原料词典检索/isopropyl-myristate/ISOPROPYL MYRISTATE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
化学合成 (Synthetic)

ISOPROPYL MYRISTATE

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 肉豆蔻酸异丙酯 (序号 #5608)
香精 / 香料粘合剂柔润剂
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 肉豆蔻酸异丙酯 (ISOPROPYL MYRISTATE) 的全球法规限值与配方应用标准是什么?

肉豆蔻酸异丙酯(标准 INCI: ISOPROPYL MYRISTATE,CAS 号: 110-27-0)是化妆品配方中主要用作香精 / 香料, 粘合剂, 柔润剂的核心成分。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 0.8–18%(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
7-Track Official Statutory Label Names for ISOPROPYL MYRISTATE
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)ISOPROPYL MYRISTATE (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)ISOPROPYL MYRISTATE
④ 美国普通化妆品 (US PCPC / MoCRA INCI)ISOPROPYL MYRISTATE
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)肉豆蔻酸异丙酯
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)ISOPROPYL MYRISTATE (标准 INCI 参照)

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 ISOPROPYL MYRISTATE
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 #5608
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

Emulsion / Creamn=14
Min 0.8% · Q1 1.625% · Median 6.15% · Q3 6.5% · Max 18%
Sunscreen / Colorn=10
Min 1.5% · Q1 2.25% · Median 3.55% · Q3 8.5% · Max 10%
Emulsion / Cream — Emulsion cream & lotion structural / conditioning agent
Verified Source: Global Starter Formulation Library Statistical Distribution (n=14, EVONIK 12 · SEPPIC 2) (cir_safety) · EVONIK 12 · SEPPIC 2
Typical Median: 6.15%

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 ISOPROPYL MYRISTATE
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)0.8% · 1.625% · 6.15% · 6.5% · 18%Emulsion cream & lotion structural / conditioning agentGlobal Starter Formulation Library Statistical Distribution (n=14, EVONIK 12 · SEPPIC 2)
剂型组 D — 防晒霜 / 彩妆 / 粉底1.5% · 2.25% · 3.55% · 8.5% · 10%Sun care & color cosmetics dispersion / sensory modifierGlobal Starter Formulation Library Statistical Distribution (n=10, ELEMENTIS 7 · EVONIK 3)
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

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 (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

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

Water or glycol phase soluble/dispersible
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
0245.5791114

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C
25°C45°C60°C75°C85°C100°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
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
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)

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ Verify phase compati…ISOPROPYL MYRISTATE
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)
ISOPROPYL MYRISTATE

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: ISOPROPYL MYRISTATE | CAS No.: 110-27-0 | EC No.: 203-751-4 - Origin: SYNTHETIC | Functions: , , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [ISOPROPYL MYRISTATE] · EU [ISOPROPYL MYRISTATE] · CN [肉豆蔻酸异丙酯] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - ISOPROPYL MYRISTATE functions primarily as , , in dermatological and cosmetic formulations. 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. 5608 (肉豆蔻酸异丙酯)) - 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): Quantum satis (QS) within standard cosmetic safety margins ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [emulsion_cream] Typical range: 0.8 ~ 18.0% (Median 6.15%, Ref: Global Starter Formulation Library Statistical Distribution (n=14, EVONIK 12 · SEPPIC 2)) — Emulsion cream & lotion structural / conditioning agent - [sun_color] Typical range: 1.5 ~ 10.0% (Median 3.55%, Ref: Global Starter Formulation Library Statistical Distribution (n=10, ELEMENTIS 7 · EVONIK 3)) — 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: ISOPROPYL MYRISTATE ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 35127174 (2022, J Adv Res): Skin cancer biology and barriers to treatment: Recent applications of polymeric micro/nanostructures. - PMID 31652587 (2019, Pharmaceutics): Preparation, Characterisation, and Topical Delivery of Terbinafine. - PMID 28976900 (2017, Folia Med (Plovdiv)): Nuts and Bolts of Oil and Temperature in Topical Preparations of Salicylic Acid.

关联同行评审文献 (NIH PubMed) (3)

Skin cancer biology and barriers to treatment: Recent applications of polymeric micro/nanostructures. [PMID: 35127174 · 2022]
Khan NH, Mir M, Qian L, Baloch M, Ali Khan MF, Rehman AU, Ngowi EE, Wu DD, Ji XY · J Adv Res (2022)

Skin cancer has been the leading type of cancer worldwide. Melanoma and non-melanoma skin cancers are now the most common types of skin cancer that have been reached to epidemic proportion. Based on the rapid prevalence of skin cancers, and lack of efficient drug delivery systems, it is essential to surge the possible ways to prevent or cure the disease. Although surgical modalities and therapies have been made great progress in recent years, however, there is still an urgent need to alleviate its increased burden. Hence, understanding the precise pathophysiological signaling mechanisms and all other factors of such skin insults will be beneficial for the development of more efficient therapies. In this review, we explained new understandings about onset and development of skin cancer and described its management via polymeric micro/nano carriers-based therapies, highlighting the current key bottlenecks and future prospective in this field. In therapeutic drug/gene delivery approaches, polymeric carriers-based system is the most promising strategy. This review discusses that how polymers have successfully been exploited for development of micro/nanosized systems for efficient delivery of anticancer genes and drugs overcoming all the barriers and limitations associated with available conventional therapies. In addition to drug/gene delivery, intelligent polymeric nanocarriers platforms have also been established for combination anticancer therapies including photodynamic and photothermal, and for theranostic applications. This portfolio of latest approaches could promote the blooming growth of research and their clinical availability.

Preparation, Characterisation, and Topical Delivery of Terbinafine. [PMID: 31652587 · 2019]
Hossain ASMMA, Sil BC, Iliopoulos F, Lever R, Hadgraft J, Lane ME · Pharmaceutics (2019)

Terbinafine (TBF) is commonly used in the management of fungal infections of the skin because of its broad spectrum of activity. Currently, formulations containing the free base and salt form are available. However, there is only limited information in the literature about the physicochemical properties of this drug and its uptake by the skin. In this work, we conducted a comprehensive characterisation of TBF, and we also examined its percutaneous absorption in vitro in porcine skin. TBF-free base was synthesised from the hydrochloride salt by a simple proton displacement reaction. Both the free base and salt form were further analysed using Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA). Delivery of TBF-free base in excised porcine skin was investigated from the following solvents: Isopropyl myristate (IPM), propylene glycol monolaurate (PGML), Transcutol &#xae; (TC), propylene glycol (PG), polyethylene glycol 200 (PEG 200), oleic acid (OL), ethanol (EtOH), and isopropyl alcohol (IPA). Permeation and mass balance studies confirmed that PG and TC were the most efficacious vehicles, delivering higher amounts of TBF-free base to the skin compared with a commercial gel ( p &lt; 0.05). These preliminary results are promising and will inform the development of more complex formulations in future work.

Nuts and Bolts of Oil and Temperature in Topical Preparations of Salicylic Acid. [PMID: 28976900 · 2017]
Ashara KC, Shah KV · Folia Med (Plovdiv) (2017)

Traditional formulations of salicylic acid in ointment bases have disadvantages of being greasy and irritant due to free crystals. To explore the method for selection of oils and their ratio for topical preparation on the basis of equilibrium solubility study of salicylic acid and to evaluate temperature effect. Scanning and calibration curve of salicylic acid in methanol were developed. Among available oils, those that had no interference of absorbance of salicylic acid were short-listed for screening purpose. Selections of oils were carried out on the basis of equilibrium solubility study. Compatibility study was made by Fourier Transform Infra-Red spectroscopy analysis. Primitive study of oil mixtures was done. Selections of the ratio of oils were carried out on basis of constrained simplex-centroid design. Salicylic acid had shown linearity in the range of 15-65 &#x3bc;g/mL in methanol at wavelength maximum (300 nm). From the equilibrium solubility study, Parker Neem&#xae; Oil (11.81 &#xb1; 0.5 mg/g), Isopropyl Myristate (11.29 &#xb1; 0.04 mg/g), Mogra Oil (9.62 &#xb1; 0.94 mg/g) were selected. The study possessed the same main Fourier transform infra-red peaks of salicylic acid in the salicylic acid-oils physical mixture. 58.64% Parker Neem&#xae; oil and 41.36% isopropyl myristate mixture was selected as optimized batch with the desirability of 0.391. The oils mixture could be selected for topical preparation of salicylic acid like paste, cream, ointment etc.

常见问题解答 (FAQ)

Q1. 肉豆蔻酸异丙酯 (ISOPROPYL MYRISTATE) 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 '肉豆蔻酸异丙酯',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ISOPROPYL MYRISTATE',日本 JCIA 表示名称为 'ISOPROPYL MYRISTATE'。
Q2. 肉豆蔻酸异丙酯 (ISOPROPYL MYRISTATE) 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. 肉豆蔻酸异丙酯 (ISOPROPYL MYRISTATE) 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 0.8%–18%(中位数 6.15%),最佳稳定 pH 范围为 4–8。
Q4. 肉豆蔻酸异丙酯 (ISOPROPYL MYRISTATE) 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。