硫酸阿托品滴眼剂稳定性的考察  

Study on the Stability of Atropine Sulfate Eye Drops

作　　者：武夏明[1] 孙兆荣[2] 孝建华[2] 

机构地区：[1]山东大学药学院,济南250012 [2]泰山医学院附属医院

出　　处：《中国药师》2008年第4期425-427,共3页China Pharmacist

摘　　要：目的:观察硫酸阿托品滴眼剂在不同环境下有效成分的改变,预测该制剂的有效期。方法:采用HPLC法测定硫酸阿托品滴眼剂的含量,分别对该制剂进行不同酸度环境下考察、光加速试验、恒温加速试验、留样观察试验。结果:该制剂最适pH为3.5～5.5;对光敏感;室温下制剂的有效期为13个月。结论:该制剂酸性条件下稳定,储存应避光保存。Objective： To observe the active ingredients change of atropine sulfate eye drops in different environments and forecasting it＇ s expiration date. Method： The atropine sulfate eye drops was determined by HPLC and it＇ s stability was inspected in various pH by accelerated test of light and constant temperature and long-term. Result： The optimum pH for this preparation was 3.5 - 5.5 ;It was sensitive to light and instability;The expiration date was 13 months at room temperature. Conclusion： This preparation is stable in acidic condition ,it should be protected from light.

关 键 词：硫酸阿托品 制荆 稳定性 有效期 

分 类 号：TQ460.72[医药卫生—药物分析学]