化学合成 (Synthetic)
POLYMETHYLSILSESQUIOXANE
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 聚甲基倍半硅氧烷 (序号 #3962)
遮光剂
[EU CosIng Official Definition] Polymer formed by hydrolysis and condensation of methyltrimethoxysilane
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR
化妆品中 聚甲基倍半硅氧烷 (POLYMETHYLSILSESQUIOXANE) 的全球法规限值与配方应用标准是什么？
聚甲基倍半硅氧烷（标准 INCI: POLYMETHYLSILSESQUIOXANE，CAS 号: 68554-70-1）是化妆品配方中主要用作遮光剂的核心成分。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 2–15%（最佳稳定窗口 pH 4–8）。
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) | POLYMETHYLSILSESQUIOXANE (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) | POLYMETHYLSILSESQUIOXANE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | POLYMETHYLSILSESQUIOXANE | |
| 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) | 聚甲基倍半硅氧烷 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | POLYMETHYLSILSESQUIOXANE (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 #3962 |
| 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) |
⚠️ 仅供参考 (免责声明): 本词典中的原料名称、法规限值与配比指南仅供研发参考。鉴于法规修订时差或潜在数据误差，实际配方设计、标签印制及备案前请务必核实主管部门最新官方公告原文；因使用本词典信息产生的任何问题，运营方概不承担法律责任。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Aqueous Serum / Ampoulen=19
Min 2% · Q1 4% · Median 5% · Q3 5% · Max 15%
Emulsion / Creamn=33
Min 2% · Q1 2% · Median 4% · Q3 5% · Max 10%
Sunscreen / Colorn=47
Min 1% · Q1 3% · Median 5% · Q3 5.85% · Max 12%
Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component
Verified Source: Global Starter Formulation Library Statistical Distribution (n=19, GRANT 19) (cir_safety) · GRANT 19
Typical Median: 5%
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 A — 水剂爽肤水 / 精华液 / 安瓶 | 2% · 4% · 5% · 5% · 15% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=19, GRANT 19) |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 2% · 2% · 4% · 5% · 10% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=33, GRANT 33) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 1% · 3% · 5% · 5.85% · 12% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=47, GRANT 47) |
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability
Water or glycol phase soluble/dispersiblepH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 50°C
Thermally stable up to 50°C during standard emulsification.
HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
Biochemical Signaling & Mechanism Pathway
Cellular & Molecular Target Mechanism Flow
1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Interactive Node Guide
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
代表性商品名参考 (商标法第90条第1款第2项说明性标示)
POLYMETHYLSILSESQUIOXANE
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。
■ [1. Chemical Identity & International Labeling Nomenclature]
- INCI Name: POLYMETHYLSILSESQUIOXANE | CAS No.: 68554-70-1 | EC No.: N/A
- Origin: SYNTHETIC | Functions:
- Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS
- Official Regional Label Names: US [POLYMETHYLSILSESQUIOXANE] · EU [POLYMETHYLSILSESQUIOXANE] · CN [聚甲基倍半硅氧烷] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- Polymer formed by hydrolysis and condensation of methyltrimethoxysilane Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
- Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 3962 (聚甲基倍半硅氧烷))
- No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
- Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [aqueous_serum] Typical range: 2.0 ~ 15.0% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=19, GRANT 19)) — Aqueous serum, toner & hydrogel matrix formulation component
- [emulsion_cream] Typical range: 2.0 ~ 10.0% (Median 4.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=33, GRANT 33)) — Emulsion cream & lotion structural / conditioning agent
- [sun_color] Typical range: 1.0 ~ 12.0% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=47, GRANT 47)) — Sun care & color cosmetics dispersion / sensory modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
- Addition Phase: Water Phase or Cool-down Phase (< 45°C)
- Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
- Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
- Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: POLYMETHYLSILSESQUIOXANE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- PMID 25427646 (2014, Biofabrication): Novel preparation of controlled porosity particle/fibre loaded scaffolds using a hybrid micro-fluidic and electrohydrody
关联同行评审文献 (NIH PubMed) (1)
Novel preparation of controlled porosity particle/fibre loaded scaffolds using a hybrid micro-fluidic and electrohydrodynamic technique. [PMID: 25427646 · 2014]
Parhizkar M, Sofokleous P, Stride E, Edirisinghe M · Biofabrication (2014)
The purpose of this research was to produce multi-dimensional scaffolds containing biocompatible particles and fibres. To achieve this, two techniques were combined and used: T-Junction microfluidics and electrohydrodynamic (EHD) processing. The former was used to form layers of monodispersed bovine serum albumin (BSA) bubbles, which upon drying formed porous scaffolds. By altering the T-Junction processing parameters, bubbles with different diameters were produced and hence the scaffold porosity could be controlled. EHD processing was used to spray or spin poly(lactic-co-glycolic) (PLGA), polymethysilsesquioxane (PMSQ) and collagen particles/fibres onto the scaffolds during their production and after drying. As a result, multifunctional BSA scaffolds with controlled porosity containing PLGA, PMSQ and collagen particles/fibres were obtained. Product morphology was studied by optical and scanning electron microscopy. These products have potential applications in many advanced biomedical, pharmaceutical and cosmetic fields e.g. bone regeneration, drug delivery, cosmetic cream lathers, facial scrubbing creams etc.
常见问题解答 (FAQ)
- Q1. 聚甲基倍半硅氧烷 (POLYMETHYLSILSESQUIOXANE) 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 '聚甲基倍半硅氧烷'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'POLYMETHYLSILSESQUIOXANE'，日本 JCIA 表示名称为 'POLYMETHYLSILSESQUIOXANE'。
- Q2. 聚甲基倍半硅氧烷 (POLYMETHYLSILSESQUIOXANE) 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. 聚甲基倍半硅氧烷 (POLYMETHYLSILSESQUIOXANE) 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 (aqueous_serum) 中常规添加量为 2%–15%（中位数 5%），最佳稳定 pH 范围为 4–8。
- Q4. 聚甲基倍半硅氧烷 (POLYMETHYLSILSESQUIOXANE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合？
- 推荐协同组合包括 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL；配伍禁忌注意：Verify phase compatibility under extreme pH or high electrolyte loads。