원료 사전 탐색/lactobacillus-ferment-lysate/LACTOBACILLUS FERMENT LYSATE
Tier 2 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
발효·마이크로바이옴 (Ferment)

LACTOBACILLUS FERMENT LYSATE

식약처 한글 표준명: 락토바실러스발효용해물
피부컨디셔닝제
[식약처 공정서 기원 및 정의] 이 원료는 락토바실러스 발효물을 용해한 것이다.
[EU CosIng Official Definition] Lactobacillus Ferment Lysate is a lysate of the product obtained by fermentation of Lactobacillus.
결론 선행 Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

화장품에서 락토바실러스발효용해물 (LACTOBACILLUS FERMENT LYSATE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?

락토바실러스발효용해물(표준 INCI: LACTOBACILLUS FERMENT LYSATE, CAS 번호: N/A)은 화장품 처방에서 주로 피부컨디셔닝제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.1–5.0%(적정 pH 4.5–7.5) 범위에서 안정적으로 처방됩니다.

7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스

각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건
7-Track Official Statutory Label Names for LACTOBACILLUS FERMENT LYSATE
국가·규제 트랙공식 고시 전성분 표기명원클릭 복사
① 한국 (MFDS 화장품 한글 표준명)락토바실러스발효용해물
② 한국 구명칭 (개정 전 이력 · 301 리다이렉트)——
③ 유럽 (EU CosIng EC 1223/2009)LACTOBACILLUS FERMENT LYSATE
④ 미국 일반화장품 (US PCPC / MoCRA INCI)LACTOBACILLUS FERMENT LYSATE
⑤ 미국 OTC (FDA Active Ingredient Monograph)— (비-OTC 일반 화장품 원료)—
⑥ 중국 (NMPA IECIC 표준 중문명)乳酸杆菌发酵溶胞产物
⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW)LACTOBACILLUS FERMENT LYSATE (표준 INCI 기준 · 임의 가타카나 변환 배제)

Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태

Layer 1 Statutory Regulatory Limits Across 6 Regions for LACTOBACILLUS FERMENT LYSATE
권역규제 상태배합 한도제한 조건 및 1차 법원 출처
한국 (MFDS)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
유럽 (CosIng)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
미국 (FDA/CIR)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
중국 (NMPA)등재·허용GMPIECIC Entry #5676
일본 (MHLW)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
아세안 (ACD)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
⚠️ 참조용 안내 (법적 면책 공지): 이 사전의 성분명·규제 한도·배합 가이드는 연구·개발 참조용으로만 제공됩니다. 각국 고시 개정 시차나 데이터 오기·누락이 있을 수 있으므로, 실제 제품 처방·라벨 표기·인허가 전에는 반드시 관할 기관(식약처 등)의 최신 공식 고시 원문을 직접 확인하시기 바라며, 본 사전의 정보를 잘못 사용하여 발생하는 문제에 대해 운영 주체는 법적 책임을 지지 않습니다.
피부 투과 과학 시각화 (Bos & Meinardi 500 Dalton Rule)MW: Macro/Complex · LogP: N/A

각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션

각질층 (Stratum Corneum · 10~20 µm)500 Dalton 장벽 (고분자·친수성 성분 차단)생존 표피층 (Viable Epidermis · 50~100 µm)멜라닌세포 · 각질형성세포 타깃 (미백·장벽·턴오버)진피 유두층 (Papillary Dermis · 150~300 µm)섬유아세포 콜라겐 I/III · 엘라스틴 · PDRN 재생 타깃표피~상부 진피 확산 (<500 Da)
분자량(MW) & 친유성(LogP) 투과 판정
저분자 영역 (320 Da ≤ 500 Da) — 각질층 수동 확산 가능

단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.

예상 도달 깊이
40–90 µm
권장 전달 시스템
Polyol Enhancer / Serum
계면화학 · pH · 열역학 공정 시각화

pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동

적정 처방 pH 안전 윈도우 (pH 0 ~ 14 스펙트럼)pH 4.5 – 7.5
0245.5791114

권장 구간 밖(pH < 4.5 또는 pH > 7.5)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.

공정 가열 한계 온도 (Max Process Temp)≤ 70°C
25°C45°C60°C75°C85°C100°C

최대 70°C 가열 공정에서 열적 안정성이 유지됩니다.

계면활성·유화 HLB 스펙트럼 (0 ~ 20) & 미셀/액정 배열 시뮬레이터
O/W 수중유형 미셀 에멀전 (수분 크림·로션)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
생화학 신호전달 경로 (Biochemical Pathway Map)

세포·분자 타깃 작용 기전 플로우 다이어그램

1. 각질층·표피 작용→ 촉진·활성 (Activation)
각질층 세포간 지질 & 수분 결합 네트워크
→
경피수분손실(TEWL) 억제 및 피부결 개선
2. 염증 매개체 조절⊣ 억제·차단 (Inhibition)
외부 자극 유도 산화 스트레스(ROS) 및 사이토카인
⊣
피부 진정 및 항상성 유지

학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)

Tier 2 Synthesis

이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.

락토바실러스발효용해물(표준 INCI: LACTOBACILLUS FERMENT LYSATE, CAS 번호: N/A)은 화장품 처방에서 주로 피부컨디셔닝제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.1–5.0%(적정 pH 4.5–7.5) 범위에서 안정적으로 처방됩니다.

근거 동료심사 학술 논문 (미국 NIH PubMed) (6)

Lactobacillus and intestinal diseases: Mechanisms of action and clinical applications [PMID: 35421680 · 2022]
NIH PubMed Indexed Study · Microbiol Res (2022)

The gut microbial ecosystem, which is a collection of the host-microbiota interactions and the inter-species interplay among bacteria-dominated microbiota, has become a research hotspot due to its contribution to host health in recent years. Lactobacillus, which has worldwide usage in fermented dairy products, has aroused increasing attention and becomes one of the commonly used probiotics given its promising applications in intestinal health and disease, though it occupies a relatively small proportion of the intestinal microbiota. In the review, we first update the current understanding of determinants of Lactobacillus abundance in the intestinal tract. We then review evidence from animal models to human trials that provided insights into Lactobacillus's applications in common intestinal disorders including the Helicobacter pylori infection, colorectal cancer, diarrhea, inflammatory bowel disease, and irritable bowel syndrome. Mechanisms underlying the probiotic role of Lactobacillus are finally discussed in five aspects: microbial interactions, the improvement of intestinal barrier function, the immunoregulation, the anticancer activity, and the metabolic regulation. This review aims to yield a profound understanding of how Lactobacillus will contribute to disease prevention and individualized therapies in future clinical practice, and to inspire novel microbial strategies utilizing both probiotics and their products in the fields of biology and medicine.

Lactobacillus reuteri in digestive system diseases: focus on clinical trials and mechanisms [PMID: 37662007 · 2023]
NIH PubMed Indexed Study · Front Cell Infect Microbiol (2023)

Digestive system diseases have evolved into a growing global burden without sufficient therapeutic measures. Lactobacillus reuteri ( L. reuteri ) is considered as a new potential economical therapy for its probiotic effects in the gastrointestinal system. We have provided an overview of the researches supporting various L. reuteri strains' application in treating common digestive system diseases, including infantile colic, diarrhea, constipation, functional abdominal pain, Helicobacter pylori infection, inflammatory bowel disease, diverticulitis, colorectal cancer and liver diseases. The summarized literature in this review was derived from databases including PubMed, Web of Science, and Google Scholar. The therapeutic effects of L. reuteri in digestive system diseases may depend on various direct and indirect mechanisms, including metabolite production as well as modulation of the intestinal microbiome, preservation of the gut barrier function, and regulation of the host immune system. These actions are largely strain-specific and depend on the activation or inhibition of various certain signal pathways. It is well evidenced that L. reuteri can be effective both as a prophylactic measure and as a preferred therapy for infantile colic, and it can also be recommended as an adjuvant strategy to diarrhea, constipation, Helicobacter pylori infection in therapeutic settings. While preclinical studies have shown the probiotic potential of L. reuteri in the management of functional abdominal pain, inflammatory bowel disease, diverticulitis, colorectal cancer and liver diseases, its application in these disease settings still needs further study. This review focuses on the probiotic effects of L. reuteri on gut homeostasis via certain signaling pathways, and emphasizes the importance of these probiotics as a prospective treatment against several digestive system diseases.

Contribution of Lactobacillus iners to Vaginal Health and Diseases: A Systematic Review [PMID: 34881196 · 2021]
NIH PubMed Indexed Study · Front Cell Infect Microbiol (2021)

Lactobacillus iners , first described in 1999, is a prevalent bacterial species of the vaginal microbiome. As L. iners does not easily grow on de Man-Rogosa-Sharpe agar, but can grow anaerobically on blood agar, it has been initially overlooked by traditional culture methods. It was not until the wide application of molecular biology techniques that the function of L. iners in the vaginal microbiome was carefully explored. L. iners has the smallest genome among known Lactobacilli and it has many probiotic characteristics, but is partly different from other major vaginal Lactobacillus species, such as L. crispatus , in contributing to the maintenance of a healthy vaginal microbiome. It is not only commonly present in the healthy vagina but quite often recovered in high numbers in bacterial vaginosis (BV). Increasing evidence suggests that L. iners is a transitional species that colonizes after the vaginal environment is disturbed and offers overall less protection against vaginal dysbiosis and, subsequently, leads to BV, sexually transmitted infections, and adverse pregnancy outcomes. Accordingly, under certain conditions, L. iners is a genuine vaginal symbiont, but it also seems to be an opportunistic pathogen. Further studies are necessary to identify the exact role of this intriguing species in vaginal health and diseases.

Approach to probiotics in pediatrics: the role of Lactobacillus rhamnosus GG [PMID: 35068121 · 2022]
NIH PubMed Indexed Study · Arch Argent Pediatr (2022)

Preterm birth, C-sections, antibiotics, and limited breastfeeding contribute to the increase in noncommunicable diseases. Our objective was to perform a descriptive review of probiotic use in pediatrics, focused on Lactobacillus rhamnosus GG. Certain probiotics have demonstrated to be effective in acute diarrhea and antibiotic-associated diarrhea. L. rhamnosus GG and Saccharomyces boulardii may shorten their duration and symptoms. L. reuteri DSM 17938 and L. rhamnosus GG were effective to manage infant colic. The use of this strain in infant formulas for cow's milk protein allergy may promote an earlier tolerance acquisition. In relation to the prevention of atopic dermatitis, the administration of L. rhamnosus GG during pregnancy reduced its development in the infant. The use of probiotics as adjuvants is a possibility to consider in current pediatric practice. El parto prematuro, las ces&#xe1;reas, los antibi&#xf3;ticos y la lactancia materna limitada contribuyen al aumento de enfermedades cr&#xf3;nicas no transmisibles. El objetivo fue realizar una revisi&#xf3;n descriptiva del uso de probi&#xf3;ticos en pediatr&#xed;a, con foco en la cepa Lactobacillus rhamnosus GG. Ciertos probi&#xf3;ticos han demostrado ser eficaces en la diarrea aguda y en la diarrea asociada a antibi&#xf3;ticos. L. rhamnosus GG y Saccharomyces boulardii pueden acortar la duraci&#xf3;n y los s&#xed;ntomas. L. reuteri DSM 17938 y L. rhamnosus GG fueron efectivos para el abordaje del c&#xf3;lico del lactante. El uso de esta cepa en f&#xf3;rmulas infantiles para alergia a las prote&#xed;nas de leche de vaca promover&#xed;a la adquisici&#xf3;n m&#xe1;s temprana de tolerancia. En la prevenci&#xf3;n de dermatitis at&#xf3;pica, la administraci&#xf3;n de L. rhamnosus GG durante el embarazo redujo su manifestaci&#xf3;n en el beb&#xe9;. El empleo de probi&#xf3;ticos como coadyuvantes es una posibilidad para considerar en la pr&#xe1;ctica pedi&#xe1;trica actual.

Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial [PMID: 39102225 · 2024]
NIH PubMed Indexed Study · JAMA Pediatr (2024)

The effects of probiotic interventions on colonization with resistant bacteria and early microbiome development in preterm infants remain to be clarified. To examine the efficacy of Bifidobacterium longum subsp infantis, Bifidobacterium animalis subsp lactis (BB-12), and Lactobacillus acidophilus (La-5) probiotics to prevent colonization with multidrug-resistant organisms or highly epidemic bacteria (MDRO+) and to shape the microbiome of preterm infants toward the eubiotic state of healthy full-term infants. The multicenter, double-blinded, placebo-controlled, group sequential, phase 3 Priming Immunity at the Beginning of Life (PRIMAL) randomized clinical trial, conducted from April 2018 to June 2020, included infants with gestational age of 28 to 32 weeks at 18 German neonatal units. Data analyses were conducted from March 2020 to August 2023. A total of 28 days of multistrain probiotics diluted in human milk/formula starting within the first 72 hours of life. Colonization with MDRO+ at day 30 of life (primary end point), late-onset sepsis and severe gastrointestinal complication (safety end points), and gut dysbiosis, ie, deviations from the microbiome of healthy, term infants (eubiosis score) based on 16-subunit ribosomal RNA and metagenomic sequencing. Among the 643 infants randomized until the stop of recruitment based on interim results, 618 (median [IQR] gestational age, 31.0 [29.7-32.1] weeks; 333 male [53.9%]; mean [SD] birth weight, 1502 [369] g) had follow-up at day 30. The interim analysis with all available data from 219 infants revealed MDRO+ colonization in 43 of 115 infants (37.4%) in the probiotics group and in 39 of 104 infants (37.5%) in the control group (adjusted risk ratio, 0.99; 95% CI, 0.54-1.81; P&#x2009;=&#x2009;.97). Safety outcomes were similar in both groups, ie, late-onset sepsis (probiotics group: 8 of 316 infants [2.5%]; control group: 12 of 322 infants [3.7%]) and severe gastrointestinal complications (probiotics group: 6 of 316 infants [1.9%]; control group: 7 of 322 infants [2.2%]). The probiotics group had higher eubiosis scores than the control group at the genus level (254 vs 258 infants; median scores, 0.47 vs 0.41; odds ratio [OR], 1.07; 95% CI, 1.02-1.13) and species level (96 vs 83 infants; median scores, 0.87 vs 0.59; OR, 1.28; 95% CI, 1.19-1.38). Environmental uptake of the B infantis probiotic strain in the control group was common (41 of 84 [49%]), which was highly variable across sites and particularly occurred in infants with a sibling who was treated with probiotics. Multistrain probiotics did not reduce the incidence of MDRO+ colonization at day 30 of life in preterm infants but modulated their microbiome toward eubiosis. German Clinical Trials Register: DRKS00013197.

Orally administrated Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 can restore the vaginal health of patients recovering from bacterial vaginosis [PMID: 37575226 · 2023]
NIH PubMed Indexed Study · Front Immunol (2023)

Bacterial vaginosis (BV) is a common infection of the lower genital tract with a vaginal microbiome dysbiosis caused by decreasing of lactobacilli. Previous studies suggested that supplementation with live Lactobacillus may benefit the recovery of BV, however, the outcomes vary in people from different regions. Herein, we aim to evaluate the effectiveness of oral Chinese-origin Lactobacillus with adjuvant metronidazole (MET) on treating Chinese BV patients. In total, 67 Chinese women with BV were enrolled in this parallel controlled trial and randomly assigned to two study groups: a control group treated with MET vaginal suppositories for 7 days and a probiotic group treated with oral Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 as an adjuvant to MET for 30 days. By comparing the participants with Nugent Scores &#x2265; 7 and &lt; 7 on days 14, 30, and 90, we found that oral administration of probiotics did not improve BV cure rates (72.73% and 84.00% at day 14, 57.14% and 60.00% at day 30, 32.14% and 48.39% at day 90 for probiotic and control group respectively). However, the probiotics were effective in restoring vaginal health after cure by showing higher proportion of participants with Nugent Scores &lt; 4 in the probiotic group compared to the control group (87.50% and 71.43% on day 14, 93.75% and 88.89% on day 30, and 77.78% and 66.67% on day 90). The relative abundance of the probiotic strains was significantly increased in the intestinal microbiome of the probiotic group compared to the control group at day 14, but no significance was detected after 30 and 90 days. Also, the probiotics were not detected in vaginal microbiome, suggesting that L. gasseri TM13 and L. crispatus LG55 mainly acted through the intestine. A higher abundance of Prevotella timonensis at baseline was significantly associated with long-term cure failure of BV and greatly contributed to the enrichment of the lipid IVA synthesis pathway, which could aggravate inflammation response. To sum up, L. gasseri TM13 and L. crispatus LG55 can restore the vaginal health of patients recovering from BV, and individualized intervention mode should be developed to restore the vaginal health of patients recovering from BV. https://classic.clinicaltrials.gov/ct2/show/, identifier NCT04771728.

자주 묻는 질문 (AEO 스니펫 최적화 FAQ)

Q1. 락토바실러스발효용해물 (LACTOBACILLUS FERMENT LYSATE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
한국 식약처 표준명은 '락토바실러스발효용해물', 미국 PCPC 및 유럽 CosIng INCI 표기는 'LACTOBACILLUS FERMENT LYSATE', 중국 NMPA IECIC 표준명은 '乳酸杆菌发酵溶胞产物', 일본 화장품 표시명칭은 'LACTOBACILLUS FERMENT LYSATE'입니다.
Q2. 락토바실러스발효용해물의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: none), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
Q3. 제형 설계 시 락토바실러스발효용해물의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
일반 스킨케어 제형에서 적정 pH 4.5~7.5 구간에서 안정적으로 배합됩니다.
Q4. 락토바실러스발효용해물 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
주요 권장 시너지 조합은 판테놀, 세라마이드엔피, 하이드롤라이즈드해면이며, 배합 주의사항은 극단적 강산/강염기 조건 회피입니다.