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目的测定人乳铁蛋白转基因山羊奶及非转基因山羊奶中乳糖的含量,考察两者是否存在显著性差异,为人乳铁蛋白转基因山羊奶的实质等同性评价提供依据。方法采用APS-2 HYPERSIL色谱柱,以乙腈-水(7︰3)为流动相,示差折光检测器,测定两种山羊泌乳30 d、60 d及90 d采集的羊奶中各90个样本的乳糖含量,用SPSS软件对测定结果进行统计学处理。结果泌乳30 d、60 d及90 d采集的样本中,转基因山羊奶的平均乳糖含量分别为43.2 mg/ml、37.4 mg/ml及40.2 mg/ml;非转基因山羊奶的平均乳糖含量分别为38.2 mg/ml、31.7 mg/ml及37.2 mg/ml。结论在3个时间段采集的样本中,转基因与非转基因山羊奶中的乳糖含量均不存在显著性差异(P≥0.05)。
Objective To determine the content of lactose in human lactoferrin transgenic goat milk and non-transgenic goat milk, and to find out whether there is a significant difference between them, and to provide the basis for the substantial equivalence evaluation of human lactoferrin transgenic goat milk. Methods The APS-2 HYPERSIL column was used with mobile phase of acetonitrile-water (7︰3) as the mobile phase and refractive index detector to measure 90 samples of goat’s milk collected on the 30th, 60th and 90th days after lactation Lactose content, using SPSS software for statistical analysis of the measurement results. Results The average lactose content of transgenic goat’s milk was 43.2 mg / ml, 37.4 mg / ml and 40.2 mg / ml respectively at 30 d, 60 d and 90 d after lactation. The average lactose content of non-transgenic goat’s milk was 38.2 mg / ml, 31.7 mg / ml and 37.2 mg / ml. Conclusion There was no significant difference in lactose content in transgenic and non-transgenic goat milk samples collected in three time periods (P> 0.05).