论文部分内容阅读
目的：分析并比较两种硫酸鱼精蛋白的效价测定方法。方法分别采用肝素-结合力滴定法和生物测定法对5批硫酸鱼精蛋白进行效价测定，滴定法依据国外药典，生物测定法依据《中国药典》施行。结果肝素结合力-滴定法的滴定终点吸光度值在中（0.10 mg／mL）、高浓度（0.15 mg／mL）相对稳定，效价数据的相对标准偏差（RSD）小于5％。三种待测液浓度与肝素标准品滴加量呈良好的线性关系，相关系数R2为1.000。将滴定法与生物测定法效价结果进行比较，两种方法的相关性显著（ P＝0.013），误差水平一致（P＞0.05），但滴定法测得的效价数值略低于生物测定法结果（P＝0.045）。结论肝素结合力-滴定法的方法可行、操作简便，国内应积极推广。“,”Objective To analyze and compare two potency assay methods of protamine sulfate.Methods Heparin titration method was according to foreign pharmacopoeia,while biological assay method was according to China pharmacopoeia(2015).Results The absorbance at the end-point was stable at 0.10 mg/mL and 0.15 mg/mL test solutions.The relative standard deviations(RSDs)of potency results were all less than 5%.Three test solutions and volumes of the titrant had a good linear relationship(R2 =1.000).The results of titration method were significantly related to those of biological assay(P=0.013),with similar RSD(P>0.05).However,the potency of titration method were significantly lower than those of biological assay (P=0.045).Conclusion Heparin titration method is good-using,convenient,and need to be applied widely at home.