过氧化氢酶-2能力验证样品的制备及其均一性和稳定性测定

Study on Preparation of Catalase-2 Samples Used for Proficiency Testing and Measurement for the Stability and Uniformity

目的制备a、b两个型别的过氧化氢酶-2能力验证样品,并对其均匀性和稳定性进行测定评价。方法均匀性测定均按照4%比例随机抽样,冻融稳定性以4次冻融为测定终点;时间-温度稳定性以4、20、37℃这3个温度为观测纵坐标,1、2、3、7、15、30 d为观测横坐标,在每个坐标交点,a型、b型分别随机抽取2瓶,测定不同条件下各型别样品的稳定性。结果a型、b型样品在均匀性测定中,均表现为各型别的清晰条带;4次冻融后仍能稳定存在,且30 d内在4、20℃和37℃三种条件下均能稳定存在。结论过氧化氢酶-2样品均匀性和稳定性良好,适于能力验证样品的制备发放需求。

Objective To prepare and evaluate catalase-2 sample(a type,b type)with good stability and uniformity.Method Extracting 4%samples randomly to finish the uniformity test.Samples were also extracted in the freeze thawing stability test for at most 4 times.As for the time-temperature uniformity,we used time(day)and temperature(℃)as the coordinate value:1,2,3,7,15,30 days were used as time coordinate,and 4,20,37℃as temperature coordinate;and 2 bottles of each type samples were observed at every fixed point.Result A type and b type clearly performed a and b band on their own.,and all of them were able to be stable after 4-time freeze thawing.And also the time-temperature stability test showed that standard samples of a type and b type could be present stable for 30 days at 4,20℃and 37℃.Conclusion Catalase-2 samples behaved well in the uniformity and stability test,which were up for the requirements of proficiency testing.