复方薄荷脑滴鼻剂的稳定性研究

The stability study of Compound Menthol Nasal Drops

目的采用GC法对复方薄荷脑滴鼻剂的稳定性进行考察。方法色谱柱为HP-5(30m×320μm,0.25μm)弹性石英毛细管色谱柱,采用程序升温法,检测器温度为200℃,载气为N2,流速为25mL·min-1,进样口温度为250℃。参照《中国药典》2015年版四部通则9001对复方薄荷脑滴鼻剂进行影响因素实验、加速实验和长期实验。结果复方薄荷脑滴鼻剂在影响因素实验中,薄荷脑和樟脑的含量有较显著的变化,在加速实验和6个月的长期实验中薄荷脑和樟脑的含量均在标示量的90%以上。结论 GC法准确、重复性好,可用于复方薄荷脑滴鼻剂的稳定性研究。

Objective To establish stability study of Compound Menthol Nasal Drops by GC. Methods Sample solutions were injected onto an HP-5 capillary column （30 m×320μm,0.25μm）.The flame ionization detector temperature was 200 ℃,and the temperature was increased according to a program.Nitrogen as carrier gas was used with the flow of 25 mL·min^-1.The injector temperature was 250 ℃.Stress testing,accelerated stability testing and long-term testing of Compound Menthol Nasal Drops were studied according to General 9001of Chinese Pharmacopeia （Edition 2015,part 4）. Results The content of the menthol and camphor had obvious changes in the stress testing and both more than 90% in accelerated stability testing and long-term testing in 6 month. Conclusion This method is simple,accurate and reliable and can be used for the stability study of Compound Menthol Nasal Drops.