Abstract: 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.

Key words: Catalase-2, sample, proficiency testing, uniformity, stability

摘要： 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。

关键词: 过氧化氢酶-2, 样品, 能力验证, 均匀性, 稳定性