甲磺酸酚妥拉明片稳定性考察

On the Stability of Phentolamine Mesilate Tablets

目的 考察甲磺酸酚妥拉明片的稳定性。方法 甲磺酸酚妥拉明片在高温、高湿及光照条件下放置１０ ｄ ；４０ ℃，７５ ％ 湿度放置３ 个月；室温留样考察６ 个月，对其外观进行检查，对有关物质、溶出度和含量进行测定。结果 本品对光、热４０ ℃、高湿及空气稳定，对热６０ ℃和８０ ℃不稳定。结论 本品的稳定性较好，贮存时应密封置阴凉处，预计室温放置两年稳定。

Objective To observe stability of phentolamine mesilate tablets. Methods The Exterior, dissolution, related substances and assay of phentolamine mesilate tablets were measured under conditions of high temperature,high humidity and light radiation for 10 days;40℃,75% humidity for 3 months and under room temperature for six mouths. Results Phentolamine mesilate tablets were stable for light radiation,high temperature 40℃ and high humidity,and unstable for high temperature 60℃ and 80℃. Conclusion The tablets have good stability. Preserving in tight containers at controlled room temperature for two years, the tablets keep stable.