不同用量对苯扎贝特缓释片体外释放度的影响,筛选确定最优处方,并考察其在氯化钠盐酸溶液、醋酸盐缓冲液、磷酸盐缓冲液及水4种介质中的溶出行为。结果:最优处方中,HPMC E5LV和HPMC E50LV的质量比为2∶1,羧甲基淀粉钠用量为4%,制剂在4种介质中的相似因子f2均大于50,体外释药符合一级动力学方程。结论:制备的苯扎贝特缓释片与参比制剂体外溶出行为相似。

Objective:To prepare Bezafibrate Sustained Release Tablet,and to investigate its release behavior in vitro.Methods:The different proportion of HPMC E5LV and HPMC E5L0V and the different dosage of sodium carboxymethyl starch on release in vitro was observed to screen the optimum formulation.In vitro drug release behavior of Bezafibrate Sustained Release Tablet was studied in four different pH values of the dissolution media.Results:The similar factor(f2)of the optimized formulation,which with the HPMC E5LV/HPMC E5L0V weight ration of 2∶1 and contend 4%of sodium carboxymethyl starch,in four different pH values of the dissolution media were all greater than 50,and the drug in vitro release behavior from sustained release tablets fits the first-class equation.Conclusion:The release behavior in vitro of Bezafibrate Sustained Release Tablet are similar with the reference preparation.