注射用头孢呋辛钠与氟康唑氯化钠注射液配伍稳定性考察

摘要

目的 研究不同温度、光照、放置时间下注射用头孢呋辛钠与氟康唑氯化钠的配伍稳定性.方法 采用高效液相色谱( HPLC )法考察,模拟临床用药的实际情况,分析不同温度、光照等变量因素对两者配伍稳定性的影响.温度为4℃和25℃,光照强度为2 500 Lx和无光,观察时间在配伍后的0,0. 5,1,2,4,6,8 h.考察内容包括外观、不溶性微粒、pH和含量测定等.结果 温度、光照、时间等均会影响配伍液的稳定性.光照对外观、pH、不溶性微粒的影响不大;从外观上看,25℃时药物在4 h时便出现逐渐变黄的趋势,4℃则6 h出现变化;从pH上看,25℃时在6 h时变化较大,4℃时在观察时间内变化不大;从不溶性微粒上看,观察时间内均呈透明;从含量测定上看,随着时间的推移,25℃、光照条件下的配伍液主药含量较25℃、无光条件下配伍液主药含量下降快;在同样避光的条件下,4℃配伍液主药含量随时间变化较小.结论 注射用头孢呋辛钠与氟康唑氯化钠注射液配伍,可能会受到光照、温度等影响,影响药物的外观、不溶性微粒、pH和主药含量,故应尽量保证在低温、无光照的条件下保存.%Objective To investigate the stability of the compatibility of cefuroxime sodium with Fluconazole Sodium Chloride Injection. Methods The stability of the compatibility of cefuroxime sodium and fluconazole and sodium chloride injection was analyzed by high performance liquid chromatography ( HPLC ) method, the main operation was to medicate and analyze simulation of the actual situation of clinical in different temperature, illumination and other factors in the impact of changes in the stability of the compatibility between the two drugs. The temperature was set at 4 ℃ and 25 ℃, and there were 2 cases of illumination:2 500 Lx and none. The observation time was after compatibility at 0, 0. 5, 1, 2, 4, 6, 8 h. The contents of the observation time included appearance, insoluble particles, pH examination and content determination, etc. Results The results showed that temperature, light, and time would affect the stability of the compatibility of cefuroxime sodium and fluconazole and sodium chloride injection. The illumination had little effect on the appearance, pH and insoluble particles. Judging from the appearance, at 25 ℃, the drug gradually turned yellow at 4 h;and at 4 ℃ the change began at 6 h. Judging from pH, at 25 ℃ the drug had large changes at 6 h;at 4 ℃ there was little change over time. Judging from the insoluble particles, the drug showed transparent during the observation time. Judging from the content determination, the main drug content at 25 ℃ and in light conditions decreased faster than those at 25 ℃ and without light conditions; in the same lightless conditions, the main drug content changed little over time at 4 ℃. Conclusion The compatibility of cefuroxime sodium with Fluconazole Sodium Chlo-ride Injection may be subjected to the influence of light, temperature and effects of the drug on the appearance, insoluble particles, pH and drug concentration. Therefore, we should try to ensure that stored at low temperature, illumination conditions, will ensure drug kept for a longer period of time.