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作 者:彭飞城 王蓉蓉 PENG Fei-cheng;WANG Rong-rong(Hunan Institute for Drug Control,Changsha 410001,China)
机构地区:[1]湖南省药品检验研究院
出 处:《海峡药学》2019年第6期15-16,共2页Strait Pharmaceutical Journal
基 金:“重大新药创制”国家科技重大专项(2012ZX09301002-001-019);2015年国家药品抽验计划
摘 要:目的研究门冬氨酸钾镁注射液体外溶血反应。方法将5家不同厂家生产的10批门冬氨酸钾镁注射液分别从原液检测起,按1∶2倍逐步稀释至临床最大使用量相对应的稀释倍数(1∶12.5倍),分别通过两种方法:常规肉眼观察法、分光光度法检测其对新鲜兔血的溶血性。结果两种方法测得结果基本一致,各厂家的门冬氨酸钾镁注射液从原液起均无溶血现象。结论门冬氨酸钾镁注射液在临床使用剂量时无体外溶血反应;建议紫外分光光度法作为溶血反应的仲裁方法。OBJECTIVE To study the effect of potassium aspartate and magnes ium aspartate injection on hemolytic degree. METHODS The test s olutions were prepared by diluting potassium aspartate and magnesium aspartate i njection from original to clinical use.The hemolytic degree of rabbit erythrocy tes caused by the test solutions was measured by routine macroscopy and spectrom etry. RESULTS Both methods proved that potassium aspartate and m agnesium aspartate injection had no hemolytic reaction from original solution. CONCLUSION Potassium aspartate and magnesium aspartate injectio n is safe for clinical use without hemolytic reaction.Spectrometry is suggested as arbitration method during hemolytic reaction.
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