硝苯地平缓释片的制备及其体外释放度考察

Study on Preparation and In-vitro Release of Nifedipine Sustained Release Tablets

目的:制备硝苯地平(NFP)缓释片并考察其体外释放度。方法:以聚甲基丙烯酸甲酯/聚丙烯酸乙酯(PMMA/PEA)为缓释材料制备缓释片;采用紫外分光光度法测定NFP含量并计算溶出度;设计正交试验,以释放度为基础设计的综合评分值为指标优选处方。结果:筛选最优处方为羧甲基淀粉钠50%、PMMA/PEA40%、聚乙烯吡咯烷酮50%。累积溶出百分率8h>70%。结论:所制备缓释片的工艺合理,且具有良好的缓释效果。

OBJECTIVE： To prepare nifedipine sustained - release tablets and to study its in vitro release activity. METHODS： Polymethl methacrylate/polyethl acrylate （PMMA/PEA） was used as sustained- release material and orthogonal experiment used as test method to optimize prescription. The absorbency was determined with ultraviolet spectrophotometer in 237nm wave. RESULTS： Screening optimal prescription： sodium carboxyme- thyl starch 50% PMMA/ PEA 40%, polyvinylpyrrolidone 50%. CONCLUSION： The sustained- release tablet thus prepared is proper in technique and good in release effect.