CAPRYLOYL GLYCINE
化妆品中 辛酰甘氨酸 (CAPRYLOYL GLYCINE) 的全球法规限值与配方应用标准是什么?
辛酰甘氨酸(标准 INCI: CAPRYLOYL GLYCINE,CAS 号: 14246-53-8)是化妆品配方中主要用作控油剂, 抗菌剂, 除臭剂的核心成分。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 0.8–5%(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) | CAPRYLOYL GLYCINE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | CAPRYLOYL GLYCINE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | CAPRYLOYL GLYCINE | |
| 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) | 辛酰甘氨酸 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | CAPRYLOYL GLYCINE (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 #7215 |
| 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 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) | 0.8% · 3% · 5% · 5% · 5% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 7) |
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 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°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) (4)
Capryloyl glycine and soy isoflavonoids in hypertrichosis: An experimental and placebo-controlled clinical study. [PMID: 33934471 · 2021]
The management of acquired hypertrichosis (HT) is based on the search of the causes and subsequent specific treatment. However, simultaneous hair removal is important. No single method for hair removal is appropriate for all patients and skin areas. Treatment options are actually limited and clinical results are often unsatisfactory. Ornithine decarboxylase 1 (ODC1), an enzyme present in hair follicles, is considered as a potential target to inhibit hair growth. Only eflornithine hydrochloride, an inhibitor of ODC1, showed to be partially effective in the management of acquired HT. The aim of our study was to evaluate the potential inhibition of ODC1 activity by a cream containing 4% capryloyl glycine, an ODC1 inhibitor, and 1% glycine soy-fermented extract (soy isoflavonoids). Furthermore, we present the results of a placebo-controlled clinical study that evaluated the efficacy and tolerability of this cream. The ODC1 activity was detected by measuring absorbance at 340 nm. In the presence of ODC1 inhibitors, absorbance decreases as a function of inhibition. Difluoromethylornithine (DFMO) was provided as an inhibitor control. ODC1 activity inhibition was expressed as percentage of control (untreated sample). All data were presented as mean ± standard deviation of three independent experiments. To determine if statistically significant differences between treatments were present, a t test analysis was performed. The differences between groups were considered significant at p < 0.05. Twelve Caucasian female adult patients, with HT located on the forearms, were enrolled. The study cream (product A) was applied twice/day for four months on the right forearm. A placebo cream (product B) was applied twice/day for four months on the left forearm. Clinical efficacy was evaluated by means of macrophotography. The cream significantly inhibited ODC1 activity (35.1 ± 0.5% inhibition, equivalent to a 64.9 ± 0.5% ODC1 activity). DFMO completely abolished the enzymatic activity (100 ± 5% inhibition, equivalent to 0 ± 5% ODC1 activity). All patients were considered evaluable. In 11 out of 12 patients (91.7%), who were treated with product A, an improvement was observed. No improvement was observed in patients treated with product B. The global assessment showed good efficacy in 7 patients (58.3%) and moderate efficacy in 5 patients (41.7%) treated with the product A. No efficacy was detected in patients treated with product B. The study cream showed to be effective in Caucasian, adult, female patients with hypertrichosis located on the forearms.
Capryloyl glycine: A polyfunctional cosmetic ingredient and potential skin sensitizer. [PMID: 30652324 · 2019]
Assessment of the skin efficacy and acceptability of a cosmetic product in the treatment of the forearm hypertrichosis in female patients. [PMID: 33347705 · 2021]
Treatment of unwanted body hair is a challenging area in cosmetic dermatology. Topical soy isoflavones and derivatives or eflornithine have been utilized in dermatocosmetology for their estrogenic and antiandrogenic activity. To evaluate the efficacy of a formulation containing capryloyl glycine 4% in decreasing hair growth on the forearms after topical application for 120 days vs placebo. A total of 69 female patients entered the study (age 37 ± 6). Hair growth was quantified using TrichoScan software on both forearms at 20-fold magnification (analyzed area 0.651 cm2). Hair density (number of hairs/cm 2 ), density vellus hair, density terminal hair, and median length of hairs were evaluated. The data were analyzed using ANOVA for repeated measures to evaluate changes during the treatment (T0, T60, and T120) and Student's t test (placebo vs active). There was a significant decrease on hair density, median, and terminal hair at the end of the treatment in the active-treated site (P < .001) as measured by TrichoScan software. Direct comparison between active and placebo-treated sites showed no significant differences at T0, but highly significant differences at T120 (P < .001). The study shows that a cosmetic formulation based on capryloyl glycine 4% is highly effective in reducing several parameters related to hair growth and hair thickness vs placebo, thus showing efficacy in the treatment of hypertrichosis.
Allergic contact dermatitis caused by capryloyl glycine in an atopic dermatitis patient. [PMID: 35460572 · 2022]
常见问题解答 (FAQ)
- Q1. 辛酰甘氨酸 (CAPRYLOYL GLYCINE) 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 '辛酰甘氨酸',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'CAPRYLOYL GLYCINE',日本 JCIA 表示名称为 'CAPRYLOYL GLYCINE'。
- Q2. 辛酰甘氨酸 (CAPRYLOYL GLYCINE) 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. 辛酰甘氨酸 (CAPRYLOYL GLYCINE) 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%–5%(中位数 5%),最佳稳定 pH 范围为 4–8。
- Q4. 辛酰甘氨酸 (CAPRYLOYL GLYCINE) 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。