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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

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【作者】 武夏明孙兆荣孝建华

【Author】 Wu Xiaming (School of Pharmaceutical Science of Shandong University,Jinan 250012,China); Sun Zhaorong Xiao Jianhua (Affiliated Hospital of Taishan Medical College)

【机构】 山东大学药学院泰山医学院附属医院

【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.

【关键词】 硫酸阿托品制剂稳定性有效期
【Key words】 Atropine sulfatePreparationStabilityExpiration date
  • 【分类号】R927.11
  • 【被引频次】2
  • 【下载频次】139
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