喜炎平注射液与溶媒配伍稳定性研究

Compatible stability of Xiyanping Injection with solvents

目的:研究不同用量的喜炎平注射液与5%葡萄糖注射液和0.9%氯化钠注射液配伍药液的稳定性。方法:将喜炎平注射液与5%葡萄糖注射液和0.9%氯化钠注射液分别按1:250;2:250;5:250;10:250;20:250;30:250的比例配伍后,考察配伍后0-6h内药液的性状、pH值、不溶性微粒、主要成分磺化物E含量、液相指纹图谱的变化情况。结果:配伍药液的性状、pH值、主要成分磺化物E含量、液相指纹图谱相似度在配伍后的0-6h内没有显著差异,而不溶性微粒数量有较大变化。结论:喜炎平注射液与5%葡萄糖注射液和0.9%氯化钠注射液配伍4h内比较稳定,为了保证临床用药安全建议配伍使用控制在4h内,且喜炎平注射液用量不宜大于20mL。

Objective： To investigate the compatible stability of Xiyanping Injection in different dosages with 5% glucose injection and 0.9% sodium chloride injection. Methods： The changes before and after compatible application of Xiyanping Injection with 5% gucose injection and 0.9% sodium chloride injection （1：250, 2：250, 5：250, 10：250, 20：250, 30：250） on color, clarity, pH, main ingredients and atlas of HPLC were determined. Results： There were no difference in the color, clarity, pH, the main ingredients and liquid tinge rprints of the mixture solutions, but the insoluble particles in them showed significant difference within 6h. Conclusion： Xiyanping Injection is compatible in different concentrations with 5% glucose injection or 0.9% sodium chloride injection within 4h. It should be used with in 4h in practise, and the dosage of Xiyanping Injection should be less than 20mL every day.