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

Abstract: 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.

Key words: malic enzyme-1, isocitrate dehydorgenase-1, uniformity, stability, influence factors