凝血酶溶液冷藏保存对蚓激酶效价测定稳定性的影响

目的 初步考察分析凝血酶溶液冷藏保存对蚓激酶效价测定稳定性的影响。方法 采用冰箱冷藏方法 对凝血酶溶液进行保存，定期取出用于蚓激酶效价测定，统计分析其对蚓激酶效价测定的影响，并采用药物分析验证方法 对冷藏25d的凝血酶溶液用于蚓激酶效价测定进行相关方法 学验证。结果 凝血酶溶液冷藏0～25d，用于配制琼脂糖纤维蛋白平板，对测定蚓激酶效价无明显影响；凝血酶溶液冷藏至30d后，用于测定的蚓激酶效价偏低，且其标准曲线线性关系也较差，存在较明显影响；冷藏25d的凝血酶溶液用于效价测定方法 学验证，精密度、准确度和线性关系良好。结论 凝血酶溶液冷藏0～25d较为适宜，所配制琼脂糖纤维蛋白平板不影响蚓激酶效价的测定与判断。

Effects of thrombin solution refrigerated on stability of the lumbrokinase titer test

Objective To investigate stability of the lumbrokinase titer test of thrombin solution refrigerated. Methods Thrombin solution was preserved through the refrigerator, then the lumbrokinase titer were determined in regular time, effects were analyzed that thrombin solution refrigerated on stability of the lumbrokinase titer test. The method of lumbrokinase titer test was verified through drug analysis using thrombin solution for refrigerated 25 days. Results There was no significant effect on the lumbrokinase titer determination when the thrombin solution refrigerated 0-25 days for the preparation of agarose fibrin plate. There was obviously effect when thrombin solution chilled to 30 days, and lumbrokinase titer was low, and the linear relationship of the standard curve was also poor. There was good precision, accuracy and linearity when thrombin solution for refrigerated the 25 day titer determination method was used method validation. Conclusion The thrombin solution that refrigerate 0-25 days is more appropriate, The agarose fibrin plate that use refrigerating thrombin solution dose not affect the determination and judgment of lumbrokinase potency.