乳-N-四糖用于嬰兒奶粉的安全性評(píng)估
- ①乳-N-四糖（LNT）是母乳中含量最豐富的乳寡糖之一，平均濃度約1.2 g/L；
- ②對(duì)微生物發(fā)酵所得的LNT（與母乳中LNT的結(jié)構(gòu)相同）用于嬰兒奶粉的安全性，進(jìn)行臨床前評(píng)估；
- ③在多項(xiàng)體外測(cè)試中，未檢測(cè)到LNT具有基因毒性；
- ④對(duì)新生大鼠進(jìn)行不同劑量的亞慢性口服灌胃毒性研究，最高劑量的LNT（4000 mg/kg體重/天）持續(xù)灌胃90天，未引起不良反應(yīng)；
- ⑤這些結(jié)果支持LNT用于嬰兒配方奶粉和作為食物成分的安全性（不超過(guò)母乳中的含量）。
- 人乳寡糖對(duì)嬰兒的健康和發(fā)育有很多好處，乳-N-四糖（LNT）是母乳中含量最豐富的人乳寡糖之一，已能通過(guò)微生物發(fā)酵大規(guī)模生產(chǎn)。Regulatory Toxicology and Pharmacology近期發(fā)表研究，對(duì)LNT的食用安全性進(jìn)行臨床前評(píng)估，結(jié)果支持LNT用于嬰兒奶粉和食品成分的安全性。
-
Preclinical safety evaluation of the human-identical milk oligosaccharide lacto-N-tetraose
與人乳寡糖相同的乳-N-四糖的臨床前安全性評(píng)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.
