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硫酸阿托品滴眼剂稳定性的考察
Study on the Stability of Atropine Sulfate Eye Drops
【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。
【Abstract】 Objective:To observe the active ingredients change of atropine sulfate eye drops in different environments and forecas- ting 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.
- 【文献出处】 中国药师 ,China Pharmacist , 编辑部邮箱 ,2008年04期
- 【分类号】R927.11
- 【被引频次】2
- 【下载频次】139