奥扎格雷氨丁三醇注射用浓溶液使用中及低温冻融稳定性研究  

Stability Study on Ozagrel Trometamol Concentrated Solution for Injection under Conditions of Use or Low-temperature Freeze-thaw Cycle

作　　者：姚贺东 吴思琴 邢晓峰 刘志华 张若明 陈震[1] YAO He-dong;WU Si-qin;XING Xiao-feng;LIU Zhi-hua;ZHANG Ruo-ming;CHEN Zhen(College of Pharmacy,Zhengzhou University,Zhengzhou 450001,China;Wuhan Hengxinyuan Pharmaceutical Co.,Ltd.,Wuhan 430206,China)

机构地区：[1]郑州大学药学院,河南郑州450001 [2]武汉恒信源药业有限公司,湖北武汉430206

出　　处：《食品与药品》2024年第1期1-6,共6页Food and Drug

摘　　要：目的 考察奥扎格雷氨丁三醇注射用浓溶液使用中及低温、冻融稳定性,为其临床使用、贮藏和运输提供参考。方法 奥扎格雷氨丁三醇注射用浓溶液分别采用0.9%氯化钠注射液和5%葡萄糖注射液稀释,于0,2,4,6,8和24 h检测配伍后溶液的性状、pH、有关物质、不溶性微粒、可见异物及含量;奥扎格雷氨丁三醇注射用浓溶液分别经低温(2~8℃)和冻融(-10~-20℃)各3个循环,考察性状、pH、有关物质、不溶性微粒、可见异物及含量的变化。结果 奥扎格雷氨丁三醇注射用浓溶液分别用0.9%氯化钠注射液与5%葡萄糖注射液稀释后,24 h内各项检测指标均符合规定,且与0时相比无明显变化;奥扎格雷氨丁三醇注射用浓溶液经历低温、冻融各3个循环,各检测指标也均符合规定,且与0时相比无明显变化。结论 奥扎格雷氨丁三醇注射用浓溶液与0.9%氯化钠注射液、5%葡萄糖注射液在24 h内配伍稳定性良好;短期内经历低温或冷冻条件,不影响奥扎格雷氨丁三醇注射用浓溶液的质量。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 

分 类 号：R944.1[医药卫生—药剂学]