粉末直接压片法制备盐酸丙哌维林片及其稳定性考察  

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

作　　者：欧阳百发 刘春平 全向阳 

机构地区：[1]康美药业股份有限公司,广东普宁515300 [2]康美药物研究院有限公司

出　　处：《中国药师》2013年第3期351-354,共4页China Pharmacist

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。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.

关 键 词：盐酸丙哌维林 粉末直接压片法 稳定性 制备工艺 

分 类 号：R944.4[医药卫生—药剂学]