POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
化粧品における POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE のグローバル配合基準と処方特性とは?
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE(CAS番号: N/A)は、化粧品処方において主に乳化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 1–4%(適正安定域 pH 4.5–8.5)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) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (KR MFDS Registered) | |
| ② 韓国旧名称履歴 (301 リダイレクト) | Former KR Nomenclature Redirect Active | — |
| ③ 欧州連合 (EU CosIng EC 1223/2009) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | |
| ④ 米国一般化粧品 (US PCPC / MoCRA INCI) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | |
| 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) | 聚甘油-3 甲基葡糖二硬脂酸酯 | |
| ⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (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 #3830 |
| 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 | ≤ 6% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03628 (2025) |
| 中国 IECIC 最高歴史使用量 | rinse_off | ≤ 5% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03628 (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 B — 乳液・エマルジョン・クリーム | 1% · 1.8% · 2.5% · 3% · 4% | PEG-free O/W primary lamellar emulsifier | Evonik TEGO Care 450 TDS & Formulation Library (n=195) |
| 剤形群 D — 日焼け止め (UV)・メイクアップ・ファンデーション | 1% · 1.5% · 2% · 3% · 4% | O/W sunscreen & tone-up cream emulsifier | Evonik TEGO Care 450 Sunscreen Guide |
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 4.5–8.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 85°C during standard emulsification.
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)
Phytoformulation of Sassurea lappa plant extract: A Single blind, noninvasive and split face study of cream on various skin parameters [PMID: 29105631 · 2017]
Saussurea lappa (SL) has been reported for its antioxidant and anti-ageing properties. Due to this reason it can be incorporated in a stable phytoformulations for cosmetic use. The objective of the study was to evaluate the anti-aging potential of cosmetic o/w emulsion containing the botanical extract of SL. An emulsion (o/w) was prepared using TEGO® Care 450 (Polyglceryl-3-Methyl Glucose Distearate) emulsifier and final emulsion was loaded with 4 % extract of SL in aqueous phase. This emulsion evaluated for its antioxidant and anti-ageing properties on healthy human subjects using a non-invasive technique called surface evaluation of living skin (SELS). The formulation containing SL extract showed significant (p<0.05) changes in Skin roughness (SEr) as -3.13%, -6.26%, -9.39%; Skin Scaliness (SEsc) as - 4.19%, -8.39%, -12.58%; Skin wrinkles (SEw) as -0.5%, -1.08%, -1.63%; and Skin smoothness (SEsm) as 3.28%, 6.57%, 9.85%, respectively, after 30, 60 and 90 days of continous use. Topical application of the cosmetic cream containing SL extract exerts have a significant anti-aging effects, perhaps due to the presence of Kaempferol, gallic acid, Caffeic acid and other essential phenolics.
Influence of processing conditions in the manufacture of O/W creams: II. Effect on drug availability [PMID: 12058808 · 2002]
O/W creams prepared in three mechanical conditions (F with a hand blender; S turbomixer; T vacuum turbo-emulsor) produced different dispersion grades of the internal phase and different rheological characteristics by using surfactants of different chemical nature (polyoxyethylene-cetostearyl alcohols and polyglyceryl-3-methylglucose distearate). Three tests were used (an in vitro release test across a porous membrane; an in vitro simulated absorption test across a porous membrane impregnated with isopropyl myristate; an in vivo absorption test based on the intensity and duration of the erythema produced by methyl nicotinate after application of the cream on the skin) to assess whether the different physical characteristics influence drug availability from the creams. The different physical characteristics due to the mechanical conditions of emulsifying and gelification appeared not to influence drug release and in vivo absorption.
Influence of processing conditions in the manufacture of O/W creams: I. Effect on dispersion grade and rheological characteristics [PMID: 12058807 · 2002]
Two series of O/W creams having the same general formulation were prepared in three different mechanical conditions (F with an hand blender; S with a turbomixer; T with a vacuum turbo emulsor) using two types of surfactants, polyoxyethylene-cetostearyl alcohols and polyglyceryl-3-methylglucose-distearate. By means of microscopic image analysis it was possible to point out the dispersion grade of the oil internal phase increasing with the energy applied under the conditions of manufacture (F < S < T). The level of dispersion influenced significantly on the rheological characteristics of the creams. With polyoxyethylene-cetostearyl alcohols, the viscosity of creams increased as the energy applied in manufacturing increased, with polyglyceryl-3-methylglucose-distearate on the contrary decreased. Moreover, indifferently to the manufacturing conditions, even in the same concentration of surfactant, the creams obtained with the last produced a much greater viscosity. At a parity of manufacturing conditions the differences between the batches of productions were not significant.
よくある質問 (FAQ)
- Q1. POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 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 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (標準INCI準拠)'、米国PCPC・欧州CosIng INCIは 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE'、中国NMPA IECIC標準中国語名は '聚甘油-3 甲基葡糖二硬脂酸酯' です。
- Q2. POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 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 POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE の通常配合濃度 (Layer 3) と適正 pH は?
- 主要剤形 (emulsion_cream) において通常 1〜4%(中央値 2.5%)で配合され、適正pH範囲は 4.5〜8.5 です。
- Q4. POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 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 CETEARYL ALCOHOL, GLYCERYL STEARATE, SODIUM STEAROYL GLUTAMATE, CAPRYLIC/CAPRIC TRIGLYCERIDE、配合上の注意点は Emulsification below 70°C may lead to incomplete liquid crystal formation and viscosity drift です。