不同容器中复方碘滴鼻液的稳定性研究

Study on Stability of Compound Iodine Nasal Drops in Different Containers

目的考察复方碘滴鼻液在不同容器中的稳定性，筛选适合制剂的包装材料容器，确保制剂的稳定性，延长制剂的有效期，保证制剂质量。方法将复方碘滴鼻液分装于棕色、白色、透明的聚乙烯塑料小瓶（〈10 mL）,棕色、透明的玻璃瓶（500 mL），棕色、白色的塑料瓶（500 mL）中，在两种不同的贮存条件下（室温20-26 1及冰箱冷藏），分别在0，30，60d时测定不同包装容器中碘含量，比较不同材料包装瓶里的制剂稳定性。结果复方碘滴鼻液中的碘在玻璃瓶中较塑料瓶稳定；棕色材料比白色、无色透明的材料更稳定。结论实际操作中，复方碘滴鼻液制剂宜选用棕色塑料瓶包装，并应避光、密闭、阴凉处贮存。

Objective To investigate the stability of Compound Iodine Nasal Drops in different containers and to screen the packing ma- terial most suitable to the preparation for ensuring its stability and extending the period of validity. Methods The preparation was sub- packaged in three different material containers： the brown, white and transparent polyethylene plastic vials（〈 10 mL）; the brown and transparent glass bottles（500 mL） and the brown and white plastic bottles（500 mL）. To determine the content of Compound Iodine Nasal Drops stored under the two different conditions （the room temperature of 20X!？26t and the refrigerated temperature） within 0, 30,60 d. Then the stability of Compound Iodine Nasal Drops in different material containers were compared. Results Compound Iodine Nasal Drops was more stable in the glass bottle than in the plastic bottle ; the brown material was more stable than the white and transparent materials. Conclusion Compound Iodine Nasal Drops is recommended to be stored in the brown plastic （？） bottle in the practical operation, moreover, kept in dark, airtight and shade place.