注射用氨苄西林钠、酚磺乙胺的体外配伍稳定性考察

Compatible stability study of ampicillin sodium mixed with etamsylate

关键词:  氨苄西林钠  酚磺乙胺  配伍  稳定性

Key words:  ampicillin sodium for injection  etamsylate injection  compatibility  stability

摘要:

［目的］考察注射用氨苄西林钠、酚磺乙胺在0.9％氯化钠注射液中的配伍稳定性。［方法］用高效液相色谱法考察一定时间点配伍样品液中氨苄西林钠和酚磺乙胺的含量变化。［结果］两厂家4种交叉配伍溶液的酚磺乙胺峰面积，随时间延长呈上升趋势；而各样品液的氨苄西林钠峰面积亦随时间略减小，其中样品5峰形变化相对较小，0～4 h各时间点峰面积RSD为3.28％，样品6、7和8峰形有较大变化（出现氨苄西林的衍生物峰），峰面积变化亦较大。［结论］本实验结果表明，氨苄西林钠和酚磺乙胺在0.9%氯化钠注射液中配伍不稳定，临床不可配伍使用。

Abstract:

［Objective］To study the compatible stability of ampicillin sodium mixed with etamylate in normal saline injection solution. ［Methods］HPLC assay was performed for determining the content of ampicillin sodium and etamylate mixed injection solution. ［Results］The peak area of etamsylates was increased slightly in time-dependent manner. There was a little change in the peak area of sample 5, RSD of peak area was 3.28﹪from 0 to 4 h. There were some changes in the peak shape and the peak area of sample 6, 7 and 8. ［Conclusion］The mixed ampicillin and etamsylate injection N.S solution is not in good stability. The result suggests that mixed ampicillin and etamsylate N. S. injection solution should not be used in clinic.