摘要
目的:通过影响因素试验和配伍稳定性试验考察自制布洛芬注射液的稳定性。方法:以精氨酸作为助溶剂,与布洛芬按1︰1摩尔比配制布洛芬注射液;通过影响因素试验(强光、高温和冻融试验),考察注射液稳定性;与0.9%氯化钠注射液和5%葡萄糖注射液配伍,考察24 h内的配伍稳定性。结果:制得的布洛芬注射液无色澄明,pH值在7.8左右;经影响因素试验考察,各指标无明显变化;配伍稳定性实验结果显示,与两种输液配伍后24 h内,配伍液外观和pH值均无明显变化,布洛芬含量基本没有变化,有关物质检查合格。结论:制备的布洛芬注射液经影响因素考察稳定性良好,与两种输液在25℃、24 h内配伍稳定。
Objective： To prepare and study the stability of ibuprofen injection with stress tests and compatibility test.Methods： Prepare ibuprofen injection with arginine as the solubilizing agent.Investigate the stability of the injection with highlight（4500 lx±500 lx）,high temperature（60℃） and repetitive freeze-thawing tests.The contents of ibuprofen injection in two mixed solution within 24 hours were detemined by HPLC,and the appearance and pH value of the mixed solutions were also examined.Results： Ibuprofen injection was colorless and clear.No significant change was found in appearance,pH,content of ibuprofen injection and related substance after the stress tests or being mixed with two infusions.Conclusion： Ibuprofen injection had a good stability in stress conditions and a good compatibility with two infusions at 25℃ in 24 h.
出处
《药学与临床研究》
2011年第2期186-188,共3页
Pharmaceutical and Clinical Research
基金
国家科技支撑计划(2008BAI55B03)
新制剂与新释药系统技术平台重大专项(2009ZX09310-004)
