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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 investigate the stability of ethylenediamine diacetate and its compatibility with three common infusion solutions. Methods: The influencing factors (including light and high temperature test, 10d) and accelerated test (6 months) were respectively tested under the condition of packaging. The preparation was mixed with 5%, 10% glucose injection and 0.9% sodium chloride injection After compatibility study within 8.0h compatibility of the stability of the solution. The main indicators for the appearance of appearance traits, visible foreign body, pH value, the main drug content (peak area), the content of related substances and 5-hydroxymethyl furfural content. Results: Except for the slight increase of the related substances in the light test, no significant changes were observed in all the other tests. CONCLUSION: Ethylenediamine diacetate is better placed under dark conditions and its stability is better within 8.0 h after compatibility with the three common infusion solutions.