摘要
目的:考察注射用二乙酰氨乙酸乙二胺的稳定性及与临床3种常用输液的配伍稳定性。方法:对制剂在包装条件下分别进行影响因素试验(包括光照和高温试验,10d)和加速试验(6个月);将制剂与5%、10%葡萄糖注射液及0.9%氯化钠注射液配伍后考察8.0h内配伍液的稳定性。主要考察指标为外观性状、可见异物、pH值、主药含量(主峰面积)、有关物质含量和5-羟甲基糠醛含量等。结果:除光照试验中有关物质含量稍有增加外,其余各项试验中各考察指标均未见明显变化。结论:注射用二乙酰氨乙酸乙二胺在避光条件下放置稳定性较好,其与3种常用输液配伍后8.0h内性质较稳定。
OBJECTIVE： To study the stability of ethylenediamine diaceturate（EDD） for injection and compatible stability of 3 kinds of clinically common infusions. METHODS： The experiement of influencing factors （including light, high temperature, 10 days） was carried out meanwhile the accelerated test （6 months） was performed for the preparation under the condition of being packaged; the stability of EDD in 5% glucose injection, 10% glucose injection or in 0.9% sodium chloride in- jection within 8.0 h were observed. The major outcome measures were appearance, visible foreign substances, pH value, contents of principal agent （area of the chief peak）, the relative substances and 5-hydroxymethyl furfural, etc. RESULTS： No marked change was noted for all the outcome measures except a slight increase of the content of the related substances in the light exposure test. CONCLUSION： EDD for injection stored away from light at room temperature shows good stability, and it is stable within 8.0 h after mixing with 3 kinds of common infusions.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第28期2199-2200,共2页
China Pharmacy
关键词
注射用二乙酰氨乙酸乙二胺
影响因素试验
加速试验
葡萄糖注射液
氯化钠注射液
配伍
稳定性
Ethylenediamine diaceturate for injection
Experiment on influencing factors
Accelerated test
Glucose injection
Sodium chloride injection
Compatibility
Stability
