盐酸丙哌维林片稳定性及溶出度研究

Stability and dissolution study of propiverine hydrochloride tablets

目的：对盐酸丙哌维林片剂的稳定性和溶出度进行系统研究。方法：采用高效液相色谱紫外检测法测定影响因素试验、加速试验及室温留样条件下的稳定性和溶出度。结果：在各种考察条件下，样品的外观、含量、有关物质及溶出度均未发生明显变化，４５ｍｉｎ时溶出度在８５％以上。结论：盐酸丙哌维林片剂质量稳定，并具有较好的溶出性能。

OBJECTIVE:To investigate the stability and dissolution of propiverine hydrochloride tablets systematically. METHODS: HPLC UV was used to determine the stability and dissolution of the samples to be laid in the condition of severe test, accelerated test and long term storage test. RESULTS:Outward appearance, content, related substance and dissolution of the samples were not changed, and the dissolution rate was more than 85% in 45 min. CONCLUSION:The results show that propiverine hydrochloride tablets have good stability and dissolution.