硝苯地平骨架缓释片的处方研究

Study on the Formulation of Nifedipine Sustained-release Matrix Tablets

目的研究硝苯地平缓释片的处方工艺。方法通过单因素筛选,以释放度为指标,评价处方因素对缓释片释放行为的影响,通过相似因子法选择最优处方,并比较自制骨架缓释片与参比制剂包芯片的体外释放行为。结果羟丙甲纤维素的占比对硝苯地平缓释片的体外释放度影响最大,最优处方组成为:硝苯地平20mg、羟丙甲纤维素K4M80mg、乳糖24mg、微晶纤维素25mg、硬脂酸镁1mg,最优处方重现性良好。结论自制制剂与参比制剂在体外四种溶出介质中均相似,且与包芯片相比,制备工艺简单,易于产业化生产。

OBJECTIVE To study the formulation of nifedipine sustained-release matrix tablets. METHODS The dissolution was used as the evaluation index to investigate the factors that have a great influence on the release behavior of sustained-release tablets,and the optimal prescription was selected by the similarity factor method,and the in vitro release behavior was compared between the self-made sustained-release matrix tablets and the press-coated tablets. RESULTS The proportion of hypromellose in the matrix material had the greatest influence on the in vitro release of nifedipine sustained-releasetablets,the optimal prescription composition was:nifedipine 20mg,hypromellose K4M 80mg,lactose 24mg,microcrystalline cellulose 25mg and 1mg of magnesium stearate,the reproducibility of optimal prescription was good. CONCLUSION The self-made preparation and the reference preparation are similar in the four dissolution media in vitro,and compared with the press-coated tablets,the preparation process of self-made preparation is simple and easy to industrialize.