长春西汀注射剂溶血与凝聚试验的探讨

Investigation on hemolysis and coagulation test of vinpocetine injection

目的:对长春西汀注射剂的溶血性进行探索性研究。方法:参照《中国药典》2020年版四部通则溶血与凝聚检查法及原国家食品药品监督管理总局《药物刺激性、过敏性和溶血性研究技术指导原则》(2014)中的溶血方法进行试验。比较肉眼观察法和分光光度法对结果判断的差异性。结果:肉眼观察法存在漏判现象,采用分光光度法能消除肉眼观察法带来的主观误差,且敏感度优于肉眼观察法。结论:建议在长春西汀注射剂现行标准中增加溶血与凝聚检查项目,在肉眼观察溶血不明显或结论不确定时建议采用分光光度法进行结果判断。

Objective:To explore the hemolysis of vinpocetine injection.Method:The hemolysis and coagulation test was conducted by referring to the methods in Chinese Pharmacopoeia 2020 Vol IV and in the guidelines for the study of irritation,allergic and hemolysis of drug issued by State Food and Drug Administration in 2014.The differences on results judgement between visual observation and spectrophotometry were compared.Results:Visual observation method had the lost judgement.Spectrophotometry method could eliminate the subjective error caused by visual observation,and had higher sensitivity than that of visual observation.Conclusion:It is suggested to add hemolysis and coagulation test into the specification of vinpocetine injection and to use spectrophotometry method when the result obtained with visual observation is not obvious or the conclusion is not uncertain.