溶血率测定法在鱼腥草注射液安全性再评价中的应用

Application of the Mensuration of Hemolysis Ratio to the Safety Re-evaluation of Yuxingcao Injection

目的研究溶血率测定法在鱼腥草注射液再评价中的应用,为提高鱼腥草注射液质量标准提供参考。方法参照药品包装材料国家标准中的溶血率测定方法,对5家厂家生产的9批样品进行溶血率测定,并进行比较。结果结果2批样品的溶血率分别为73%和75%,一批样品的溶血率为5%,其余6批样品的溶血率均小于5%,重现性良好。结论溶血率测定方法可用于鱼腥草注射液的质量控制。

OBJECTIVE To study the application of the mensuration of hemolysis ratio to its safety re-evaluation in order to elevate the quality standard of yuxingcao injection. METHODS The hemolysis ratios of 9 batches of samples taken from 5 different factories according to the state drug and packed material standard were measured and compared. RESULTS The hemolysis ratios obtained from the study are as follows： three samples are 73% ,75% ,and 5% ,the remains are less than 5%. CONCLUSION The mensuration of hemolysis ratio can be used for the quality control of yuxingcao injection.