朱立平 常明 李淑芳 (中日友好医院药学部 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37.5d。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30d。
关键词 氯霉素; 醋酸泼尼松龙; 光照法; 有效期
中图分类号：R944.1+2
文献标识码：A
文章编号：1008-049X(2007)04-0342-02
Forecasting of the Shelflife of Chloramphenicol Prednisolone Acetum Eye Drop
Zhu Liping, Chang Ming, Li Shufang(Department of Pharmacy, SinoJapanese Friendship Hospital, Beijing 100029，China)
ABSTRACT Objective: To determine the shelflife of hospitalprepared 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 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 shelflife of the eye drop was 12 days, and, when kept in the refrigerator at a temperature of 5 ℃, its shelflife was 37.5 days.Conclusion: When this preparation of chloramphenicol prednisolone acetum eye drop is kept in a refrigerator in photoproof packing, its shelflife is tentatively set at 30 days.
KEY WORDS HPLC, chloramphenicol, prednisolone acetum shelflife
参 考 文 献
1 林建设，白乐溪.盐酸加替沙星滴眼液的制备及质量控制［J］.中国药师，2006,9(5):444-445
2 常明,李靖,李淑芳.高效液相色谱法同时测定强氯滴眼液中2组分的含量［J］.中国药房，2005.16(14):1106-1107
资料来自:中国药师-专业站 |