POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
化妆品中 聚甘油-3 甲基葡糖二硬脂酸酯 (POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE) 的全球法规限值与配方应用标准是什么?
聚甘油-3 甲基葡糖二硬脂酸酯(标准 INCI: POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE,CAS 号: N/A)是化妆品配方中主要用作乳化剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(未列管)及欧盟 CosIng(未列管)等 6 大法域法定标准监管,常规建议添加量为 1–4%(最佳稳定窗口 pH 4.5–8.5)。
全球 7 轨官方全成分标签名称对照表
严格采用各国政府官方目录原名 · 严禁机器翻译| 法域与监管轨道 | 官方公告全成分标准名称 | 一键复制 |
|---|---|---|
| ① 韩国 (MFDS 化妆品标准名称) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | Former KR Nomenclature Redirect Active | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | |
| ⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC) | — (非美国 OTC 专论活性成分 / 普通化妆品原料) | — |
| ⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名) | 聚甘油-3 甲基葡糖二硬脂酸酯 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (标准 INCI 参照) |
Layer 1 — 全球 6 大法域法定限值与监管状态
| 法域 | 监管状态 | 法定限值 | 适用条件与法定依据来源 |
|---|---|---|---|
| 韩国 (MFDS) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 已使用/准用 | GMP | IECIC Entry #3830 |
| 日本 (MHLW) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 东盟 (ACD) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
Layer 2 — 毒理评估与历史最高使用量 (CN IECIC / US CIR / EU SCCS)
“欧盟 SCCS 安全评估上限”代表消费者安全科学委员会判定安全边际 (MoS≥100) 的毒理阈值;“美国 CIR 市售最高报告浓度”与“中国 IECIC 最高历史使用量”代表已上市化妆品的最高实际使用浓度。
| 安全评估依据 | 适用范围与剂型 | 评估浓度范围 | 评估结论与文献档案 |
|---|---|---|---|
| 中国 IECIC 最高历史使用量 | leave_on | ≤ 6% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03628 (2025) |
| 中国 IECIC 最高历史使用量 | 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 — 剂型常规配比指南与理化配伍性
| 剂型分类 | Min – Q1 – Median – Q3 – Max (%) | 配方作用与机理 | Source ID |
|---|---|---|---|
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 1% · 1.8% · 2.5% · 3% · 4% | PEG-free O/W primary lamellar emulsifier | Evonik TEGO Care 450 TDS & Formulation Library (n=195) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 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.
商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。
学术与毒理综合摘要
Tier 1 Synthesis本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。
关联同行评审文献 (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.
常见问题解答 (FAQ)
- Q1. 聚甘油-3 甲基葡糖二硬脂酸酯 (POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE) 在全球 7 大法域的官方全成分标签名称是什么?
- 中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 '聚甘油-3 甲基葡糖二硬脂酸酯',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE',日本 JCIA 表示名称为 'POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE'。
- Q2. 聚甘油-3 甲基葡糖二硬脂酸酯 (POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
- 6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): none,欧盟(EU): none,美国(US): none,日本(JP): none,东盟(ASEAN): none。
- Q3. 聚甘油-3 甲基葡糖二硬脂酸酯 (POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
- 在代表性剂型 (emulsion_cream) 中常规添加量为 1%–4%(中位数 2.5%),最佳稳定 pH 范围为 4.5–8.5。
- Q4. 聚甘油-3 甲基葡糖二硬脂酸酯 (POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 CETEARYL ALCOHOL, GLYCERYL STEARATE, SODIUM STEAROYL GLUTAMATE, CAPRYLIC/CAPRIC TRIGLYCERIDE;配伍禁忌注意:Emulsification below 70°C may lead to incomplete liquid crystal formation and viscosity drift。