粉末直接压片法制备盐酸丙哌维林片及其稳定性考察

摘 要 目的:优选盐酸丙哌维林片粉末直接压片法最佳制备工艺，并考察其稳定性。方法: 采用粉末直接压片法，以粉末休止角、片剂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良好，有效成分溶出速率高，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

Preparation and Stability of Propiverine Hydrochloride Tablets Prepared by Direct Powder Compression

ABSTRACT Objective: To optimize the preparation process of propiverine hydrochloride tablets by direct powder compression and investigate the stability. Method:The samples were prepared by direct powder compression and the quality was inspected using powder angle of repose, tablet friability and drug dissolution as the evaluation indices. Result:The optimal formula had promising powder fluidity and dissolution rate. The quality of the tablets was accorded with the relative requirements. After accelerated test of 6 months and storage at room temperature, the appearance, content, related substance and dissolution of the samples showed no significant change. Conclusion:The optimal formula and the preparation process are convenient, economical, time-saving and stable.