粉末直接压片法制备硝苯地平片及其稳定性考察

目的 优选硝苯地平片粉末直接压片法的最佳制备工艺。方法 采用正交设计筛选硝苯地平片直接压片处方，以休止角、脆碎度及溶出度为评价指标，制备样品并进行质量考察。结果 所选处方粉末流动性好，药物溶出速率高（60 min时溶出度达到95%以上），各项指标均符合规定。经6个月加速及室温留样考察，样品的外观、含量、有关物质及溶出度均未发生明显变化。结论 优选的处方工艺操作简便、经济、生产周期短，制备的产品质量稳定，适合产业化生产。

Preparation and stability of nifedipine tablets by direct powder compression

Objective To optimize the preparation process of nifedipine tablets by direct powder compression.Methods The formulation of nifedipine tablets was optimized by orthogonal experiment design with angle of repose,friability and dissolution as evaluation indexes.The samples were prepared and their quality was inspected.Results The selected formulation had promising powder fluidity and drug dissolution rate which reached more than 95% in 60 min.The quality of the tablets was accorded with the relative requirements.After 6 months of accelerated test and storage at room temperature,the appearance,content,related substance and dissolution of the samples had no significant change.Conclusion The selected formulation and process were characteristic of convenient operation,economy,short production cycle,stable product quality,and was suitable for industrialized production.