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目的：探讨酮替芬鼻用喷雾剂的处方筛选及稳定性。方法：确定了酮替芬鼻用喷雾剂的处方，应用热加速试验研究了不同ｐＨ值喷雾剂的稳定性，并测定了不同ｐＨ值时富马酸酮替芬的油水分配系数。结果：富马酸酮替芬水溶液在不同ｐＨ值溶液中均有不同程度降解，在ｐＨ值为５．０时较为稳定。加入０．５％的亚硫酸氢钠则可大大提高富马酸酮替芬的稳定性。其正辛醇／水及氯仿／水的油水分配系数随着ｐＨ值增加而增加。结论：该制剂ｐＨ４～６时，制剂稳定性较好；当ｐＨ＞６时，制剂稳定性最差
Objective: To investigate the prescription screening and stability of ketotifen nasal spray. Methods: The formulations of ketotifen nasal sprays were determined. The thermal stability of sprays with different pH values was investigated by thermal accelerated test. The oil-water partition coefficient of ketotifen fumarate at different pH values was also determined. Results: Ketotifen fumarate aqueous solution in different pH solutions have different degrees of degradation, at pH 5.0 is more stable. Adding 0.5% sodium bisulfite can greatly improve the stability of ketotifen fumarate. Its octanol / water and chloroform / water oil-water partition coefficient increases with increasing pH value. Conclusion: The preparation has good stability at pH 4-6, when pH> 6, the preparation has the worst stability