IMMUNOBIOTECH Corp. · 韩国nF1 热处理植物乳植杆菌nF1 heat-treated Lactiplantibacillus plantarum
从韩国泡菜分离的植物乳植杆菌，经热处理灭活并超微粒化，每克约 5 万亿个菌体，不需要冷链。
A Lactiplantibacillus plantarum strain isolated from kimchi, heat-inactivated and micronised: about 5 trillion cells per gram, with no cold chain required.
热处理灭活、超微粒化的植物乳植杆菌菌体粉（后生元）Heat-inactivated, micronised Lactiplantibacillus plantarum cell powder (postbiotic)
- 菌种 Species
- 植物乳植杆菌 Lactiplantibacillus plantarum（原名植物乳杆菌）
- 菌株 Strain
- nF1，分离自韩国泡菜
- 状态 State
- 热处理灭活，非活菌；冻干粉
- 菌体数 Cell count
- 约 5 × 1012 个/g（供应商规格）
- 粒径 Particle size
- 0.5–1.0 μm（美国专利 US 9,763,988 B2 所载）
- 组成 Composition
- nF1 菌体，不含载体与添加物（供应商声明）
- 耐热 Heat tolerance
- 150 °C、10 分钟后 IL-12 诱导活性为未处理样的 93%（供应商体外检测）
- 法规身份 Status
- 植物乳植杆菌列入中国《可用于食品的菌种名单》；未列入婴幼儿食品菌种名单
后生元 · 非活菌常温储运中 · 美 · 欧 · 韩 · 印核心专利人体随机对照试验
它是什么What it is
nF1 是一株从韩国泡菜中分离的植物乳植杆菌。它经过培养、热处理灭活、收集菌体、冻干和超微粒化，制成几乎只含菌体的粉末。和活菌益生菌不同，它不需要在货架期和消化道中存活，所以不怕加热、酸和常温储存，也不存在菌数衰减。按国际益生菌与益生元科学协会（ISAPP）2021 年的定义，这类「对宿主有益的灭活微生物及其成分」属于后生元（postbiotic）。它的作用基础是菌体结构本身，尤其是细胞壁上的肽聚糖、磷壁酸和多糖，这些成分可被免疫细胞表面的模式识别受体识别。
nF1 is a Lactiplantibacillus plantarum strain isolated from Korean kimchi. It is cultured, heat-inactivated, harvested, freeze-dried and micronised into a powder made almost entirely of cells. Unlike live probiotics, it does not need to survive shelf life or digestion, so it tolerates heat, acid and ambient storage, and its cell count does not decline. Under the 2021 ISAPP definition, such "inactivated microorganisms and/or their components that confer a health benefit" are postbiotics. Its basis is the cell structure itself, especially cell-wall peptidoglycan, teichoic acids and polysaccharides, which immune cells recognise through pattern-recognition receptors.
- 泡菜中分离菌株Strain isolated from kimchi
- 种子与发酵培养Seed and fermentation culture
- 热处理灭活Heat inactivation
- 离心收集菌体Cells harvested by centrifugation
- 冻干Freeze-drying
- 超微粒化，0.5–1.0 μmMicronisation to 0.5–1.0 μm
- 检测 · 包装Testing · packing
组成与规格Composition & specification
供应商规格：灭活菌体约 5 × 1012 个/g，不含载体。美国专利所载粒径分布为 0.5–1.0 μm，属亚微米级。供应商体外检测（小鼠细胞，菌体 10 μg/mL，以溶链菌制剂 OK-432 为阳性对照）报告：未处理样 IL-12 为 338 pg/mL；再经 120、140、150 °C 各 10 分钟处理后分别为 291、277、315 pg/mL，160 °C 时降至 164 pg/mL；经模拟胃酸、胰酶处理后为 420 pg/mL，加胆汁后为 405 pg/mL。这组数据说明常规杀菌、烘焙和挤压工艺不必为它单独调整，但属企业内部检测，报告未给出统计检验结果。
Supplier specification: about 5 × 1012 inactivated cells per gram, with no carrier. The US patent gives a particle-size distribution of 0.5–1.0 μm, i.e. sub-micron. A supplier in-vitro assay (mouse cells, 10 μg/mL of cells, with the streptococcal preparation OK-432 as positive control) reported IL-12 of 338 pg/mL for untreated material; 291, 277 and 315 pg/mL after a further 10 minutes at 120, 140 and 150 °C; 164 pg/mL at 160 °C; and 420 pg/mL after simulated gastric acid and pancreatin, or 405 pg/mL with bile added. This suggests routine sterilisation, baking and extrusion need not be adapted for it, but it is internal company data and the report gives no statistical tests.
研究方向：免疫指标与肠道健康Research area: immune markers and gut health
以下为已发表人体研究的设计与观察结果摘录，供研发与法规评估参考；不构成对原料或终端产品的功能宣称。2017 年研究的作者包括酸奶生产企业人员，2024 年研究的作者包括原料企业人员。
Design and reported observations of published human studies, provided for R&D and regulatory review only. Not a functional claim for the ingredient or any finished product. Authors of the 2017 study include staff of the yogurt manufacturer; authors of the 2024 study include staff of the ingredient company.
- 2017
随机、开放标签、对照试验，200 名成人，12 周；酸奶含副干酪乳杆菌、动物双歧杆菌乳亚种（活菌）和热处理植物乳杆菌三种菌，对照组饮用牛奶
Randomised, open-label, controlled trial, 200 adults, 12 weeks; yogurt with L. paracasei, B. animalis ssp. lactis (live) and heat-treated L. plantarum, versus milk
试验组 NK 细胞活性、IFN-γ 和 IgG1 的升幅显著大于对照组。结果来自三菌组合，不能单独归因于 nF1。（Lee 等，Nutrients 2017; 9(6): 558）
NK-cell activity, IFN-γ and IgG1 rose significantly more than in the milk group. The result reflects the three-strain combination and cannot be attributed to nF1 alone. (Lee et al., Nutrients 2017; 9(6): 558)
- 2020
中国研究，90 名健康成人，14 天；灭菌型乳酸菌饮料分别添加聚葡萄糖或 nF1
Chinese study, 90 healthy adults, 14 days; sterilised lactic-acid-bacteria drinks with added polydextrose or nF1
聚葡萄糖组排便次数、大便颜色、形状、硬度等多项改善；nF1 组仅大便颜色一项达显著。作者认为聚葡萄糖作用更明显。（王晓等，食品与营养科学 2020; 9(1): 38–46）
The polydextrose group improved on stool frequency, colour, form, hardness and more; the nF1 group improved significantly on stool colour only. The authors judged polydextrose more effective. (Wang et al., Hans J Food Nutr Sci 2020; 9(1): 38–46)
- 2022
随机、双盲、对照试验，90 名肠易激综合征患者分三组，每天 210 g 泡菜，12 周：普通泡菜、添加 nF1 的泡菜、功能性泡菜
Randomised, double-blind, controlled trial, 90 people with IBS in three groups, 210 g kimchi daily for 12 weeks: standard, nF1-added, or functional kimchi
三组的典型症状、排便时间和大便形态均有改善，血清 TNF-α 均下降。作者单独归于 nF1 的是免疫相关指标的改善。（Kim 等，Food Nutr Res 2022; 66: 8268）
All three groups improved on typical symptoms, defecation time and stool form, and serum TNF-α fell in all groups. The authors attributed improvement in immune-related markers specifically to nF1. (Kim et al., Food Nutr Res 2022; 66: 8268)
- 2024
随机、双盲、安慰剂对照试验，100 名白细胞计数正常的成人，每天 5 × 1011 个菌体（约 0.1 g），8 周
Randomised, double-blind, placebo-controlled trial, 100 adults with normal white-cell counts, 5 × 1011 cells daily (about 0.1 g), 8 weeks
nF1 组 IL-12 变化达显著（p = 0.045）；在基线分泌型 IgA 与 NK 活性偏低的亚组中，NK 细胞活性变化显著增加；未报告安全性问题。（Hong 等，Nutrients 2024; 16(9): 1339）
IL-12 changed significantly in the nF1 group (p = 0.045); in the subgroup with low baseline secretory IgA and NK activity, the change in NK-cell activity increased significantly; no safety issues were reported. (Hong et al., Nutrients 2024; 16(9): 1339)
安全性数据Safety data
灭活菌体不会在体内定植或增殖。成人 8 周、每天 5 × 1011 个菌体的随机对照试验未报告安全性问题；另一项研究中，2 月龄以下健康婴儿连续 8 周摄入也未报告安全问题（Kwon 等，J Nutr Metab 2024）。但 nF1 未列入中国《可用于婴幼儿食品的菌种名单》，在中国不能用于婴幼儿食品。毒理学资料、过敏原声明与批次检测以供应商文件为准。
Inactivated cells do not colonise or multiply in the body. An eight-week randomised trial in adults at 5 × 1011 cells daily reported no safety issues, and a study in healthy infants under two months old taking it for eight weeks also reported none (Kwon et al., J Nutr Metab 2024). nF1 is not on China's list of strains permitted in infant foods, however, so it cannot be used in infant foods in China. Toxicology, allergen statements and batch testing follow the supplier's documents.
应用Applications
粉剂、片剂、胶囊、口腔崩解膜、常温饮料、酸奶与乳饮料、烘焙和膨化食品、化妆品。人体试验用量为每天 5 × 1011 个菌体，按规格约 0.1 g；作复配辅料时供应商常用 5 × 1010–1 × 1011 个。无色无味，用量极小，基本不影响口感和剂型体积；耐高温杀菌，不需要肠溶包衣或微囊化。在中国作普通食品原料不得宣称功能；益生菌类保健食品的审评要求以活菌计，灭活菌需按保健食品注册路径另行评估。
Powders, tablets, capsules, orally dissolving films, ambient drinks, yogurt and dairy drinks, baked and extruded foods, and cosmetics. The human trial used 5 × 1011 cells a day, about 0.1 g at specification; as a supporting ingredient the supplier commonly uses 5 × 1010 to 1 × 1011 cells. It is colourless and tasteless and used in tiny amounts, so it barely affects taste or dose size; it withstands high-temperature sterilisation and needs no enteric coating or microencapsulation. In China it can be used in ordinary foods without function claims; probiotic health-food rules are based on live counts, so an inactivated strain must be assessed separately under health-food registration.
专利与商标Patents & trademarks
- ZL 2013 8 0072367.8具有诱导 IL-12 产生的能力的乳酸杆菌及其培养方法中国发明专利，2021 年授权，申请日 2013-07-22；专利权人：韩国生命源株式会社等
- US 9,763,988 B2Nano-sized kimchi lactic acid bacteria（nF1，粒径 0.5–1.0 μm）美国，2017 年授权；专利权人：Biogenics Korea Co., Ltd.
- KR 10-1583018 · EP 2930235 B1 · IN 352499IL-12 诱导乳酸菌及其制法，同族专利韩国、欧洲、印度
- KR 10-1638984 等纳米型泡菜乳酸菌及食品、饮料、化妆品应用专利韩国
资料Documents
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本页信息来自供应商文件与公开发表的研究，供研发与法规评估参考，不代表原料或终端产品在中国可直接宣称相应功能。
Information on this page comes from supplier documents and published research and is provided for R&D and regulatory review. It does not constitute or permit any health-function claim for the ingredient or finished products sold within China.