肝素结合力法测定硫酸鱼精蛋白生物效价的可行性研究

目的：考察肝素结合力法是否可用于测定硫酸鱼精蛋白生物效价。方法：考察肝素结合力法测定硫酸鱼精蛋白生物效价的精密度、准确度、耐用性，以及肝素结合力法与血凝法的一致性。结果：肝素结合力法测定硫酸鱼精蛋白效价的精密度及准确度均较高：重复性为1.2%，中间精密度为1.8%，加样回收率为99.1%。2种方法测定的硫酸鱼精蛋白效价结果无显著性差异（p>0.05），且具有显著相关性（p<0.000 1）。结论：肝素结合力法可用于测定硫酸鱼精蛋白生物效价，与血凝法相比具有更强的客观性和简便性，更高的精密度和准确度，因此可以成为现有血凝法的替代方法。

Objective: To evaluate the feasibility of heparin-binding capacity method for testing biological potency of protamine sulfate. Methods: The precision, accuracy and robustness of heparin-binding method were determined. The consistency of coagulation method and heparin-binding capacity method by bivariate regression was analyzed. Results: Heparin-binding capacity method possesses better precision and accuracy than that of coagulation method for testing biological potency of protamine sulfate. The repeatability is 1.2%, intermediate precision is 1.8%, and recovery is 99.1%. No significant difference of protamine sulfate biological potency determined by heparin-binding capacity method and coagulation method was found. Conclusion: Heparin-binding capacity method can be used for measuring biological potency of protamine sulfate. Moreover, the method is more objective, simple, convenient, precise and accurate compared with coagulation method. It could be an alternative method to replacing the coagulation method.

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