摘要
目的:制备均匀性和稳定性良好的能力验证用酯酶-3样品(a型、c型、ac型),为标准样品的制备、保存和发放等提供基础科研数据。方法:均匀性实验按照随机原则抽取4%比例的样品进行测定。稳定性实验以4℃、室温(RT)和37℃这3个温度为观测纵坐标,1、4、7、14、30、60、90 d为观测横坐标,在每个坐标交点,a型、c型及ac型样品分别随机抽取2瓶,测定各型别样品在不同条件下的稳定性。结果:在均匀性测定实验中,a型、c型及ac型均表现为各自型别的清晰条带。经稳定性实验测定表明,在4℃条件下,a型、c型和ac型标准样品分别可以稳定存放60、90、30 d;在室温条件下,a型、c型和ac型标准样品分别可以稳定存放7、30、7 d;在37℃条件下,所有样品均可稳定存放1 d。结论:酯酶-3标准样品均匀性良好,符合能力验证标准样品制备、发放和实验的要求;标准样品的稳定性对温度变化比较敏感,应避开高温天气运输或采用冷链运输。
Objective： To prepare esterase-3 standard samples（type a, type c, and type ac） with good stability and uniformity, which could be used for laboratory proficiency testing, and to provide scientific data for the distribution, preparation, and storage of standard samples. Methods： The 4% of samples were randomly selected for the uniformity test. 2 bottles of each type of samples were selected at each intersection point of the coordinates to test stability with 1 day, 4 days, 7 days, 14 days, 30 days, 60 days, 90 days as time coordinate, and 4 ~C, room temperature （RT）, 37 ~C as temperature coordinate. Results： In the uniformity test, samples of type a, type c, and type ac showed clear bars respectively. The stability test showed that the standard samples of type a, type c, and type ac were stable for 60 days, 90 days and 30 days at 4 ~C respectively, and for 7 days, 30 days and 7 days at room temperate, and for 1 day at 37 ~C. Conclusion： All the type a, type c, and type ac standard samples behave well in the uniformity test, which meets the requirements of proficiency testing for preparation, distribution and experiment. The stability of the standard samples is sensitive to the temperature variation, therefore, the hot weather should be avoided for sample transportation and cold-chain transportation should be adopted.
出处
《中国药事》
CAS
2015年第3期277-280,共4页
Chinese Pharmaceutical Affairs
基金
国家科技支撑计划(编号2013BAK11B01
2013BAK11B03)
关键词
实验室质量管理
能力验证
酯酶-3标准样品
均匀性试验
稳定性试验
laboratory quality management
proficiency testing
esterase-3 standard sample
uniformity test
stability test
