乳-N-四糖用于婴儿奶粉的安全性评估
- ①乳-N-四糖（LNT）是母乳中含量最丰富的乳寡糖之一，平均浓度约1.2 g/L；
- ②对微生物发酵所得的LNT（与母乳中LNT的结构相同）用于婴儿奶粉的安全性，进行临床前评估；
- ③在多项体外测试中，未检测到LNT具有基因毒性；
- ④对新生大鼠进行不同剂量的亚慢性口服灌胃毒性研究，最高剂量的LNT（4000 mg/kg体重/天）持续灌胃90天，未引起不良反应；
- ⑤这些结果支持LNT用于婴儿配方奶粉和作为食物成分的安全性（不超过母乳中的含量）。
- 人乳寡糖对婴儿的健康和发育有很多好处，乳-N-四糖（LNT）是母乳中含量最丰富的人乳寡糖之一，已能通过微生物发酵大规模生产。Regulatory Toxicology and Pharmacology近期发表研究，对LNT的食用安全性进行临床前评估，结果支持LNT用于婴儿奶粉和食品成分的安全性。
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Preclinical safety evaluation of the human-identical milk oligosaccharide lacto-N-tetraose
与人乳寡糖相同的乳-N-四糖的临床前安全性评估
Lacto-N-tetraose (LNT) is one of the most abundant oligosaccharides that are endogenously present in human breast milk. To simulate the composition of human breast milk more closely, commercial infant formula can be supplemented with human-identical milk oligosaccharides, which are manufactured structurally identical versions of their naturally occurring counterparts. As part of the safety evaluation of LNT, in vitro genotoxicity tests and a subchronic oral gavage toxicity study (in neonatal Sprague-Dawley rats) were conducted. In the subchronic study, LNT was administered at dose levels of 0, 1,000, 2500 or 4000 mg/kg body weight (bw)/day, once daily for at least 90 days, followed by a 4-week treatment-free period. An identically comprised reference control group received fructooligosaccharides powder (a non-digestible oligosaccharide used in infant formula) at 4000 mg/kg bw/day, to allow for direct comparison against the high-dose LNT group. LNT was non-genotoxic in the in vitro tests. There were no compound-related adverse effects in the 90-day study; therefore, 4000 mg/kg bw/day (the highest feasible dose) was established as the no-observed-adverse-effect-level. These results support the safe use of LNT in infant formula and as a food ingredient, at levels not exceeding those found naturally in human breast milk.
