BIFIDA FERMENT LYSATE
化粧品における BIFIDA FERMENT LYSATE のグローバル配合基準と処方特性とは?
BIFIDA FERMENT LYSATE(CAS番号: 96507-89-0)は、化粧品処方において主に皮膚コンディショニング剤として配合される原料です。日本厚労省/JCIA(規制なし)、韓国MFDS(規制なし)、欧州CosIng(規制なし)など6大法域の法定基準下で管理され、通常 1–50%(適正安定域 pH 4.5–6.8)で処方されます。
7大トラック 国別・用途別 公式全成分表示名称マトリクス
各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ| 法域・規制トラック | 公式全成分表示名称 | ワンクリックコピー |
|---|---|---|
| ① 韓国 (MFDS 化粧品標準名称) | BIFIDA FERMENT LYSATE (KR MFDS Registered) | |
| ② 韓国旧名称履歴 (301 リダイレクト) | — | — |
| ③ 欧州連合 (EU CosIng EC 1223/2009) | BIFIDA FERMENT LYSATE | |
| ④ 米国一般化粧品 (US PCPC / MoCRA INCI) | BIFIDA FERMENT LYSATE | |
| ⑤ 米国 FDA OTC モノグラフ有効成分名 | — (米国 OTC 対象外 / 一般化粧品原料) | — |
| ⑥ 中国 (NMPA IECIC 標準中国語名称) | 二裂酵母发酵产物溶胞产物 | |
| ⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW) | BIFIDA FERMENT LYSATE (標準INCI参照 · 任意カタカナ音訳排除) |
Layer 1 — 6大法域 法定配合上限および規制ステータス
| 法域 | 規制ステータス | 配合上限 | 制限条件および一次法源出典 |
|---|---|---|---|
| 韓国 (MFDS) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 欧州 (EU) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 米国 (FDA) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 中国 (NMPA) | 配合可能 | GMP | IECIC Entry #2162 |
| 日本 (MHLW) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| ASEAN (ACD) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)
「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。
| 安全性評価基準 | 適用範囲・用途 | 安全濃度範囲 | 判定結果および文献参照 |
|---|---|---|---|
| 中国 IECIC 最高歴史使用量 | leave_on | ≤ 50% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 02115 (2025) |
| 中国 IECIC 最高歴史使用量 | rinse_off | ≤ 10% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 02115 (2025) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剤形別通常配合濃度 (四分位数 n≥5) & 物理化学・相溶性ガイド
| 剤形グループ | Min – Q1 – Median – Q3 – Max (%) | 処方役割・作用機序 | Source ID |
|---|---|---|---|
| 剤形群 A — 水성化粧水・美容液・アンプル | 1% · 3% · 10% · 25% · 50% | Postbiotic lysate enhancing UV-induced DNA repair & barrier immunity | CLR Repair Complex CLR PF Monograph & PubMed Clinical Trials |
| 剤形群 B — 乳液・エマルジョン・クリーム | 1% · 2% · 5% · 10% · 20% | Night repair & microbiome barrier-strengthening cream active | CLR Berlin Technical Dossier & CN IECIC |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4.5–6.8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermolabile active: Must be added during post-emulsification Cool-down Phase (<40–45°C).
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名は研究者がグレードを識別するための参考表記であり、各商標権は原メーカーに帰属します。
学術・毒性・処方統合モノグラフ
Tier 1 Synthesis本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。
関連査読付き学術論文 (NIH PubMed) (3)
Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage [PMID: 38951050 · 2024]
The global facial mask market grows steadily at 8.5 % annually. However, prolonged use may lead to skin inflammation. To investigate how various mask types and wearing durations impact skin physiology and aquaporins3 (AQP3) expression in healthy subjects. We used a randomized controlled design to investigate the effects of three types of facial masks (pure water, hyaluronan, and bifida ferment lysate) and four different duration(5, 15, 25, and 40 min) on various skin parameters in volunteers, assessing moisture content, transepidermal water loss (TEWL), sebum, corneocyte size, and AQP3 expression before and after mask application, while also evaluating adverse reactions, discomfort, and noncompliance. Hydration and TEWL increased at first, then decreased. Sebum increased with all types of masks, particularly after 40 min. Vasodilation and AQP3 expression were linked to mask duration. Corneocyte sizes remained constant. The main adverse reactions were redness (10.71 %, n = 28) and dryness (57.14 %, n = 28), especially with pure water masks lasting over 25 min. Short-term use of facial sheet masks (<25 min) benefits skin with improved hydration, reduced redness, and AQP3 activation, while prolonged use can lead to increased dryness and redness.
The pivotal role of Bifida Ferment Lysate on reinforcing the skin barrier function and maintaining homeostasis of skin defenses in vitro [PMID: 37218728 · 2023]
The semiactive or inactive probiotics or their extracts used in dermatology have interesting properties to ameliorate signs of irritated skin and enhance the skin barrier. Bifidobacterium, as the most common probiotics, which has been found to be effective in reducing acne and improving the skin barrier function of atopic dermatitis. Bifida Ferment Lysate (BFL) can be obtained from Bifidobacterium by fermentation and extraction. In this study, we investigated the effect of a topically used BFL on the skin using in vitro evaluation methods. The results showed that upregulation of skin physical barrier gene (FLG, LOR, IVL, TGM1, and AQP3) and antimicrobial peptide gene (CAMP and hBD-2) in HaCaT cells by BFL might be responsible for skin barrier resistance. In addition, BFL had strong antioxidant properties representing a dose-dependent increasing of the scavenging capacity of DPPH, ABTS, hydroxyl, and superoxide radicals. BFL treatment also fundamentally inhibited the intracellular ROS and MDA production and improved the activities of antioxidant enzymes (CAT and GSH-Px) in H 2 O 2 -stimulated HaCaT cells. As a good immunomodulatory factor, BFL efficiently decreased the secretion of IL-8 and TNF-α cytokines, and COX-2 mRNA expression in LPS-induced THP-1 macrophages. BFL can strengthen the skin barrier function and stimulate skin barrier resistance, to reinforce the skin against oxidative stress and inflammatory stimuli.
A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne [PMID: 35861908 · 2022]
Several options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions. A randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged ≥ 16 years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2 months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t 0 ) and after 2 months of treatment (t 1 ), and the results were compared between groups. Digital photographic images were also taken. Sixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2 months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated. It was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.
よくある質問 (FAQ)
- Q1. BIFIDA FERMENT LYSATE の各国公式全成分表示名称(7トラック)はどのように異なりますか?
- 日本化粧品工業連合会(JCIA)表示名称は 'BIFIDA FERMENT LYSATE (標準INCI準拠)'、米国PCPC・欧州CosIng INCIは 'BIFIDA FERMENT LYSATE'、中国NMPA IECIC標準中国語名は '二裂酵母发酵产物溶胞产物' です。
- Q2. BIFIDA FERMENT LYSATE のグローバル6大法域における法定配合基準 (Layer 1) は?
- 6大法域規制ステータス — 日本(JP): none、韓国(KR): none、欧州(EU): none、米国(US): none、中国(CN): allowed、ASEAN: none。
- Q3. 処方設計における BIFIDA FERMENT LYSATE の通常配合濃度 (Layer 3) と適正 pH は?
- 主要剤形 (aqueous_serum) において通常 1〜50%(中央値 10%)で配合され、適正pH範囲は 4.5〜6.8 です。
- Q4. BIFIDA FERMENT LYSATE の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
- 推奨シナジーペアは GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS FERMENT LYSATE, NIACINAMIDE, ADENOSINE、配合上の注意点は Rich in organic acid metabolites and amino-acid electrolytes that collapse standard Carbomer gels; use SEPIMAX ZEN or Xanthan Gum; High levels (>10%) require robust preservation (e.g., 2.0% 1,2-Hexanediol + 0.05% Ethylhexylglycerin) です。