硫酸阿托品缓释片稳定性预测

Estimation of stability of atropine sulfate sustained-release tablets

目的:预测硫酸阿托品缓释片稳定性,为临床提供贮存期依据。方法:用经典恒温法预测其有效期,对供试品在强光照射和高湿等条件下观察其外观性状,测定其含量。结果:本品稳定性与温度有关,符合Arrhenius公式,但对高湿度不稳定,有效期暂定为2年。结论:本品不稳定,应制定有效期.并注意在干燥条件下贮存。

Objective：To estimate the stability of atropine sulfate sustained-release tablets, which tells its storage life for clinic. Methods： The storage life was determined with the method of classic constant temperature. Influencing factors including light radiation and high humidity on the stability of the samples were investigated. The assay and purity of the samples under different conditions were determined. Results： The stability of atropine sulfate sustained-release tablets was associated with the temperature, which was in consistence with Arrhenius equation, being unstable under the high humidity. This tablet may be stored for two years. Conclusions： Atropine sulfate sustained-release tablets is unstable, so a regulation of its storage life should be established, and it should be stored in a dry place.