复方麝香注射液体外溶血反应研究  

Study on hemolytic reaction of Fufang Shexiang injection in vitro

作　　者：朱勤[1] 许雷鸣[1] 

机构地区：[1]安徽省食品药品检验所,安徽合肥230051

出　　处：《安徽医药》2013年第10期1672-1673,共2页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省食品药品监管系统科研项目(No 0004)

摘　　要：目的根据国家药典委员会对于中药注射剂质量标准提高工作的要求,研究复方麝香注射液体外溶血反应情况为其临床安全应用提供依据。方法将5家不同厂家生产的13批复方麝香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一致,各厂家的复方麝香注射液从1∶6倍浓度稀释液(未超过临床最大使用量)起均无溶血与凝聚现象。结论复方麝香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 Fufang Shexiang injection on hemolytic degree in order to provide evidence for its clinical safe use. Methods The test solutions were prepared by diluting Fufang Shexiang injection from original to clinical use, The hemolytic degree of rabbit erythrocytes caused by the test solutions was measured by routine macroscopy, spectrometry. Results Both methods prove that Fufang Shexiang injection have no hemolytic reaction from six times diluted solution. This diluted times solution is less than the clinical used solution. Conclusion Fufang Shexiang injection is safe for clinical use without hemolytic reaction. Spectrometry is sug gested as arbitration method during, hemolytic reaction.

关 键 词：复方麝香注射液 溶血反应 

分 类 号：R286.0[医药卫生—中药学]