硫酸鱼精蛋白生物测定标准研究

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: The establishment of heparin binding-titration method to determine the biological activity of protamine sulfate,and to determine the method of the rabbit blood test by replacing the current Pharmacopoeia standard.Methods: The domestic and overseas research progress of the determination of the bioactivity of protamine sulfate was studied,and to bioactivity of heparin binding-titration method was studied in this laboratory. Through a methodological study, together with a comformance inve stigation with rabbit blood method,the feasibility of this methed in the lab is determined.Results: The method of biological activity of protamine sulfate was established by heparin binding-titration in our lab, the repeatability and precision of the method was good, and the results were consistent with those in the rabbit whole blood method.Conclusion: the determination of biological activity of protamine sulfate titration of heparin binding force by using instrument measurement to avoid errors caused by man-made judgment is simple,more objective and more accurate,and its efficiency is higher,and the results were in good agreement with the rabbit whole blood method. The method be used as an alternative method of abbit whole blood.

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