右倍他米松磷酸钠注射液的制剂稳定性和配伍稳定性研究

Study on preparation stability and compatibility stability of Dexbetamethasone Sodium Phosphate Injection

目的:考察右倍他米松磷酸钠注射液的制剂稳定性和配伍稳定性。方法:通过影响因素试验、加速试验、长期试验和溶液配伍稳定性试验对其稳定性进行研究。结果:影响因素试验、加速试验和长期试验条件下分别放置10d、6个月和12个月,产品较为稳定。与0.9%氯化钠注射液、5%葡萄糖注射液或10%葡萄糖注射液配伍在考察的8h内稳定。结论:该制剂稳定性良好,可与0.9%氯化钠注射液、5%葡萄糖注射液或10%葡萄糖注射液配伍使用。

Objective：To study the stability of Dexbetamethasone Sodium Phosphate Injection.Methods：The stability of Dexbetamethasone Sodium Phosphate Injection was studied by influencing factor test, accelerated test, long-term test and solution compatibility stability test.Results：The prepared injection was stable in intluencing factor test of 10 days and accelerated test of 6 months and long-term test of 12 months respectively.It was stable in the compatibility solution with 0.9% sodium chloride injection or 5% glucose injection or 10% glucose injection in the test of 8 hours. Conclusion：The preparation is stable. It is compatible with 0.9% sodium chloride injection or 5% glucose injection or 10% glucose injection.