摘要
目的 :探讨在高温 (50℃～70℃ )和室温 ((20±1)℃ )下乳酸环丙沙星注射液与甲硝唑葡萄糖注射液 (甲硝唑G)配伍的稳定性。方法 :采用紫外分光光度法测定环丙沙星和甲硝唑的含量 ;用经典恒温法、留样观察法考察环丙沙星与甲硝唑G配伍液的含量、pH值及外观变化。结果:环丙沙星、甲硝唑的线性范围分别为1 00～10 02μg/ml、2 01～20 08μg/ml ;平均回收率分别为(101 30±4 28) %、(99 58±1 63) % ;70℃、8h内的热分解产物不干扰测定。高温、8h内的恒温加速试验以及室温、0～120h内的留样观察结果表明 ,环丙沙星与甲硝唑在配伍前、后药物残存率均大于95 % ;pH值、外观均无明显变化。结论 :环丙沙星与甲硝唑以5 %葡萄糖为溶媒 ,在高温、8h内和室温、120h内均稳定 ,可以配伍应用。
OBJECTIVE:To study the stability of mixture of ciprofloxacin injection and metronidazole in glucose injection at high temperature(50℃～70℃)and at room temperature((20±1)℃)storage METHODS:UV-spectrophotometry method was used for determining the contents of ciprofloxacin and metronidazole The changes in the content,pH value and appearance were observed by classical constant-temperature experiment and room temperature storage RESULTS:The linearity ranges for ciprofloxacin and metronidazole were 1 00～10 02μg/ml and 2 01～20 08μg/ml;the average recoveries were(101 30±4 28)% and(99 58±1 63)%,respectively The heat decomposition products at 70℃ for 8 hours did not interfere with the assay The relative contents of ciprofloxacin and metronidazole were more than 95% and there were no significant changes of the pH value and the color with accelerating experiment for 8 hours at 50℃～70℃ and for 120 hours at (20±1)℃ CONCLUSION:We found that admixture of ciprofloxacin with metronidazole in glucose solution was stable at high temperature for 8 hours and at room temperature for 120 hours Ciprofloxacin injection was compatible with metronidazole in glucose injection
出处
《中国药房》
CAS
CSCD
2002年第8期494-495,共2页
China Pharmacy
