摘要
目的对自制的阿奇霉素眼用即型凝胶进行稳定性考察,预测阿奇霉素眼用即型凝胶有效期。方法通过经典恒温法对阿奇霉素眼用即型凝胶的稳定性进行考察,观察其外观变化,测定其含量及降解产物的变化情况。结果阿奇霉素的降解反应为一级动力学反应,阿奇霉素眼用即型凝胶在2℃～8℃的条件下贮藏才较为稳定。结论将阿奇霉素眼用即型凝胶的贮藏条件规定为:在2℃～8℃的条件下冷藏,有效期暂定为24个月。
Objective To investigate the stability of homemade in Situ Forming Eye Gel of azithromy- cin and predict its expiry date. Methods The stability of in-Situ Forming Eye Gel of azithromycin was investi- gated by classic constant temperature test. The appearance, contents and degradation products of samples were observed and determined. Results The content change of azithromycin in in-Situ Forming Eye Gel was in ac- cord with the first order kinetics. Under 2℃-8℃ temperature, the homemade preparation was stable. Conclu- sion According to the accelerated test, the storage condition is set at 2℃-8℃ temperature and the tentative storage life was 2 years.
出处
《中国现代药物应用》
2010年第8期12-14,共3页
Chinese Journal of Modern Drug Application
关键词
阿奇霉素
眼用即型凝胶
稳定性试验
经典恒温法
Azithromycin
In Situ Forming Eye Gel
Stability test
Classic constant temperature
