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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

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【作者】 朱立平常明李淑芳

【Author】 Zhu Liping Chang Ming Li Shufang (Department of Pharmacy,Sino-Japanese Friendship Hospital,Beijing 100029,China)

【机构】 中日友好医院药学部中日友好医院药学部 北京 100029北京 100029

【摘要】 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。

【Abstract】 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 acetum in the eye drop,and the accelerated tes- ting 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.Conclu- sion:When this preparation of chloramphenicol prednisolone acetum eye drop is kept in a refrigerator in photo-proof packing,its shelf- life is tentatively set at 30 days.

  • 【分类号】R988.1
  • 【下载频次】59
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