GUAIAZULENE
化粧品における GUAIAZULENE のグローバル配合基準と処方特性とは?
GUAIAZULENE(CAS番号: 489-84-9)は、化粧品処方において主に抗菌剤, 香料として配合される原料です。日本厚労省/JCIA(規制なし)、韓国MFDS(配合可能)、欧州CosIng(規制なし)など6大法域の法定基準下で管理され、通常 0.1–5.0%(適正安定域 pH 4.5–7.5)で処方されます。
7大トラック 国別・用途別 公式全成分表示名称マトリクス
各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ| 法域・規制トラック | 公式全成分表示名称 | ワンクリックコピー |
|---|---|---|
| ① 韓国 (MFDS 化粧品標準名称) | GUAIAZULENE (KR MFDS Registered) | |
| ② 韓国旧名称履歴 (301 リダイレクト) | — | — |
| ③ 欧州連合 (EU CosIng EC 1223/2009) | GUAIAZULENE | |
| ④ 米国一般化粧品 (US PCPC / MoCRA INCI) | GUAIAZULENE | |
| ⑤ 米国 FDA OTC モノグラフ有効成分名 | — (米国 OTC 対象外 / 一般化粧品原料) | — |
| ⑥ 中国 (NMPA IECIC 標準中国語名称) | 愈创薁 | |
| ⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW) | GUAIAZULENE (標準INCI参照 · 任意カタカナ音訳排除) |
Layer 1 — 6大法域 法定配合上限および規制ステータス
| 法域 | 規制ステータス | 配合上限 | 制限条件および一次法源出典 |
|---|---|---|---|
| 米国 (FDA) | 配合制限 | — | [US RESTRICTED] * Eye Area : No
* 눈 주위 : 사용금지
* Generally (Includes Lipsticks) : No
* 일반적인 사용 (립스틱 포함) : 사용금지
* External Use : Yes
* 외용 : 사용가능 Source: API () |
| ASEAN (ACD) | 配合制限 | — | [ASEAN RESTRICTED] * 단서조항(주석) : (3) Adopted during the Fifth ASEAN Cosmetic Committee Meeting
(3) 제5회 아세안 화장품 위원회에서 채택됨
* Field of application : Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of eyes, in particular eye make-up and eye make-up remover.
* 적용 범위 : 아이 메이크업이나 아이 메이크업 리무버에 사용되는 것을 제외한 모든 제품에서 허용된 착색제 Source: API () |
| 韓国 (MFDS) | 配合可能 | — | Permitted within statutory scope Source: [1] (3 ) |
Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)
「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。
| 安全性評価基準 | 適用範囲・用途 | 安全濃度範囲 | 判定結果および文献参照 |
|---|---|---|---|
| 中国 IECIC 最高歴史使用量 | leave_on | ≤ 0.2% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 08112 (2025) |
| 中国 IECIC 最高歴史使用量 | rinse_off | ≤ 0.1% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 08112 (2025) |
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 4.5–7.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 70°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
学術・毒性・処方統合モノグラフ
Tier 2 Synthesis本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。
関連査読付き学術論文 (NIH PubMed) (4)
Guaiazulene and related compounds: A review of current perspective on biomedical applications. [PMID: 36646376 · 2023]
Thousands of people worldwide pass away yearly due to neurological disorders, cardiovascular illnesses, cancer, metabolic disorders, and microbial infections. Additionally, a sizable population has also been impacted by hepatotoxicity, ulcers, gastroesophageal reflux disease, and breast fissure. These ailments are likewise steadily increasing along with the increase in life expectancy. Finding innovative therapies to cure and consequently lessen the impact of these ailments is, therefore, a global concern. All provided literature on Guaiazulene (GA) and its related compounds were searched using various electronic databases such as PubMed, Google Scholar, Web of Science, Elsevier, Springer, ACS, CNKI, and books via the keywords Guaiazulene, Matricaria chamomilla, GA-related compounds, and Guaiazulene analogous. The FDA has approved the bicyclic sesquiterpene GA, commonly referred to as azulon or 1,4-dimethyl-7-isopropylazulene, as a component in cosmetic colorants. The pleiotropic health advantages of GA and related substances, especially their antioxidant and anti-inflammatory effects, attracted a lot of research. Numerous studies have found that GA can help to manage various conditions, including bacterial infections, tumors, immunomodulation, expectorants, diuretics, diaphoresis, ulcers, dermatitis, proliferation, and gastritis. These conditions all involve lipid peroxidation and inflammatory response. In this review, we have covered the biomedical applications of GA. Moreover, we also emphasize the therapeutic potential of guaiazulene derivatives in pre-clinical and clinical settings, along with their underlying mechanism(s). GA and its related compounds exhibit therapeutic potential in several diseases. Still, it is necessary to investigate their potential in animal models for various other ailments and establish their safety profile. They might be a good candidate to advance to clinical trials.
Efficacy and feasibility analysis of compound fluocinolone acetonide cream combined with guaiazulene in the treatment of neurodermatitis. [PMID: 39162834 · 2024]
To evaluate the effectiveness and feasibility of combined treatment with compound fluocinolone acetonide cream and guaiazulene in patients with neurodermatitis. A prospective study was conducted on 92 outpatient patients diagnosed with neurodermatitis at our dermatology department from January 2022 to December 2023. Using a random number table, these patients were evenly divided into a control group and an experimental group, with 46 individuals in each group. The control group received treatment with compound fluocinolone acetonide alone, while the experimental group additionally received oral guaiazulene tablets. Clinical symptom and sign scores, Visual Analog Scale (VAS) scores, skin lesion itching scores, comprehensive efficacy, treatment onset time, adverse reactions, and quality of life were monitored, recorded, and compared. In the 2-week treatment period, patients in the experimental group showed significant improvement in skin symptoms and signs, with scores significantly lower than those in the control group (P < 0.05). After treatment, VAS and skin lesion itching scores in the experimental group were significantly reduced (P < 0.05), demonstrating a more pronounced therapeutic advantage compared to the control group (P < 0.05). Although the effective rate in the experimental group was as high as 86.96%, there was no significant advantage compared to the control group, and the difference in treatment efficacy was not significant (P > 0.05). The treatment onset time in the experimental group was significantly shorter than that in the control group (P < 0.05), and the incidence of adverse reactions was lower (P < 0.05). The quality of life in the experimental group improved significantly after treatment, with DLQI scores lower than those in the control group (P < 0.05). Combined treatment with compound fluocinolone acetonide cream and guaiazulene demonstrates excellent efficacy and feasibility in the management of neurodermatitis. Compared to standard treatment alone, it yields superior clinical outcomes.
Guaiazulene Triggers ROS-Induced Apoptosis and Protective Autophagy in Non-small Cell Lung Cancer. [PMID: 33935713 · 2021]
Non-small cell lung cancer (NSCLC) is one of the most frequent cancers worldwide, yet effective treatment remains a clinical challenge. Guaiazulene (GYZ), a cosmetic color additive, has previously been characterized as a potential antitumor agent due to observed anticancer effects. However, the efficacy of GYZ in the treatment of NSCLC and the involved molecular mechanisms remain largely unknown. Here, we indicated a role for GYZ in the suppression of NSCLC both in vitro and in vivo via triggering reactive oxygen species (ROS)-induced apoptosis . Concomitantly, GYZ induced complete autophagic flux in NSCLC cells via inhibiting the Akt/mTOR signaling pathway, which displayed cytoprotective effect against GYZ-induced growth suppression. Accompanied with autophagy inhibition obviously enhanced the effects of GYZ. Notably, GYZ acts synergistically with paclitaxel in the suppression of NSCLC in vitro . Together, our results for the first time reported that GYZ suppressed the proliferation of NSCLC and suggested a potential strategy for inhibiting NSCLC growth by combinational use of GYZ and autophagy inhibitors.
Avobenzone, Guaiazulene and Tioxolone identified as potent autophagy inducers in a high-throughput image based screen for autophagy flux. [PMID: 40396033 · 2022]
Autophagy is a conserved intracellular degradation pathway that is essential for maintaining cellular homeostasis. Given its critical role in several disease conditions, recent studies are focussed on identifying drugs/small molecules with autophagy modulating capacity for potential clinical applications. Here, we describe the development and characterisation of a quantitative image-based high content screening platform for autophagy flux measurements using the human melanoma A375 cell line that stably expresses the GFP-LC3-RFP probe. The GFP-LC3 is incorporated into autophagosomes, while RFP serves an internal control. The GFP/RFP fluorescence intensity ratio gives an accurate indication of autophagy induction (low ratio) vs blockage of autophagy flux (high ratio), and was validated with the autophagy inducer Torin1 and inhibitor Bafilomycin A 1 . This assay was used to screen the Spectrum collection library comprising of 2560 compounds, to identify autophagy modulators. In addition to known autophagy effectors, several novel autophagy inducers and inhibitors were identified in our study. Further three FDA approved drugs that are widely used in skin-care products: Avobenzone, Guaiazulene and Tioxolone, were validated as potent autophagy inducers that function in an mTOR independent manner. Baf, Bafilomycin A 1 ; LC3, Microtubule-associated protein light chain 3; mTOR, mechanistic target of rapamycin.
よくある質問 (FAQ)
- Q1. GUAIAZULENE の各国公式全成分表示名称(7トラック)はどのように異なりますか?
- 日本化粧品工業連合会(JCIA)表示名称は 'GUAIAZULENE (標準INCI準拠)'、米国PCPC・欧州CosIng INCIは 'GUAIAZULENE'、中国NMPA IECIC標準中国語名は '愈创薁' です。
- Q2. GUAIAZULENE のグローバル6大法域における法定配合基準 (Layer 1) は?
- 6大法域規制ステータス — 日本(JP): none、韓国(KR): allowed、欧州(EU): none、米国(US): restricted、中国(CN): allowed、ASEAN: restricted。
- Q3. 処方設計における GUAIAZULENE の通常配合濃度 (Layer 3) と適正 pH は?
- 適正pH 4.5〜7.5、工程上限温度 ≤70°C の範囲で安定に処方されます。
- Q4. GUAIAZULENE の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
- 推奨シナジーペアは Panthenol, Ceramide NP, Hydrolyzed Sponge、配合上の注意点は Avoid extreme pH or strong oxidizing agents です。