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目的:建立肝素结合力-滴定法,测定硫酸鱼精蛋白生物活性,用于替代现行药典标准的兔全血法测定方法。方法:分析国内外硫酸鱼精蛋白生物活性测定法的研究进展,在本试验室开展肝素结合力-滴定法测定生物活性研究,通过方法学研究,并与兔全血法进行一致性考察,确定该方法在本实验室开展的可行性。结果:本试验室建立了肝素结合力-滴定法测定硫酸鱼精蛋白生物活性的方法,该方法重复性和中间精密良好,并与兔全血法测定结果具有较好的一致性。结论:肝素结合力-滴定法测定硫酸鱼精蛋白生物活性,采用仪器测定,避免人为判定终点造成的误差,方法操作简单,客观性更强,测定结果更准确,测定效率更高,并与兔全血法测定结果一致性良好,可作为兔全血法的替代方法。
OBJECTIVE: To establish a heparin binding-titration method for the determination of protamine sulfate bioactivity and to replace the current standard method for the determination of rabbit whole blood. Methods: The research progress in the determination of protamine sulphate in vitro and in vivo was studied. The heparin binding force-titration assay was used to determine the bioactivity in this laboratory. The feasibility of this method in our laboratory. Results: The method of heparin binding-titration was used to determine the bioactivity of protamine sulfate. The method was reproducible and accurate in the middle, and was in good agreement with the results of rabbit whole blood assay. Conclusion: Heparin binding force - titration method for the determination of protamine sulfate bioactivity, the determination of the instrument to avoid the error caused by artificial end-point determination, the method is simple, more objective, the determination results are more accurate, higher determination efficiency, and with rabbit The results of the whole blood test results are consistent and can be used as an alternative to the rabbit whole blood test.