不同因素对苹果酸酶-1和异柠檬酸脱氢酶-1标准样品的影响分析  

Study on Different Influence Factors in Malic Enzyme-1 and Isocitrate Dehydorgenase-1 Standard Samples

作　　者：魏杰[1] 王洪[1] 光姣娜 周佳琪 付瑞[1] 岳秉飞[1] WEI Jie;WANG Hong;GUANG Jiaona;ZHOU Jiaqi;FU Rui;YUE Bingfei(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《实验动物科学》2022年第3期40-44,共5页Laboratory Animal Science

基　　金：国家科技重大专项“艾滋病和毒性肝炎等重大传染病防治专项”(2017ZX10304402)。

摘　　要：目的分析温度-时间、浓度、冻融、运输条件和不同品系来源对苹果酸酶-1(malic enzyme-1,ME-1)和异柠檬酸脱氢酶-1(isocitrate dehydorgenase-1,IDH-1)标准样品的影响。方法制备C57BL/6、BALB/c和CBA三种近交系小鼠来源的标准样品,经均匀性测定后,随机抽样按照GB/T 14927.1—2008中的检测方法进行测试。温度-时间因素以4℃、室温(RT)和37℃这3个温度为观测纵坐标,1、2、3、7、14和21 d为观测纵坐标。在每个坐标交点,每品系分别随机抽取两管。浓度因素按照每品系一管进行原倍、1/2、1/4和1/8倍进行梯度测试。冻融因素,每品系3管,-20℃冻存2 h至室温融化3次为条件测试。所有实验均为相同的运输条件、干冰冷链及北京往返沈阳、西安、成都三地测试。结果不同品系来源标准样品在温度-时间、浓度、冻融和运输条件下无显著差异。各标准样品21 d内在4℃及室温(RT)条件下,均能稳定存在,但37℃仅能稳定存在2 d。原倍稀释至1/8浓度、3次冻融和干冰运输三地往返后,样品检测结果显示稳定。结论制备的ME-1和IDH-1标准样品具备均一性、稳定性和可比性,满足能力验证计划需求。Objective To analyze the influencing factors of temperature-time,concentration,freeze thawing,transportation conditions and different strain sources in malic enzyme-1 and isocitrate dehydorgenase-1 standard samples.Method C57BL/6,BALB/c and CBA inbred mice were used to prepare standard samples.After homogeneity test,random samples were collected and tested according to GB/T 14927.1—2008.We used 4℃,room temperature(RT)and 37℃as horizontal ordinate,and day 1,day 2,day 3,day 7,day 14 and day 21 as ordinate to analyze temperature-time factors.At each coordinate point,two tubes are randomly selected from each strain.The concentration factors were measured by the gradient of original,1/2,1/4 and 1/8 concentration samples in 1 tube per strain.In the factors of freeze thawing analysis,we tested samples(3 tubes per strain)for 3 times under the conditions of 2 hour storage at-20℃and thawing at room temperature.The transportation condition were 3 round-trip test from Beijing to Shenyang,Xi’an and Chengdu using dry ice in cold chain.Result There were no significant differences in temperature-time,concentration,freeze-thaw and transportation conditions among the standard samples from different strains.Each standard sample could exist stably in condition of 4℃,RT for 21 days,and only 2 days at 37℃.After dilution to 1/8 concentration,3 times freeze-thaw and dry ice transportation,the samples can still be stable.Conclusion The malic enzyme-1 and isocitrate dehydorgenase-1 standard samples are homogeneous,stable and comparable,whIch can meet the requirements of the proficiency testing program.

关 键 词：苹果酸酶-1 异柠檬酸脱氢酶-1 均匀性 稳定性 影响因素 

分 类 号：Q95-3[生物学—动物学]