Comparison and analysis of two potency assay methods of protamine sulfate

VernacularTitle:两种硫酸鱼精蛋白效价测定方法的比较与分析
Author: Ping LIU ; Jianqin GU ; Jie SUN ; Yue HU ; Zhuhui JIANG ; Zhaocheng ZHENG ; Liming TANG
Publication Type:Journal Article
Keywords: protamine sulfate; biological assay; heparin titration method
From: Chinese Journal of Biochemical Pharmaceutics 2016;36(8):145-148
CountryChina
Language:Chinese
Abstract: 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.