원료 사전 탐색/alpha-arbutin/ALPHA-ARBUTIN
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
합성 (Synthetic)

ALPHA-ARBUTIN

식약처 한글 표준명: 알파-알부틴
항산화제미백제탈색제피부컨디셔닝제
[식약처 공정서 기원 및 정의] 이 원료는 다음의 구조를 갖는 유기화합물이다.
[EU CosIng Official Definition] Alpha-Arbutin is the organic compound that conforms to the formula:
결론 선행 Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

화장품에서 알파-알부틴 (ALPHA-ARBUTIN)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?

알파-알부틴(표준 INCI: ALPHA-ARBUTIN, CAS 번호: 84380-01-8)은 화장품 처방에서 주로 항산화제, 미백제, 탈색제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(표시·고시) 및 유럽 CosIng(제한) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.2–2%(적정 pH 4.5–6) 범위에서 안정적으로 처방됩니다.

7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스

각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건
7-Track Official Statutory Label Names for ALPHA-ARBUTIN
국가·규제 트랙공식 고시 전성분 표기명원클릭 복사
① 한국 (MFDS 화장품 한글 표준명)알파-알부틴
② 한국 구명칭 (개정 전 이력 · 301 리다이렉트)——
③ 유럽 (EU CosIng EC 1223/2009)ALPHA-ARBUTIN
④ 미국 일반화장품 (US PCPC / MoCRA INCI)ALPHA-ARBUTIN
⑤ 미국 OTC (FDA Active Ingredient Monograph)— (비-OTC 일반 화장품 원료)—
⑥ 중국 (NMPA IECIC 표준 중문명)α-熊果苷
⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW)α-アルブチン · [QD: α-アルブチン]

Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태

Layer 1 Statutory Regulatory Limits Across 6 Regions for ALPHA-ARBUTIN
권역규제 상태배합 한도제한 조건 및 1차 법원 출처
한국 (MFDS)표시·고시GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
유럽 (CosIng)제한GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
미국 (FDA/CIR)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
중국 (NMPA)표시·고시GMPIECIC Entry #1005
일본 (MHLW)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
아세안 (ACD)제한GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)

Layer 2 — 독성·안전성 평가 한도 (US CIR · EU SCCS MoS≥100 · CN IECIC 최고역사사용량)

「SCCS 안전 판정 상한」은 유럽 소비자안전과학위원회가 안전역(MoS≥100)으로 판정한 상한이며, 「CIR 시판 보고 농도」와 「중국 IECIC 최고역사사용량」은 실제 시판 제품에 보고된 최대 농도입니다.

Layer 2 Toxicological & Historical Safe Use Concentrations for ALPHA-ARBUTIN
안전성 평가 기준적용 부위·유형안전 농도 범위판정 결과 및 문헌 번호
EU SCCS 안전 판정 상한face_cream≤ 2%안전 판정(MoS≥100) ()
EU SCCS 안전 판정 상한face_cream≤ 2%안전 판정(MoS≥100) ()
EU SCCS 안전 판정 상한body_lotion≤ 0.5%안전 판정(MoS≥100) ()
중국 IECIC 최고역사사용량leave_on≤ 2%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 00048 (2025)
중국 IECIC 최고역사사용량rinse_off≤ 2%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 00048 (2025)
⚠️ 참조용 안내 (법적 면책 공지): 이 사전의 성분명·규제 한도·배합 가이드는 연구·개발 참조용으로만 제공됩니다. 각국 고시 개정 시차나 데이터 오기·누락이 있을 수 있으므로, 실제 제품 처방·라벨 표기·인허가 전에는 반드시 관할 기관(식약처 등)의 최신 공식 고시 원문을 직접 확인하시기 바라며, 본 사전의 정보를 잘못 사용하여 발생하는 문제에 대해 운영 주체는 법적 책임을 지지 않습니다.
제형군별 사분위수(Min–Q1–Median–Q3–Max) 분포 그래프

Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조

수성 토너·세럼·앰플n=48
Min 0.2% · Q1 0.5% · Median 1% · Q3 2% · Max 2%
O/W · W/O 에멀전·크림n=56
Min 0.2% · Q1 0.5% · Median 1% · Q3 2% · Max 2%
수성 토너·세럼·앰플 — 멜라닌 합성 효소 티로시나아제(Tyrosinase) 경쟁적 가역 저해 (EU 안면 한도 2.0%)
공식 검증 원천: EU SCCS/1642/22 Final Opinion & EU Omnibus 2024/996 (sccs) · DSM · Bioland · Global Derma
권장 중앙값: 1%

Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드

Layer 3 Formulation Concentration Quartiles by Product Category for ALPHA-ARBUTIN
제형군 분류Min – Q1 – Median – Q3 – Max (%)처방 역할 및 기전Source ID
제형군 A — 수성 토너 · 세럼 · 고농축 앰플0.2% · 0.5% · 1% · 2% · 2%멜라닌 합성 효소 티로시나아제(Tyrosinase) 경쟁적 가역 저해 (EU 안면 한도 2.0%)EU SCCS/1642/22 Final Opinion & EU Omnibus 2024/996
제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O)0.2% · 0.5% · 1% · 2% · 2%브라이트닝 크림 (페이스 최대 2.0%, 바디로션 최대 0.5% EU 법정 한도)EU Regulation 2024/996 Annex III & SCCS/1642/22
피부 투과 과학 시각화 (Bos & Meinardi 500 Dalton Rule)MW: 272.25 Da · LogP: -1.35

각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션

각질층 (Stratum Corneum · 10~20 µm)500 Dalton 장벽 (고분자·친수성 성분 차단)생존 표피층 (Viable Epidermis · 50~100 µm)멜라닌세포 · 각질형성세포 타깃 (미백·장벽·턴오버)진피 유두층 (Papillary Dermis · 150~300 µm)섬유아세포 콜라겐 I/III · 엘라스틴 · PDRN 재생 타깃표피~상부 진피 확산 (<500 Da)
분자량(MW) & 친유성(LogP) 투과 판정
저분자 영역 (272.25 Da ≤ 500 Da) — 각질층 수동 확산 가능

단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.

예상 도달 깊이
40–90 µm
권장 전달 시스템
Polyol Enhancer / Serum
계면화학 · pH · 열역학 공정 시각화

pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동

Freely soluble in water (~15 g/100mL at 20°C)
적정 처방 pH 안전 윈도우 (pH 0 ~ 14 스펙트럼)pH 4.5 – 6.0
0245.5791114

권장 구간 밖(pH < 4.5 또는 pH > 6)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.

공정 가열 한계 온도 (Max Process Temp)≤ 55°C
25°C45°C60°C75°C85°C100°C

최대 55°C 가열 공정에서 열적 안정성이 유지됩니다.

계면활성·유화 HLB 스펙트럼 (0 ~ 20) & 미셀/액정 배열 시뮬레이터
O/W 수중유형 미셀 에멀전 (수분 크림·로션)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
생화학 신호전달 경로 (Biochemical Pathway Map)

세포·분자 타깃 작용 기전 플로우 다이어그램

1. 멜라닌 합성·이동 제어⊣ 억제·차단 (Inhibition)
티로시나아제(Tyrosinase) & 플라스민 신호 경로
⊣
표피 기미·과색소침착 감소 및 톤 균일화
2. 조효소 & 장벽 부스팅→ 촉진·활성 (Activation)
NAD+/NADP+ 풀 보충 & 세린 팔미토일트랜스퍼라제(SPT)
→
내인성 세라마이드 합성 증가 & 피지 분비 감소
처방 온톨로지 네트워크 그래프

권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도

+ NIACINAMIDE+ TRANEXAMIC ACID+ SODIUM METABISULFITE+ DISODIUM EDTA+ 3-O-ETHYL ASCORBIC…✕ ⚠️ 치명적 배합 금기 (하이드로퀴논…✕ 반드시 시트레이트-포스페이트 완충계(…ALPHA-ARBUTIN
노드 인터랙션 가이드

🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.

대표 상용명 참고 (상표법 제90조 제1항 제2호 설명적 표기)
Alpha-Arbutin (DSM / Pentapharm)

상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.

학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)

Tier 1 Synthesis

이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.

■ [1. 화학적 정체성 및 규격 (Chemical Identity & Standard Nomenclature)] - 표준명: 알파-알부틴 | INCI: ALPHA-ARBUTIN | CAS No.: 84380-01-8 | EC No.: 617-561-8 - 기원 및 분류: SYNTHETIC | 주요 기능: 항산화제, 미백제, 탈색제, 피부컨디셔닝제 - 물리화학 스펙: 분자식 C12H16O7 | 분자량 272.25 g/mol | LogP -1.35 | 이온성: non-ionic | PubChem CID 158637 - 7대 권역 공식 라벨 표기: KR [알파-알부틴] · EU [ALPHA-ARBUTIN] · US [ALPHA-ARBUTIN] · CN [α-熊果苷] · JP [α-アルブチン] · JP의약부외품 [α-アルブチン] ■ [2. 피부과학적 작용 기전 및 제형 내 역할 (Mechanism of Action & Function)] - 하이드로퀴논에 포도당이 알파-글리코사이드 결합(α-glucosidic bond)된 생합성 미백 성분으로, 베타-알부틴 대비 티로시나아제(Tyrosinase) 효소에 대한 경쟁적 저해 친화도가 약 10배 높습니다. 멜라노사이트의 세포 독성 없이 L-티로신이 L-도파(L-DOPA) 및 도파퀴논으로 산화되는 첫 단계를 정밀 차단하여 기미·주근깨·염증 후 색소침착(PIH)을 효과적으로 개선합니다. ■ [3. 글로벌 6대 권역 법정 규제 및 안전성 한도 (Layer 1 & Layer 2 Regulatory Matrix)] - 6개국 요약: KR: NOTED | EU: RESTRICTED | US: NONE | CN: NOTED | JP: NONE | ASEAN: RESTRICTED (중국 IECIC(2025) 등재번호 1005 (α-熊果苷)) - [EU / COMPOSITION / limited] (최대 0.5%): - [KR / COMPOSITION / noted]: - [CN / COMPOSITION / noted]: - [EU / OFFICIAL / restricted] (최대 2.0%): EU Omnibus 2024/996 (Annex III): 페이스 크림 최대 2.0%, 바디 로션 최대 0.5%. 하이드로퀴논(Hydroquinone) 불순물 잔류량을 불가피한 미량 수준으로 제한. - 공인 안전성·역사적 사용 농도(Layer 2): sccs (sccs_opinion, face_cream): 최대 2% / sccs (sccs_opinion, face_cream): 최대 2% / sccs (sccs_opinion, body_lotion): 최대 0.5% ■ [4. 제형군별 통상 배합 가이드 (Layer 3-A Formulation Dosage Guide)] - [aqueous_serum] 권장 범위: 0.2 ~ 2.0% (중앙값 1.0%, 근거: EU SCCS/1642/22 Final Opinion & EU Omnibus 2024/996) — 멜라닌 합성 효소 티로시나아제(Tyrosinase) 경쟁적 가역 저해 (EU 안면 한도 2.0%) - [emulsion_cream] 권장 범위: 0.2 ~ 2.0% (중앙값 1.0%, 근거: EU Regulation 2024/996 Annex III & SCCS/1642/22) — 브라이트닝 크림 (페이스 최대 2.0%, 바디로션 최대 0.5% EU 법정 한도) ■ [5. 연구원 공정 설계 · 안정성 · 배합 금기 (Layer 3-B Process & Compatibility)] - 투입 공정(Phase): Cool-down Phase (< 50°C; Must buffer pH to 4.5~6.0) - 적정 pH 구간: pH 4.5 ~ 6.0 | 공정 내열 온도: 최대 55°C | 전해질(염) 내성: HIGH - 배합 주의/금기: ⚠️ 치명적 배합 금기 (하이드로퀴논 독성 가수분해): pH 3.5 이하 강산(순수 비타민C, 고농도 AHA) 또는 pH 7.0 이상 알칼리 및 고온에서 글리코사이드 결합이 끊어져 법적 배합금지 독성 물질인 하이드로퀴논(Hydroquinone)이 유리되며 갈색으로 변색됨! - 배합 주의/금기: 반드시 시트레이트-포스페이트 완충계(Buffer)로 pH 4.8~5.8 고정 + 아황산수소나트륨(Sodium Metabisulfite 0.02~0.05%) + EDTA 병용 필수 - 시너지 추천 원료: NIACINAMIDE, TRANEXAMIC ACID, SODIUM METABISULFITE, DISODIUM EDTA, 3-O-ETHYL ASCORBIC ACID | 참고 상용 원료명: Alpha-Arbutin (DSM / Pentapharm) ■ [6. 학술 논문 및 공인 문헌 근거 (Peer-Reviewed Literature & Compendia)] - PMID 40705370 (2025, Drug Dev Ind Pharm): Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance thin-l - PMID 41346234 (2025, Nat Prod Res): Chemical composition and ameliorative effect of Cinnamomum burmanni (Nees & T.Nees) Blume essential oil nanoemulgel in U - PMID 42281907 (2026, JPRAS Open): Chitosan in aesthetic practice: A clinical narrative review of skin, scar, and scalp applications

근거 동료심사 학술 논문 (미국 NIH PubMed) (12)

Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance thin-layer chromatographic method [PMID: 40705370 · 2025]
Patel M, Kotak V, Patel R · Drug Dev Ind Pharm (2025)

The combined therapy of alpha arbutin, a natural derivative of hydroquinone, and niacinamide is well-regarded in skincare science. It leverages the unique properties of both actives, providing a multifaceted solution to esthetic and therapeutic skin concerns and supporting a comprehensive approach to skincare. This study aimed to develop a robust HPTLC method to determine alpha arbutin and niacinamide in a nanocosmeceutical using a comprehensive approach that includes risk assessment and Analytical Quality by Design. The critical method parameters influencing the HPTLC results were screened using a Plackett-Burman screening design, followed by optimization using a central composite optimization design and validation of the optimized method as per ICHQ2(R2). A novel HPTLC utilized pre-coated aluminum-backed HPTLC plates of Silica gel G 60&#x2009;F 254 using 10&#x2009;&#xb5;L/band injection volume, and the plate was developed using an isocratic mobile phase consisting of ethyl acetate: methanol: water (8.4:0.8:0.8v/v/v) in a twin trough chamber pre-saturated for 30 mins with vapors of 10&#x2009;mL of mobile phase. The separated components were detected at a wavelength of 273&#x2009;nm. The developed HPTLC method resulted in a retardation factor of 0.31&#x2009;&#xb1;&#x2009;0.02 for alpha arbutin and 0.42&#x2009;&#xb1;&#x2009;0.02 for niacinamide, respectively. Validation results revealed the HPTLC method's specificity (peak purity &#x2265; 0.999), linearity (over a studied concentration range of 200-800&#x2009;ng/band for alpha arbutin and 400-1600&#x2009;ng/band for niacinamide), sensitivity, accuracy, precision, and robustness. The developed robust HPTLC method was successfully implemented for the sustainable testing of the alpha arbutin and niacinamide in the nanocosmeceutical formulations.

Chemical composition and ameliorative effect of Cinnamomum burmanni (Nees & T.Nees) Blume essential oil nanoemulgel in UVB-induced skin photoaging C57BL/6 mice: in vivo and in silico studies [PMID: 41346234 · 2025]
Sari TA, Setiawansyah A, Rachmawati H, Melia Kartika C, Nurul Fadila N, Pranidya Tilarso D, Huda C, Melani F · Nat Prod Res (2025)

Photoaging is induced by prolonged UVB exposure, leading to the production of reactive oxygen species and subsequent oxidative stress. Cinnamomum burmanni essential oil (CBEO) is known for its potent antioxidant properties. This study aimed to develop a CBEO nanoemulgel formulation that provides optimal anti-photoaging effects will be proven by in vivo and in silico evaluation. Additionally, molecular docking studies were conducted to explore the interaction between the bioactive compounds and Matrix Metalloproteinase-2 (MMP-2), a key enzyme involved in the degradation of collagen during photoaging, to support the proposed mechanism of action. CBEO was found to contain 88.59% cinnamaldehyde as its main compound. Skin histopathological analysis demonstrated anti-photoaging effects of CBEO nanoemulgel were comparable to alpha arbutin both in vivo and in silico . The developed CBEO nanoemulgel demonstrates strong potential as a topical anti-photoaging agent, attributed to its rich content of bioactive compounds with MMP-inhibitory properties.

Chitosan in aesthetic practice: A clinical narrative review of skin, scar, and scalp applications [PMID: 42281907 · 2026]
Sydorchuk O, Choi WS, Shin JY, et al. · JPRAS Open (2026)

Chitosan is a cationic polysaccharide derived from chitin with film-forming, bioadhesive, antimicrobial, and wound-modulating properties, supporting increasing interest in aesthetic dermatology. To synthesize clinically relevant evidence on chitosan and its derivatives in aesthetic practice, focusing on skin barrier support, post-procedure recovery, acne, pigmentary disorders, and scalp applications. A narrative review of PubMed/Medline literature through February 2026 was conducted, prioritizing clinical trials, split-face studies, and relevant human data, supported by mechanistic and formulation evidence. Clinical studies suggest that chitosan hydrogels can support post-procedural recovery after ablative laser treatments with outcomes comparable to standard regimens and improved tolerability. Chitosan-based delivery systems enhance topical performance of actives such as nicotinamide, spironolactone, and &#x3b1;-arbutin in acne and melasma. In scalp applications, microneedling-assisted topical chitosan demonstrated improvements in hair density comparable to minoxidil in small studies. Chitosan shows potential as a barrier-supportive material, a delivery platform for topical actives, and an adjunct in scalp therapies. However, heterogeneity in formulations and limited study sizes restrict generalizability. Larger, standardized clinical trials are needed to define its role in aesthetic protocols.

A New Ultrasonic-Assisted One-Step Synthesis of Skin Lightening Bioactive Molecules by Using Fe/SiO2 as a Catalyst [PMID: 42253203 · 2026]
Mondal S, Dangate MS, Shaikh N · Curr Org Synth (2026)

&#x3b1;-Arbutin and its derivatives are widely recognized for their potent antioxidant activity and clinically validated skin-lightening effects. However, conventional synthetic strategies often rely on multistep protection-deprotection procedures, which reduce overall efficiency and limit scalability. The objective of this study was to develop a simple, one-step, and stereo- selective method for synthesizing &#x3b1;-Arbutin and related sugar derivatives using a heterogeneous solid acid catalyst under mild and sustainable reaction conditions. An ultrasonic-assisted glycosylation protocol was developed using Fe/SiO&#x2082; as a reusable solid acid catalyst. Reactions were performed with unprotected sugars in various solvents at 35-40 &#xb0;C. Ultrasonic irradiation was employed to enhance reaction kinetics and mass-transfer efficiency. Reaction progress, stereoselectivity, and product purity were monitored using TLC, NMR, and HPLC analyses. Catalyst recyclability and structural stability were evaluated across several reaction cycles. The protocol successfully produced &#x3b1;-Arbutin and multiple sugar derivatives in good to excellent yields (3a-3f). Ultrasonication significantly shortened reaction time while maintaining high product purity and selectivity. The Fe/SiO&#x2082; catalyst exhibited strong acidity, high catalytic performance, and excellent reusability. Unprotected sugars afforded the desired &#x3b1;-anomer with remarkable stereoselectivity across different solvents. The method avoided protection- deprotection steps and generated minimal by-products, demonstrating operational simplicity and efficiency. These findings highlight that coupling ultrasonic energy with a heterogeneous solid acid catalyst provides a greener, faster, and more selective glycosylation strategy that aligns with sustainable synthesis principles. The ultrasonic-assisted Fe/SiO&#x2082;-catalyzed one-step synthesis offers an efficient, environmentally compatible, and stereoselective route for producing &#x3b1;-Arbutin and its derivatives (3a- 3f), supporting their potential application in cosmetic and pharmaceutical formulations.

Toxicological evaluation of α-Arbutin, a skin depigmenting agent, with emphasis on mutagenicity assessment [PMID: 42173470 · 2026]
Lehn N, Grivicich I, de Sousa JT, et al. · Food Chem Toxicol (2026)

&#x3b1;-Arbutin is a skin-lightning agent that has been widely used in cosmetic and pharmaceutical formulations to treat hyperpigmentation disorders such as melasma and solar lentigo. It has fewer reported adverse effects in humans than hydroquinone and greater efficacy than &#x3b2;-Arbutin. However, few studies have focused on evaluating its toxicity profile, particularly its genetic toxicity. The aims of this study were to evaluate the cytotoxic, genotoxic, and mutagenic effects of &#x3b1;-Arbutin following a preliminary in silico analysis of toxicity-related parameters. Cytotoxicity and genotoxicity were assessed using the MTT and comet assays, respectively, whereas mutagenic activity was examined with the cytokinesis-block micronucleus cytome assay (CBMN-Cyt) and the Salmonella/microsome assay (Ames test). In the MTT assay, &#x3b1;-Arbutin exhibited an IC 50 (24&#xa0;h) of 43.5&#xa0;&#xb1;&#xa0;0.02&#xa0;&#x3bc;M and displayed genotoxic activity in L929 fibroblast cells treated for 3&#xa0;h, regardless of a 21&#xa0;h recovery period. Despite the observed genotoxic effects in the comet assay, no mutagenic activity was detected in either the Ames test or the CBMN-Cyt assay, in agreement with the in silico analysis, indicating that &#x3b1;-Arbutin did not induce gene or chromosomal mutations under the tested conditions.

Cosmetic potential of Ganoderma lucidum (Reishi) extract in a topical cream formulation [PMID: 41657122 · 2026]
Dikmen Kucuk S, Jabet P, Groso A, et al. · Int J Cosmet Sci (2026)

The primary objective of this study was to investigate the biological activities of freeze-dried Ganoderma lucidum (Reishi) extract obtained from hazelnut pruning waste and to compare its antioxidant, tyrosinase inhibitory and cytotoxic properties with two widely used cosmetic actives-argireline peptide and &#x3b1;-arbutin. Additionally, the study aimed to develop a topical cream formulation containing Reishi extract and to assess its microbiological safety, preservative efficacy and physicochemical stability under controlled environmental conditions. By integrating bioactivity evaluation with formulation performance, the research sought to determine the potential applicability of Reishi extract as a natural and multifunctional cosmetic ingredient suitable for anti-aging and skin-brightening applications. The antioxidant capacity of Reishi extract, argireline peptide and &#x3b1;-arbutin was determined using a copper(II)-based total antioxidant capacity assay. Tyrosinase inhibitory activity was measured with human tyrosinase sourced from MNT-1 melanoma cells, while cytotoxicity and safe dose limits were determined in HaCaT human keratinocyte cells via the AlamarBlue&#xae; method. A topical cream formulation was prepared using a multi-phase emulsification technique and characterized physicochemically. Microbiological safety was assessed according to Turkish Cosmetic Regulations, and preservative efficacy was determined through challenge testing. Stability assessments included temperature cycling, long-term storage at different temperatures and centrifugation tests, monitoring visual, physicochemical and microbiological parameters over a three-month period. Reishi extract demonstrated 861&#x2009;&#x3bc;mol TE/g antioxidant activity, 30% tyrosinase inhibition and a broader safety margin compared with argireline peptide and &#x3b1;-arbutin, which exhibited cytotoxicity at lower concentrations. The formulated cream retained a skin-compatible pH and stable viscosity, while showing no signs of phase separation, colour change or integrity loss under all storage conditions. Microbiological analysis confirmed microbial counts below regulatory limits, and challenge testing revealed rapid log reductions in all tested microorganisms, satisfying the acceptance criteria for preservative efficacy. Stability studies supported the physical robustness and microbiological safety of the final product throughout the evaluation period. Overall, the findings highlight Reishi extract as a bioactive-rich, safe and stable natural ingredient with strong potential for incorporation into cosmetic formulations. Its antioxidant performance, moderate tyrosinase inhibition and compatibility within the cream matrix support its use in multifunctional anti-aging and skin-brightening products. L'objectif principal de cette &#xe9;tude &#xe9;tait d'&#xe9;tudier les activit&#xe9;s biologiques de l'extrait de Ganoderma lucidum lyophilis&#xe9; (Reishi) obtenu &#xe0; partir des d&#xe9;chets d'&#xe9;lagage des noisettes et de comparer ses propri&#xe9;t&#xe9;s antioxydantes, inhibitrices de la tyrosinase et cytotoxiques avec deux actifs cosm&#xe9;tiques largement utilis&#xe9;s&#x2009;: un peptide d'argireline et d'&#x3b1;&#x2010;arbutine. Par ailleurs, l'&#xe9;tude visait &#xe0; d&#xe9;velopper une formulation de cr&#xe8;me topique contenant de l'extrait de Reishi et &#xe0; &#xe9;valuer sa s&#xe9;curit&#xe9; microbiologique, son efficacit&#xe9; de conservation et sa stabilit&#xe9; physicochimique dans des conditions environnementales contr&#xf4;l&#xe9;es. En int&#xe9;grant l'&#xe9;valuation de la bioactivit&#xe9; &#xe0; la performance de la formulation, la recherche a cherch&#xe9; &#xe0; d&#xe9;terminer l'applicabilit&#xe9; potentielle de l'extrait de Reishi en tant qu'ingr&#xe9;dient cosm&#xe9;tique naturel et multifonctionnel adapt&#xe9; aux applications anti&#x2010;&#xe2;ge et d'&#xe9;claircissement de la peau. M&#xc9;THODES: La capacit&#xe9; antioxydante de l'extrait d

Antioxidant, anti-melanogenic, anti-inflammatory, and cytotoxic constituents of Butea monosperma (Lam.) Kuntze flowers [PMID: 41518652 · 2026]
Preepram S, Tabtimmai L, Sonklin C, et al. · Nat Prod Res (2026)

Phytochemical investigation of Butea monosperma (Lam.) Kuntze flowers resulted in the isolation of seven compounds: medicarpin ( 1 ), sulfuretin ( 2 ), liquiritigenin ( 3 ), kaempferol ( 4 ), butein ( 5 ), iso-butrin ( 6 ), and butrin ( 7 ). Structures were identified by 1D and 2D NMR and confirmed with literature data. Antioxidant assays (DPPH &#x2022; , ABTS &#x2022;+ , FRAP) revealed butein ( 5 ) as the most active, followed by sulfuretin ( 2 ) and iso-butrin ( 6 ). Liquiritigenin ( 3 ) exhibited the strongest tyrosinase inhibition (IC 50 = 13.07&#x2009;&#xb1;&#x2009;2.58&#x2009;&#xb5;M) via competitive inhibition and effectively suppressed melanin production in MNT-1 cells, reducing pigmentation by 22-41%, outperforming &#x3b1;-arbutin without cytotoxicity. Compounds 4 and 5 showed potent anti-inflammatory activity, with NO inhibitory IC 50 values of 51.60 and 66.93&#x2009;&#xb5;M, respectively, while 2 , 3 , 5 , and 6 exhibited moderate cytotoxicity against HeLa (IC 50 = 34-38&#x2009;&#xb5;M) and HCT116 cells (IC 50 = 21-28&#x2009;&#xb5;M). Overall, B. monosperma flowers provide multifunctional natural products with promising cosmetic and pharmaceutical potential.

Insight Into the Cellular Activities of Tranexamic Acid as an Option for Melasma Treatment [PMID: 41147757 · 2026]
Hushcha Y, Giuliani AL, Fernanda M, et al. · Cell Biol Int (2026)

Melasma and other hyperpigmentation disorders represent a significant challenge in dermatology. Tranexamic acid (TXA), traditionally known for its antifibrinolytic activity via inhibition of plasminogen activation, has recently emerged as a promising depigmenting agent. However, its cellular effects on skin cells involved in melanogenesis remain poorly understood. In this study, we investigated TXA's impact on melanocytes, keratinocytes, and inflammatory cells. TXA directly inhibited melanin synthesis in B16 melanoma cells, with an additive effect when combined with &#x3b1;-arbutin. In keratinocytes and macrophages, TXA attenuated inflammatory responses triggered by the plasminogen/plasmin (Plg/Plm) pathway. Moreover, TXA reduced lipopolysaccharide-induced pro-inflammatory gene expression in mouse macrophages, suggesting interference with Toll-like receptor-mediated inflammation. These findings highlight TXA's multifaceted actions on skin cells involved in pigmentation and support its therapeutic potential in melasma and potentially other skin diseases.

Tetrahedral Framework Nucleic Acids as Thermal Loading Nanocarriers for Enhanced Inhibition of Melanin Synthesis [PMID: 40841180 · 2025]
Li P, Zhang W, Peng S, et al. · ACS Appl Mater Interfaces (2025)

This study aimed to address the limitations of &#x3b1;-arbutin (&#x3b1;-Arb) in transdermal delivery and melanin inhibition by developing a tetrahedral framework nucleic acid (tFNA)-based nanocarrier (tFNA@&#x3b1;-Arb). Unlike conventional carriers, tFNA was chosen for its unique tetrahedral structure and nucleic-acid-derived biocompatibility, which enables superior skin penetration. A first-reported thermal loading method for nucleic acids was applied to encapsulate &#x3b1;-Arb, significantly enhancing the loading efficiency from 60.83% to 76.85% without compromising drug activity. Subsequent transdermal experiments demonstrated that tFNA could deposit in the epidermis and accumulate within the skin. Zebrafish experiments further validated the excellent transdermal properties and safety profile of tFNA@&#x3b1;-Arb, which resulted in an effective melanin reduction with an inhibition rate of 95.65%. Mechanistically, tFNA@&#x3b1;-Arb specifically downregulated melanin-synthesis-related genes (validated by RT-qPCR). In C57BL/6J mice, it showed more pronounced melanin reduction, confirming the synergistic effect of tFNA's delivery capability and &#x3b1;-Arb's activity. This study presents a tFNA-based platform that innovates both carrier design and loading strategy, offering a transformative solution for enhancing &#x3b1;-Arb's efficacy in melanin inhibition.

Acute and Subacute Toxicity Study of α-Arbutin: An In Vivo Evidence [PMID: 40443353 · 2025]
Mishra P, Ahsan F, Mahmood T, et al. · J Appl Toxicol (2025)

&#x3b1;-Arbutin, a glucoside of hydroquinone, is utilized as a skin-lightening agent that inhibits human tyrosinase activity. Although it exhibits antioxidant and anti-inflammatory properties, limited research exists on its toxicological effects. This research investigates the oral toxicity of &#x3b1;-arbutin in both acute and subacute settings using Sprague-Dawley rats as test subjects. Female Sprague-Dawley rats underwent acute oral toxicity testing in accordance with OECD TG 425 guidelines. The rats received oral doses of 175, 550, 1750, and 2000&#x2009;mg/kg. Additionally, a subacute oral toxicity study following OECD TG 407 protocols was performed on both male and female rats. In this study, the animals were given daily oral doses of 250, 500, 1000, and 2000&#x2009;mg/kg for 28&#x2009;days. During acute and subacute oral toxicity assessments, no deaths or observable changes in behavior were noted at the administered doses. Examination of gross anatomy showed a significant decrease in the relative spleen weight of rats given &#x3b1;-arbutin at 250&#x2009;mg/kg compared to the control group. Male rats treated with &#x3b1;-arbutin exhibited markedly non-significantly increased levels of AST, ALT, and chloride ions. In contrast, mean corpuscular hemoglobin concentration levels notably decreased at lower &#x3b1;-arbutin doses relative to the control group. Brain histopathology of male rats revealed moderate inflammation with pyknotic nuclei, whereas the cortex showed extensive epithelial cell necrosis following the administration of 2000&#x2009;mg/kg of &#x3b1;-arbutin. The results showed that when given for a short time, &#x3b1;-arbutin is nontoxic till 2000&#x2009;mg/kg. The median lethal dose (LD 50 ) of &#x3b1;-arbutin is more than 2000&#x2009;mg/kg. A long-term toxicity study may be performed to validate the result. This study evaluated the acute and subacute oral toxicity of &#x3b1;-arbutin in Sprague-Dawley rats. No mortality or significant behavioral changes were observed up to 2000&#x2009;mg/kg. However, at higher doses, male rats exhibited elevated liver enzymes and chloride ions, along with brain inflammation and cortical necrosis. Overall, &#x3b1;-arbutin showed no remarkable toxicity at tested doses, with an LD 50 exceeding 2000&#x2009;mg/kg, warranting further long-term safety assessments.

Efficacy and Safety of a Topical Formulation Containing Trihydroxybenzoic Acid Glucoside and α-Arbutin, Applied Along With a Sunscreen: A Noncomparative, Prospective, Interventional Study in Indian Females With Facial Melasma or Dark Spots [PMID: 39943675 · 2025]
Gabhane M, Patil R, Dharmadhikari S, et al. · J Cosmet Dermatol (2025)

Skin hyperpigmentation is a dermatological concern for pigmented skin phototypes. Despite availability of multiple treatment options, hyperpigmentation management continues to be a challenge. Efficacy and safety assessment of the skincare regimen [topical formulation of trihydroxybenzoic acid glucoside 10% (THBG) and &#x3b1;-arbutin 2% (twice-daily)&#x2009;+&#x2009;sunscreen (once daily)] in Indian females with pigmentary spots (facial dark spots or melasma). This prospective, open-label, single-arm, interventional study was conducted in Indian females (n&#x2009;=&#x2009;124), aged 18-45&#x2009;years, having FitzPatrick skin type III-IV, dull skin, and facial dark spots or melasma. Efficacy of 90-day skincare regimen was evaluated using mexameter, modified melasma area and severity index (mMASI) score, cross-polarized light photography, chromameter, and color-luminosity-brightness-transparency (CLBT) technique. Student's t-test (paired data) was used for statistical analysis. In efficacy analysis [modified intention-to-treat (mITT) population], 120 subjects were included. Melanin content of pigmentary spots (on mexametry) significantly reduced (-16.3%, p&#x2009;&lt;&#x2009;0.001) at Day 90 versus baseline. Significant reduction in severity of melasma was observed (-18.4% in mMASI score) at Day 90. Significant improvement in &#x394;Eab (-8.7%) (change in color difference between pigmentary spot and normal skin) on cross-polarized photographs, in skin-brightening parameters L* (relative brightness/lightness) (-2.7%), ITA&#xb0; (individual typology angle) (-37.7%), and &#x394;E* (skin-tone evenness) (-19.0%) using chromameter. Significant improvement in skin radiance was observed in CLBT parameters, color (pink: 32.8%, yellow: -5.5%, and olive:&#x2009;-7.8%), luminosity (6.0%), brightness (4.6%), and transparency (0.2%). Regimen did not cause itching, burning, or irritation. Skincare regime of 10% THBG and 2% &#x3b1;-arbutin along with sunscreen was effective in reducing pigmentary spots (dark spots and melasma) and was well tolerated in Indian women. Clinical Trial Registry of India (CTRI Reg. No. CTRI/2021/11/038345; date: 30/11/2021).

Cuphea hookeriana: Phytochemical Profile and the Cosmeceutical and Dermatological Properties of Its Active Fraction from the Whole Plant [PMID: 39860181 · 2025]
Wu X, Wanyan MF, Shi BB, et al. · Molecules (2025)

Natural products and botanicals continue to play a very important role in the development of cosmetics worldwide. The chemical constituents of a fine active fraction of the whole plant extract of Cuphea hookeriana Walp., and the tyrosinase and matrix metalloproteinase-1 (MMP-1) inhibitory and antioxidant activities of this fraction were investigated. The fine active fraction was mainly composed of seven natural compounds. The fine active fraction demonstrated substantial in vitro antioxidant potential using the ABTS assay (IC 50 1.66 &#x3bc;g/mL). It inhibited the two target enzymes (tyrosinase and MMP-1) engaged in skin whitening and aging with comparable IC 50 values to the reference drugs. Acute toxicity experiments showed that mice gavage orally with the fine active fraction had no significant animal toxicity at a dose of 2000 mg/kg, and the maximum tolerated dose (MTD) in mice was greater than 2000 mg/kg. In a model where ultraviolet light promotes the increase in melanin secretion in guinea pig skin tissues, both &#x3b1;-arbutin and the fine active fraction can reduce melanogenesis, and the effect of the fine active fraction is better than that of &#x3b1;-arbutin.

자주 묻는 질문 (AEO 스니펫 최적화 FAQ)

Q1. 알파-알부틴 (ALPHA-ARBUTIN)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
한국 식약처 표준명은 '알파-알부틴', 미국 PCPC 및 유럽 CosIng INCI 표기는 'ALPHA-ARBUTIN', 중국 NMPA IECIC 표준명은 'α-熊果苷', 일본 화장품 표시명칭은 'α-アルブチン'입니다.
Q2. 알파-알부틴의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
한국(KR: noted), 유럽(EU: restricted), 미국(US: none), 중국(CN: noted), 일본(JP: none), 아세안(ASEAN: restricted) 고시 기준을 준수하여 처방해야 합니다.
Q3. 제형 설계 시 알파-알부틴의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
대표 제형군(aqueous_serum) 기준 통상 0.2~2%(권장 중앙값 1%) 범위로 투입하며, 적정 pH는 4.5~6입니다.
Q4. 알파-알부틴 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
주요 권장 시너지 조합은 NIACINAMIDE, TRANEXAMIC ACID, SODIUM METABISULFITE, DISODIUM EDTA, 3-O-ETHYL ASCORBIC ACID이며, 배합 주의사항은 ⚠️ 치명적 배합 금기 (하이드로퀴논 독성 가수분해): pH 3.5 이하 강산(순수 비타민C, 고농도 AHA) 또는 pH 7.0 이상 알칼리 및 고온에서 글리코사이드 결합이 끊어져 법적 배합금지 독성 물질인 하이드로퀴논(Hydroquinone)이 유리되며 갈색으로 변색됨!; 반드시 시트레이트-포스페이트 완충계(Buffer)로 pH 4.8~5.8 고정 + 아황산수소나트륨(Sodium Metabisulfite 0.02~0.05%) + EDTA 병용 필수입니다.