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目的:考察氯霉素地塞米松滴耳液热稳定性,预测其室温存放的有效期。方法:采用HPLC法测定氯霉素地塞米松滴耳液中氯霉素和醋酸地塞米松的含量;并以经典恒温法和t_(0.9)法对该制剂进行稳定性考察。结果:氯霉素和醋酸地塞米松的含量随温度升高和时间的延长呈线性下降,经典恒温法测得氯霉素和醋酸地塞米松在25℃的贮存期分别为110 d和321d,以t_(0.9)法求得氯霉素和醋酸地塞米松在25℃的贮存期分别为108 d和297 d。结论:氯霉素地塞米松滴耳液的有效期暂定为3个月。
OBJECTIVE: To investigate the thermal stability of chloramphenicol dexamethasone ear drops and to predict the validity of its storage at room temperature. Methods: The content of chloramphenicol and dexamethasone acetate in chloramphenicol dexamethasone ear drops was determined by HPLC method. The stability of the preparation was investigated by classical thermostat method and t_ (0.9) method. Results: The content of chloramphenicol and dexamethasone acetate decreased linearly with the increase of temperature and time, and the storage period of chloramphenicol and dexamethasone acetate at 25 ℃ was 110 d and 321 d respectively, The t_ (0.9) method was used to determine the shelf life of chloramphenicol and dexamethasone acetate at 25 ℃ for 108 d and 297 d, respectively. Conclusion: The validity of chloramphenicol dexamethasone ear drops is tentatively scheduled for 3 months.