Objective To study the stability of Ozagrel Trometamol Concentrated Solution for Injection under the conditions of use or low-temperature freeze-thaw cycle to provide reference for its clinical use,storage and transportation.Methods The appearance,pH,related substances,insoluble particles,visible foreign matter and content were detected at 0,2,4,6,8,24 h after dilution of Ozagrel Trometamol Concentrated Solution for Injection respectively with 0.9％sodium chloride injection and 5％glucose injection.The appearance,pH,related substances,insoluble particles,visible foreign matter and content of Ozagrel Trometamol Concentrated Solution for Injection were investigated after 3 cycles of low-temperature and freeze-thaw,respectively.Results Whether Ozagrel Trometamol Concentrated Solution for Injection was mixed with 0.9％sodium chloride injection or with 5％glucose injection,all test items of the mixed solutions met the requirements within 24 hours,and there was no significant difference compared with 0 h.In addition,all test items of Ozagrel Trometamol Concentrated Solution for Injection met the specifications after 3 cycles of low-temperature and freeze-thaw,respectively,and there was no significant difference compared with 0 h.Conclusion The compatibility stability of Ozagrel Trometamol Concentrated Solution for Injection is fine within 24 hours after mixed with 0.9％sodium chloride injection or 5％glucose injection.The quality of Ozagrel Trometamol Concentrated Solution for Injection is not affected by short-term exposure to low temperatures(2～8 ℃)or freezing temperatures(-10--20 ℃).
关键词
奥扎格雷氨丁三醇/注射用浓溶液/配伍稳定性/低温试验/冻融试验
Key words
ozagrel trometamol/concentrated solution for injection/compatibility stability/low-temperature experiment/freeze-thaw experiment
维普
万方数据