氯霉素醋酸泼尼松龙滴眼液有效期的预测

Forecasting of the Shelf-life of Chloramphenicol Prednisolone Acetum Eye Drop

目的:确定氯霉素醋酸泼尼松龙滴眼液(强氯滴眼液)有效期。方法:用HPLC法测定其含量,用光照法及初匀速法对强氯滴眼液稳定性进行考察。结果:强氯滴眼液中二成分经光照均有降解产物产生,其室温(20℃)有效期为12 d,冰箱保存(5℃)有效期37.5 d。结论:本制剂须冰箱保存并采用避光包装的条件下暂定有效期定为30 d。

Objective： To determine the shelf-life of hospital-prepared chloramphenicol prednisolone acetum eye drop. Method： The HPLC was applied to determine the content of chloramphenicol and prednisolone aeetum in the eye drop, and the accelerated testing approach and the illumination approach were applied to examine the stability of the eye drop. Result： After being illuminated, the chloramphenicol and prednisolone acetum turned into another effectless substance. In addition, at a room temperature of 20 ℃, the shelf-life of the eye drop was 12 days, and, when kept in the refrigerator at a temperature of 5 ℃, its shelf-life was 37. 5 days, Conclusion： When this preparation of chloramphenicol prednisolone acetum eye drop is kept in a refrigerator in photo-proof packing, its shelflife is tentatively set at 30 days.