不同包装材料对鼻炎清滴鼻液稳定性的影响

Effects of Different Packaging Materials on the Stability of Biyanqing Nasal Drop

目的:考察不同包装材料对鼻炎清滴鼻液质量稳定性的影响。方法:分别对鼻炎清滴鼻液的3种不同包装材料:聚乙烯(PE)瓶、聚丙烯(PP)瓶和聚酯(PET)瓶,进行加速和长期稳定性试验,观察滴鼻液基本性状和包材性质的变化,并采用HLPC法考察鼻炎清滴鼻液中醋酸泼尼松的含量变化。结果:PET瓶的性质优于PE瓶和PP瓶,其具有更高的耐热性和阻隔性,而且醋酸泼尼松在PET瓶中最稳定。结论:PET瓶作为鼻炎清滴鼻液的包装材料,能够保证药物质量稳定,是较理想的包材。

Objective： To study the effects of different packaging materials on the stability of Biyanqing nasal drop. Methods： The accelerated and long-term studies on three different packaging materials, including polyethylene （PE） bottles, polypropylene （PP） bottles and polyester （PET） bottles, Were carried out. The changes of basic characteristics and packaging material properties of nasal drop were observed. The content change of prednisone in Biyanqing nasal drop was studied by HPLC. Results： PET bottles had the best thermostability and barrier property when compared with PE and PP bottles. The content of prednisone acetate was the most stable in PET bottles. Conclusion： PET bottles are preferable packaging materials for Biyanqing nasal drop, which can ensure stable drug quality.