摘要
目的:对市场上流通的醒脑静注射液在溶血性方面进行考察研究。方法:参考《中国药典》2015年版四部生物检查法及注射剂安全性检查法应用指导原则和中药、天然药物刺激性和溶血性研究的技术指导原则,对市售所有厂家的34批醒脑静注射液分别制备成3个浓度进行溶血试验研究,并采用肉眼观察法和分光光度法判定溶血结果,比较两种方法的差异性。结果:相同厂家不同批次、不同厂家间醒脑静注射液的溶血率存在差异,另外,在溶血率为5%~15%时,肉眼观察法存在漏判现象。结论:在临床使用和实验室监测中应该高度重视醒脑静注射液溶血的不良反应,建议在其现行标准中增加“溶血与凝聚”安全性检查项目,并采用分光光度法测定溶血率。
Objective To investigate the hemolysis of Xingnaojing injection in circulation. Methods Referring to the guiding principles for the application of biological test and safety test of traditional Chinese medicine injections in four parts of Chinese Pharmacopoeia(2015 edition) and the technical guidelines for the study of irritation and hemolysis of traditional Chinese medicine and natural medicine, 34 batches of Xingnaojing injection from all manufacturers were prepared into three concentrations for hemolysis test, and the hemolysis was determined by eye observation and spectrophotometry. Result The hemolysis rate of Xingnaojing injection from the same manufacturer was different in different batches and manufacturers. In addition, when the hemolysis rate was 5%~15%, the naked eye observation method had the phenomenon of missed judgement. Conclusion In clinical use and laboratory monitoring, great attention should be paid to the adverse reactions of hemolysis of Xingnaojing injection. It is suggested that the safety test items of "hemolysis and coagulation" should be added to its current standard, and the hemolysis rate should be determined by spectrophotometry.
作者
刘勤
王璐
张红宇
LIU Qin;WANG Lu;ZHANG Hongyu(YunNan Istitute for Food and Drug Control,Kunming 650000,China)
出处
《中国民族民间医药》
2019年第14期13-16,共4页
Chinese Journal of Ethnomedicine and Ethnopharmacy
