原料词典检索/glyceryl-stearate/GLYCERYL STEARATE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
化学合成 (Synthetic)

GLYCERYL STEARATE

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 甘油硬脂酸酯 (序号 #2490)
柔润剂乳化剂
[EU CosIng Official Definition] Stearic acid, monoester with glycerol
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 甘油硬脂酸酯 (GLYCERYL STEARATE) 的全球法规限值与配方应用标准是什么?

甘油硬脂酸酯(标准 INCI: GLYCERYL STEARATE,CAS 号: 31566-31-1)是化妆品配方中主要用作柔润剂, 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 0.5–5%(最佳稳定窗口 pH 4–9)。

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
7-Track Official Statutory Label Names for GLYCERYL STEARATE
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)GLYCERYL STEARATE (KR MFDS Registered)
② 韩国旧名称历史 (301 重定向)——
③ 欧盟 (EU CosIng EC 1223/2009)GLYCERYL STEARATE
④ 美国普通化妆品 (US PCPC / MoCRA INCI)GLYCERYL STEARATE
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)甘油硬脂酸酯
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)ステアリン酸グリセリル · [QD: モノステアリン酸グリセリル]

Layer 1 — 全球 6 大法域法定限值与监管状态

Layer 1 Statutory Regulatory Limits Across 6 Regions for GLYCERYL STEARATE
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GMPIECIC Entry #2490
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。

Layer 2 Toxicological & Historical Safe Use Concentrations for GLYCERYL STEARATE
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≤ 15%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 02375 (2025)
中国 IECIC 最高历史使用量rinse_off≤ 10%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 02375 (2025)
⚠️ 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

Emulsion / Creamn=312
Min 0.5% · Q1 1.2% · Median 2% · Q3 3% · Max 5%
Anhydrous Balm / Oiln=11
Min 0.5% · Q1 2% · Median 3% · Q3 3% · Max 5%
Aqueous Serum / Ampoulen=11
Min 0.5% · Q1 0.5% · Median 1% · Q3 1.75% · Max 6%
Rinse-off Cleansern=10
Min 1% · Q1 1.25% · Median 2% · Q3 2% · Max 6%
Sunscreen / Colorn=31
Min 0.1% · Q1 0.425% · Median 1% · Q3 2% · Max 4.8%
Emulsion / Cream — O/W co-emulsifier, consistency factor & lamellar body builder
Verified Source: Evonik TEGIN M / Arlacel 165 TDS & CIR Reported Use (cir_safety) · Evonik 184 · SEPPIC 72 · Croda 56
Typical Median: 2%

Layer 3 — 剂型常规配比指南与理化配伍性

Layer 3 Formulation Concentration Quartiles by Product Category for GLYCERYL STEARATE
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)0.5% · 1.2% · 2% · 3% · 5%O/W co-emulsifier, consistency factor & lamellar body builderEvonik TEGIN M / Arlacel 165 TDS & CIR Reported Use
剂型组 E — 无水精油 / 固体膏霜 / 唇部护理0.5% · 2% · 3% · 3% · 5%Anhydrous balm, oil & stick structural emollientGlobal Starter Formulation Library Statistical Distribution (n=11, EVONIK 7 · SEPPIC 2 · ELEMENTIS 1 · GRANT 1)
剂型组 A — 水剂爽肤水 / 精华液 / 安瓶0.5% · 0.5% · 1% · 1.75% · 6%Aqueous serum, toner & hydrogel matrix formulation componentGlobal Starter Formulation Library Statistical Distribution (n=11, EVONIK 7 · ELEMENTIS 3 · GRANT 1)
剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露1% · 1.25% · 2% · 2% · 6%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=10, EVONIK 4 · SEPPIC 4 · ELEMENTIS 2)
剂型组 D — 防晒霜 / 彩妆 / 粉底0.1% · 0.425% · 1% · 2% · 4.8%Sun care & color cosmetics dispersion / sensory modifierGlobal Starter Formulation Library Statistical Distribution (n=31, EVONIK 25 · GRANT 3 · SEPPIC 2 · ELEMENTIS 1)
Cutaneous Permeation Science (500 Dalton Rule)MW: 358.56 Da · LogP: 6.9

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (358.56 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
O/W Emulsion / Micelle
Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Oil soluble (melts at 58~63°C)
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 9.0
0245.5791114

Outside pH 4–9, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 85°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 85°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
W/O Inverse Micelle Emulsion (Rich Balm / Mineral UV)
HLB 3.8
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)W/O Inverse Micelle
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)

+ PEG-100 STEARATE+ CETEARYL ALCOHOL+ POLYGLYCERYL-3 MET…✕ Do not confuse pure …GLYCERYL STEARATE
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)
Arlacel™ 165 (with PEG-100 Stearate)SIMULSOL™ 165TEGIN® MCutina® GMS V

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: GLYCERYL STEARATE | CAS No.: 31566-31-1 | EC No.: 250-705-4 - Origin: SYNTHETIC | Functions: , - Physicochemical Profile: Formula C21H42O4 | MW 358.56 g/mol | LogP 6.9 | Ionic Nature: non-ionic | PubChem CID 24699 - Official Regional Label Names: US [GLYCERYL STEARATE] · EU [GLYCERYL STEARATE] · CN [甘油硬脂酸酯] · JP [ステアリン酸グリセリル] · JP Quasi-Drug [モノステアリン酸グリセリル] ■ [2. Dermatological Mechanism of Action & Functional Role] - Stearic acid, monoester with glycerol 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. 2490 (甘油硬脂酸酯)) - 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): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 15.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 10.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [emulsion_cream] Typical range: 0.5 ~ 5.0% (Median 2.0%, Ref: Evonik TEGIN M / Arlacel 165 TDS & CIR Reported Use) — O/W co-emulsifier, consistency factor & lamellar body builder - [anhydrous_balm] Typical range: 0.5 ~ 5.0% (Median 3.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=11, EVONIK 7 · SEPPIC 2 · ELEMENTIS 1 · GRANT 1)) — Anhydrous balm, oil & stick structural emollient - [aqueous_serum] Typical range: 0.5 ~ 6.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=11, EVONIK 7 · ELEMENTIS 3 · GRANT 1)) — Aqueous serum, toner & hydrogel matrix formulation component ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Oil Phase (Heat to 75~80°C) - Optimal pH Range: pH 4.0 ~ 9.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: Do not confuse pure non-ionic Glyceryl Stearate (HLB ~3.8) with Glyceryl Stearate SE (contains potassium/sodium stearate soap; breaks at pH < 6.8) - Synergy Pairings: PEG-100 STEARATE, CETEARYL ALCOHOL, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE | Reference Trade Names: Arlacel™ 165 (with PEG-100 Stearate), SIMULSOL™ 165, TEGIN® M, Cutina® GMS V ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 41235541 (2026, Int J Cosmet Sci): Minimalist, bioinspired and sensorial emulsion based on a Ca(2+) double cone vector system using Design of Experiment (D - PMID 40739062 (2025, AAPS PharmSciTech): Rational QbD-based Assessment of Formulation Ingredients' Impact on Sustainable Sunscreen Physical Stability - PMID 40603073 (2025, J Oleo Sci): Preparation and Characterization of Emulsifier-free, Submicron-sized Monodisperse Rice Bran Wax Particles and their Appl

关联同行评审文献 (NIH PubMed) (12)

Minimalist, bioinspired and sensorial emulsion based on a Ca(2+) double cone vector system using Design of Experiment (DoE) [PMID: 41235541 · 2026]
Lavarde M, Lassalle M, Gouot S, Corroyer Y, Marceau C, Briffaut V, Poigny S, Issa S · Int J Cosmet Sci (2026)

Innovation is considered a determining factor in the highly competitive environment of the cosmetic industry to introduce products while creating new needs. The goal of the study consisted of developing a highly natural and minimalist emulsion with sensorially pleasant skin application highlighted by an innovative ingredient based on a Ca 2+ double cone vector system. The desired product characteristics include a creamy, white texture that is not too greasy or excessively whitening, with rapid skin penetration to facilitate its use for skin treatment. To determine the ideal composition of the emulsion, a design of experiment (DoE) based strategy was applied in two steps: a screening step followed by optimisation. The screening step aimed to identify the key potential ingredients and process parameters that have a significant impact on the rheological and textural properties of the emulsion. The optimisation step provided the final emulsion formula with the desired physicochemical parameters and sensory characteristics. After rheological and sensory analysis, the screening of different ingredients revealed that the combination of 0.8% xanthan gum as the thickening&#xa0;agent (TA), glyceryl stearate citrate and polyglyceryl-3 stearate and hydrogenated lecithin as surfactant S1, and 1% of a mixture of C15-19 alkane (plant-based and renewable) - coco-caprylate/caprate as the sensory agent (SA1) provided the best sensorial qualities for the emulsion. The study demonstrated&#xa0;that the deflocculating rod met one of optimisation's target criteria through its process effect. Based on DoE, the final formulation resulted in a visually white formulation that was neither too greasy nor excessively whitening and highly penetrative of the skin, offering a comfortable face or body cream application for adults and children. L'innovation est consid&#xe9;r&#xe9;e comme un facteur d&#xe9;terminant dans l'environnement hautement concurrentiel de l'industrie cosm&#xe9;tique, permettant&#xa0;d'introduire de nouveaux produits tout en cr&#xe9;ant de nouveaux besoins. L'objectif de cette &#xe9;tude est de d&#xe9;velopper une &#xe9;mulsion tr&#xe8;s naturelle et minimaliste, offrant une application sensorielle agr&#xe9;able sur la peau, mise en&#xa0;valeur par un ingr&#xe9;dient innovant bas&#xe9; sur un syst&#xe8;me vecteur en double c&#xf4;ne&#xa0;de Ca 2+ . Les caract&#xe9;ristiques recherch&#xe9;es pour le produit incluent une texture cr&#xe9;meuse et blanche, pas trop grasse, ni excessivement blanchissante, avec une p&#xe9;n&#xe9;tration cutan&#xe9;e rapide facilitant son utilisation dans les soins de&#xa0;la peau. M&#xc9;THODES: Pour d&#xe9;terminer la composition id&#xe9;ale de l'&#xe9;mulsion, une strat&#xe9;gie bas&#xe9;e sur la m&#xe9;thodologie du plan d'exp&#xe9;riences (Design of Experiment, DoE) a &#xe9;t&#xe9; appliqu&#xe9;e en deux &#xe9;tapes: une &#xe9;tape de criblage suivie d'une optimisation. L'&#xe9;tape de criblage visait &#xe0; identifier les principaux ingr&#xe9;dients potentiels et les param&#xe8;tres du proc&#xe9;d&#xe9; ayant un impact significatif sur les propri&#xe9;t&#xe9;s rh&#xe9;ologiques et texturales de l'&#xe9;mulsion. L'&#xe9;tape d'optimisation a permis d'obtenir la formule finale de l'&#xe9;mulsion avec les param&#xe8;tres physico&#x2010;chimiques et les caract&#xe9;ristiques sensorielles souhait&#xe9;s. R&#xc9;SULTATS: Apr&#xe8;s les analyses rh&#xe9;ologiques et sensorielles, le criblage des diff&#xe9;rents ingr&#xe9;dients a r&#xe9;v&#xe9;l&#xe9; que la combinaison de 0,8 % de gomme xanthane comme agent &#xe9;paississant (TA) (glyc&#xe9;ryl st&#xe9;arate citrate (et) polyglyc&#xe9;ryl&#x2010;3 st&#xe9;arate (et) l&#xe9;cithine hydrog&#xe9;n&#xe9;e) comme tensioactif S1, et 1 % d'un m&#xe9;lange d'alcane C15&#x2010;19 (d'origine v&#xe9;g&#xe9;tale et renouvelable) &#x2010; coco&#x2010;caprylate/caprate comme agent sensoriel (SA1) apportait les meilleures qualit&#xe9;s sensorielles &#xe0; l'&#xe9;mulsion. L'&#

Rational QbD-based Assessment of Formulation Ingredients' Impact on Sustainable Sunscreen Physical Stability [PMID: 40739062 · 2025]
Carniel L, Gomes M, Bazzo GC, Ribeiro HM, Marto J, Ramos Pezzini B · AAPS PharmSciTech (2025)

Traditionally, cosmetic emulsions have been developed using trial-and-error approaches, which can be ineffective and time-consuming. This study employed a Quality by Design approach to determine how formulation ingredients impact the physical stability of a sustainable sunscreen. A 2 3 full factorial design assessed the effects of the concentrations of polyglyceryl-2 stearate, glyceryl stearate, stearyl alcohol (self-emulsifier), brassica glycerides (co-emulsifier), and xanthan gum (gelling agent) on the apparent viscosity and instability index of the emulsified vehicle. Another 2 3 full factorial design evaluated the effects of the concentration of zinc oxide, titanium dioxide, and phytic acid on the instability index of the sustainable sunscreen formulation. The instability index of the emulsified vehicle was influenced by self-emulsifier and co-emulsifier concentrations. In contrast, its apparent viscosity was influenced by self-emulsifier and gelling agent concentrations, and by interactions among self-emulsifier, co-emulsifier, and gelling agent. The instability index of the sunscreen formulation was mainly influenced by zinc oxide and phytic acid concentrations. Robust mathematical models were developed and used to predict the optimal compositions of the emulsified vehicle and sunscreen formulation within the experimental domains. The optimal compositions predicted by the mathematical models developed were 8% self-emulsifier, 3% co-emulsifier, and 0.3% gelling agent for the emulsified vehicle, and 6.3% zinc oxide, 2% titanium dioxide, and 1% phytic acid for the sunscreen formulation. These optimized formulations met the Quality Target Product Profiles, ensuring appropriate physical stability, rheological performance, antioxidant properties, and the desired SPF, water resistance, and UVA-PF characteristics.

Preparation and Characterization of Emulsifier-free, Submicron-sized Monodisperse Rice Bran Wax Particles and their Applicability [PMID: 40603073 · 2025]
Ogawa S, Ono M, Sugano S, Nakano T, Niwa K · J Oleo Sci (2025)

The development of an optimal material design is crucial for rice bran wax (RBW) to achieve significant advancements in value-added byproducts. In this study, emulsifier-free, submicron-sized, monodisperse RBW particles were prepared via melt emulsification using a combination of a high-HLB emulsifier-decaglycerin stearate or Tween 20-and a low-HLB emulsifier-glyceryl stearate or Span 20. High dispersibility was achieved due to the zeta-potential generated by the surrounding surfactants, resulting in monodispersed submicron-sized RBW particles. Surface cleaning with ethanol effectively removed surface-adsorbed emulsifiers, yielding emulsion-free RBW particles. Due to the hydrophobic nature of the wax particles, high solvent repellencies were observed, along with the formation of colloidal assemblies such as liquid marbles and W/O Pickering emulsions using cosmetics-applicable liquids. Based on X-ray diffraction analysis and differential scanning calorimetry, RBW was identified as a promising candidate for emulsifier-free submicron-sized particles due to its high crystallinity, which facilitates the effective elimination of emulsifiers.

Falsely elevated triglyceride and lipase levels due to hyperglycerolemia in a burn patient treated with topical silver sulfadiazine [PMID: 39586762 · 2025]
Sriphrapradang C, Srisawasdi P, Shantavasinkul PC, Auparakkitanon S, Krongvorakul J, Punprasit S, Wongdama S · J Clin Lipidol (2025)

Pseudohypertriglyceridemia is an overestimation of serum triglyceride levels, potentially leading to an inaccurate diagnosis of hypertriglyceridemia. This can result from hyperglycerolemia, which interferes with enzymatic measurement methods. Hyperglycerolemia may arise from drugs or genetic glycerol kinase defects. We present a case of a severely burned patient with very high triglyceride levels (up to 5696 mg/dL) that was resistant to lipid-lowering treatment, identified during the work up for pancreatitis associated with elevated lipase levels. Despite the very high triglyceride levels reported in the laboratory results, the standing plasma showed clear plasma, with no significant peak of pre-beta lipoprotein observed on serum lipoprotein electrophoresis. Serum apolipoprotein B levels were low, and urine triglyceride levels were high. This case confirms that very high serum glycerol levels caused the false elevations of triglyceride and lipase levels, resulting from hyperglycerolemia induced by the massive topical application of silver sulfadiazine cream (containing glycerine and glyceryl stearate) to the severely burned wound, which interfered with the laboratory assays. Triglyceride and lipase levels dramatically decreased after reducing the dose of silver sulfadiazine cream. No genetic defects related to glycerol kinase deficiency were identified.

Glyceryl Diesters [PMID: 37751399 · 2023]
Raj PS, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Liebler DC, Rettie AE, Ross D, Slaga TJ, Snyder PW, Tilton S, Fiume M, Heldreth B · Int J Toxicol (2023)

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2002, along with updated information regarding product types and concentrations of use, and confirmed that these 17 glyceryl diesters are safe as cosmetic ingredients in the practices of use and concentration as described in this report.

Development of Artificial-Sebum-Containing Leeming and Notman Agar Medium to Enhance the Growth of Malassezia [PMID: 35610393 · 2022]
Suzuki K, Inoue M, Takayama K, Nagahama T, Cho O, Kurakado S, Sugita T · Mycopathologia (2022)

Modified Leeming and Notman agar medium (mLNA) has been widely utilized to grow lipophilic fungi belonging to the genus Malassezia. We developed a new artificial-sebum-containing mLNA to obtain higher yields of Malassezia species. The olive oil in mLNA was replaced with an artificial sebum composed of triglyceride (triolein), diglyceride (glyceryl distearate), fatty acids (palmitic acid, myristic acid, pentadecanoic acid, and oleic acid), and squalene. Furthermore, the Tween 60 was replaced with self-emulsifying glyceryl stearate. Nine human-associated Malassezia species grew well on the artificial-sebum-containing mLNA, and the most predominant fungus on human skin, Malassezia restricta, exhibited double wet cell weight in artificial sebum-containing mLNA compared to wet cell weight in standard mLNA.

Application of Factorial Design and Rheology to the Development of Photoprotective Formulations [PMID: 31900792 · 2020]
Ferreira VTP, Infante VHP, Felippim EC, Campos PMBGM · AAPS PharmSciTech (2020)

A sunscreen should form a stable and homogeneous film over the skin surface, which can improve its photoprotective activity and avoid adverse effects. For this purpose, the definition of the appropriate vehicle is of fundamental importance since emulsifying agents are known to directly influence the stability, sensorial properties and surface tension of sunscreens, modulating their film-forming performance. In this context, the objective of the present study was to systematically develop formulations with UVB/UVA protection and evaluate the effect of wax concentration on the rheological behaviour. A 2-level full factorial design was applied for the development of four formulations. Two categorical factors were evaluated, glyceryl stearate plus PEG-75 stearate (Wax 1) and methyl glucose sesquistearate (Wax 2). Rheological behaviour was determined in triplicate and rheograms were analysed using the Ostwald model. Rheological parameters were correlated by the Spearman rank correlation test and effects were evaluated by Pareto chart and surface response methodology (SRM). It was possible to identify the pseudoplastic and thixotropic behaviour of all formulations exhibiting a thinning effect on higher shear stress. Factorial analysis showed that both waxes significantly influenced consistency and thixotropic behaviour. The effect of Wax 2 concentration in thixotropy was positive and of higher magnitude and a synergistic effect was also observed. Spearman correlation coefficient of consistency index and apparent viscosity was significantly strong and positive. Finally, factorial analysis allowed the determination of the effects of waxes on the rheological parameters of the formulations. A quantitative relationship between wax concentration and significant responses was established, permitting the prediction of desirable rheological properties for improved sunscreen efficacy.

Formulation and evaluation of a water-in-oil cream containing herbal active ingredients and ferulic acid [PMID: 28559707 · 2017]
Moldovan M, Lahmar A, Bogdan C, P&#x103;r&#x103;uan S, Tomu&#x163;&#x103; I, Cri&#x15f;an M · Clujul Med (2017)

The main aims of the present study were to formulate an anti-age cream based on vegetal ingredients and ferulic acid and to evaluate the physical characteristics and the efficacy of the cream. The active ingredients were Centella asiatica oil, Spilanthes acmella oil, Zingiber officinale extract and ferulic acid. Formulation 1 (F1) was prepared using glyceryl stearate and Ceteareth-25&#xae; as emulsifiers and Formulation 2 (F2) using glyceryl stearate and potassium cetyl phosphate, all other ingredients remaining the same. The physical characterization of the creams was performed and the following parameters were analyzed: viscosity, oil droplet size, polydispersity index; also, texture analysis was performed. The anti-aging effect of the F2 was evaluated by assessing the cutaneous density before and after cream application using DUB-cutis&#xae; scanner. The mean diameter of oil drops was 10.26&#xb1;4.72 mm (F1) and 22.72&#xb1;7.93 mm (F2) and the polydispersity index was 35.4% and 45.7%, respectively. The mean values for consistency were 594.7&#xb1;10.3 g (F1) and 300.5&#xb1;14.5 g (F2), the average values for adhesion were 15.61&#xb1;0.8 mJ (F1) and 22.25&#xb1;4.3 mJ (F2), for firmness were 51.2&#xb1;0.8 g (F1) and 30.3&#xb1;4.3 g (F2) and the spreadability had values between 72.63 mm2 (F1) and 73.3 mm2 (F2). In vivo study revealed that the mean values of the cutaneous density increased from 9.21&#xb1;1.39 % to 12.50&#xb1;1.44 % after 8 weeks of cream application. The herbal ingredients incorporated in the O/W cream base for the antioxidant activity and anti-wrinkle effect, induced changes of the cutaneous density, an important parameter which quantifies the regeneration process of the skin. An anti-age cream containing herbal active ingredients and ferulic acid with appropriate physical characteristics was obtained. In vivo study of clinical efficacy revealed a positive effect on skin density, which increased after 8 weeks of cream application.

Allergenic Ingredients in Facial Wet Wipes [PMID: 28338538 · 2017]
Aschenbeck KA, Warshaw EM · Dermatitis (2017)

Allergic contact dermatitis commonly occurs on the face. Facial cleansing wipes may be an underrecognized source of allergens. The aim of this study was to determine the frequency of potentially allergenic ingredients in facial wet wipes. Ingredient lists from name brand and generic facial wipes from 4 large retailers were analyzed. In the 178 facial wipes examined, a total of 485 ingredients were identified (average, 16.7 ingredients per wipe). Excluding botanicals, the top 15 potentially allergenic ingredients were glycerin (64.0%), fragrance (63.5%), phenoxyethanol (53.9%), citric acid (51.1%), disodium EDTA (44.4%), sorbic acid derivatives (39.3%), tocopherol derivatives (38.8%), polyethylene glycol derivatives (32.6%), glyceryl stearate (31.5%), sodium citrate (29.8%), glucosides (27.5%), cetearyl alcohol (25.8%), propylene glycol (25.3%), sodium benzoate (24.2%), and ceteareth-20 (23.6%)/parabens (23.6%). Of note, methylisothiazolinone (2.2%) and methylchloroisothiazolinone (1.1%) were uncommon. The top potential allergens of botanical origin included Aloe barbadensis (41.0%), chamomile extracts (27.0%), tea extracts (21.3%), Cucumis sativus (20.2%), and Hamamelis virginiana (10.7%). Many potential allergens are present in facial wet wipes, including fragrances, preservatives, botanicals, glucosides, and propylene glycol.

Ultra-micro Liquid Crystal in Cosmetic Emulsion with Excellent Moisture Retention and Delivery Selectivity [PMID: 39619544 · 2024]
Hua Z, Zhang C, He J, Chen Y, Zhang S, Sun J, Wang N, Zhang J, Yang X, Chen J, Wei X · ACS Omega (2024)

Compared with ordinary emulsified cosmetics, liquid crystal emulsified cosmetics have obvious advantages. In this paper, an ultra-micro liquid crystal (ULC) emulsion with particle size less than 4 &#x3bc;m was successfully synthesized using a simple oil-in-water emulsification method, and large liquid crystal (LLC) and non-liquid crystal (NLC) emulsions were also prepared as controls. Three kinds of emulsions were examined by polarizing microscopy, X-ray diffraction (XRD), small-angle X-ray scattering (SAXS) and cryo-transmission electron microscopy (cryo-TEM). Rheological tests, in vivo experiments, reconstructed Raman maps tracking selected markers and thermogravimetric (TG) results showed that the ULC emulsion expressed excellent viscoelasticity, long-term moisturizing property with barrier function and better selective delivery of active substances compared with LLC and NLC emulsions. Molecular dynamics simulation on the ULC system and deuterium order parameter plots respectively indicated that GYY (glyceryl stearate citrate) showed a tendency to form a stable structure by reducing the total interaction energy and enhancing system lamellar ordering. This work not only demonstrates the great potential of ultra-micro liquid crystals in for commercial applications in cosmetics but also offers a deeper understanding of the intrinsic properties and growth mechanisms of ultra-micro liquid crystals at the microscopic level.

Double Hydrophilic Hyperbranched Copolymer-Based Lipomer Nanoparticles: Copolymer Synthesis and Co-Assembly Studies [PMID: 39599220 · 2024]
Gerardos AM, Pispas S · Polymers (Basel) (2024)

Double hydrophilic, random, hyperbranched copolymers were synthesized via reversible addition-fragmentation chain transfer (RAFT) polymerization of oligo(ethylene glycol) methyl ether methacrylate (OEGMA) and 2-(dimethylamino)ethyl methacrylate (DMAEMA) utilizing ethylene glycol dimethacrylate (EGDMA) as the branching agent. The resulting copolymers were characterized in terms of their molecular weight and dispersity using size exclusion chromatography (SEC), and their chemical structure was confirmed using FT-IR and 1 H-NMR spectroscopy techniques. The choice of the two hydrophilic blocks and the design of the macromolecular structure allowed the formation of self-assembled nanoparticles, partially due to the pH-responsive character of the DMAEMA segments and their interaction with -COOH end groups remaining from the chain transfer agent. The copolymers showed pH-responsive properties, mainly due to the protonation-deprotonation equilibria of the DMAEMA segments. Subsequently, a nanoscopic polymer-lipid (lipomer) mixed system was formulated by complexing the synthesized copolymers with cosmetic amphiphilic emulsifiers, specifically glyceryl stearate (GS) and glyceryl stearate citrate (GSC). This study aims to show that developing lipid-polymer hybrid nanoparticles can effectively address the limitations of both liposomes and polymeric nanoparticles. The effects of varying the ionic strength and pH on stimuli-sensitive polymeric and mixed polymer-lipid nanostructures were thoroughly investigated. To achieve this, the structural properties of the hybrid nanoparticles were comprehensively characterized using physicochemical techniques providing insights into their size distribution and stability.

Preparation and characterization of glyceryl stearate/cassava starch composite for wax therapy [PMID: 38272417 · 2024]
Punyanitya S, Thiansem S, Raksanti A, Chankachang P, Koonawoot R · Int J Biol Macromol (2024)

Glyceryl stearate and cassava starch (CS) composites were prepared by an esterification process. Formulations containing starch at various concentrations were prepared, being 1, 1.5, 3, 5, 10, 15, 20, and 30&#xa0;% by weight, respectively. The characteristics of pH, moisture content, FTIR, melting point, latent heat, thermal energy storage, and specific heat capacity of composites were elucidated. The optimal formulation contained 1&#xa0;% w/w CS, this indicated that the composite was able to maintain its temperature for 9.4&#xa0;&#xb1;&#xa0;0.5&#xa0;min, with a melting temperature of 51.9&#xa0;&#xb1;&#xa0;0.3&#xa0;&#xb0;C, solidification temperature of 36.1&#xa0;&#xb1;&#xa0;1.6&#xa0;&#xb0;C, latent heat of fusion of 120&#xa0;&#xb1;&#xa0;10&#xa0;J/g, and latent heat of solidification of 126&#xa0;&#xb1;&#xa0;3&#xa0;J/g, and specific heat capacity of 2.6&#xa0;&#xb1;&#xa0;0.2&#xa0;J/g.K. New bonds were formed in the composite structure of glyceryl stearate and CS at these levels. The composite had a pH that was safe for contact with human skin and a moisture content that could be kept stable for a prolonged time. The innovation and the advantages of a composite materials: 1. The main components are derived from natural materials. 2. Costs effective 3. Sustainability 4. Safety, and 5. Efficacy. Therefore, composites have a high potential as are replacement for paraffin wax bath therapy.

常见问题解答 (FAQ)

Q1. 甘油硬脂酸酯 (GLYCERYL STEARATE) 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 '甘油硬脂酸酯',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'GLYCERYL STEARATE',日本 JCIA 表示名称为 'ステアリン酸グリセリル'。
Q2. 甘油硬脂酸酯 (GLYCERYL STEARATE) 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. 甘油硬脂酸酯 (GLYCERYL STEARATE) 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 0.5%–5%(中位数 2%),最佳稳定 pH 范围为 4–9。
Q4. 甘油硬脂酸酯 (GLYCERYL STEARATE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
推荐协同组合包括 PEG-100 STEARATE, CETEARYL ALCOHOL, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE;配伍禁忌注意:Do not confuse pure non-ionic Glyceryl Stearate (HLB ~3.8) with Glyceryl Stearate SE (contains potassium/sodium stearate soap; breaks at pH < 6.8)。