DIPOTASSIUM GLYCYRRHIZATE
화장품에서 다이포타슘글리시리제이트 (DIPOTASSIUM GLYCYRRHIZATE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?
다이포타슘글리시리제이트(표준 INCI: DIPOTASSIUM GLYCYRRHIZATE, CAS 번호: 68797-35-3)은 화장품 처방에서 주로 보습제, 피부컨디셔닝제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.1–5.0%(적정 pH 4.5–7.5) 범위에서 안정적으로 처방됩니다.
7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스
각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건| 국가·규제 트랙 | 공식 고시 전성분 표기명 | 원클릭 복사 |
|---|---|---|
| ① 한국 (MFDS 화장품 한글 표준명) | 다이포타슘글리시리제이트 | |
| ② 한국 구명칭 (개정 전 이력 · 301 리다이렉트) | 디포타슘글리시리제이트 | |
| ③ 유럽 (EU CosIng EC 1223/2009) | DIPOTASSIUM GLYCYRRHIZATE | |
| ④ 미국 일반화장품 (US PCPC / MoCRA INCI) | DIPOTASSIUM GLYCYRRHIZATE | |
| ⑤ 미국 OTC (FDA Active Ingredient Monograph) | — (비-OTC 일반 화장품 원료) | — |
| ⑥ 중국 (NMPA IECIC 표준 중문명) | 甘草酸二钾 | |
| ⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW) | グリチルリチン酸2K · [QD: グリチルリチン酸ジカリウム] |
Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태
| 권역 | 규제 상태 | 배합 한도 | 제한 조건 및 1차 법원 출처 |
|---|---|---|---|
| 한국 (MFDS) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 유럽 (CosIng) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 미국 (FDA/CIR) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 중국 (NMPA) | 등재·허용 | GMP | IECIC Entry #2397 |
| 일본 (MHLW) | 제한 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 아세안 (ACD) | 미규제 | GMP | 공식 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.
| 안전성 평가 기준 | 적용 부위·유형 | 안전 농도 범위 | 판정 결과 및 문헌 번호 |
|---|---|---|---|
| 중국 IECIC 최고역사사용량 | leave_on | ≤ 2% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 02455 (2025) |
| 중국 IECIC 최고역사사용량 | rinse_off | ≤ 1% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 02455 (2025) |
각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션
단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.
pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동
권장 구간 밖(pH < 4.5 또는 pH > 7.5)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.
최대 70°C 가열 공정에서 열적 안정성이 유지됩니다.
세포·분자 타깃 작용 기전 플로우 다이어그램
학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)
Tier 2 Synthesis이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.
근거 동료심사 학술 논문 (미국 NIH PubMed) (8)
Efficacy of a Topical Formulation on Skin Hydration and Barrier Function in Individuals With Xerosis: A 28-Day Randomized, Split-Leg, Untreated-Controlled Trial [PMID: 42108609 · 2026]
Xerosis cutis is characterized by impaired epidermal barrier function, increased transepidermal water loss (TEWL), reduced hydration, and symptoms such as pruritus. To evaluate the efficacy, tolerability, and subjective perception of a topical formulation containing panthenol, niacinamide, and dipotassium glycyrrhizate in improving skin hydration and barrier function in subjects with dry, sensitive skin. In this randomized, intra-individual, split-leg clinical trial, subjects with xerosis applied the test emollient twice daily for 28 days to one pretibial area. The contralateral leg remained untreated as control. Assessments were performed at baseline (T0), 30 min, 24 h, 48 h, day 7 and day 28. Primary outcomes were corneometric stratum corneum hydration and TEWL. Secondary outcomes included deep skin conductance ("deep moisturization"), desquamation index, surface microrelief regularity (SEr), scaliness (SEsc), dermatologist-rated clinical signs, and participant self-assessment. Thirty-five participants (31 women; mean age 47.3 ± 2.0 years) were included. Compared with baseline (hydration: 21.3 ± 1.0 c.u., 95% CI: 19.3-23.3; TEWL: 9.2 ± 0.3 g/h/m 2 , 95% CI: 8.6-9.8) and untreated control, the treated leg showed greater corneometric hydration at all time points: 66.2% (33.9 ± 1.4 c.u., 95% CI: 31.1-36.7) at day 7 and 74.1% (35.2 ± 1.2 c.u., 95% CI: 32.8-37.6) at day 28 (all p < 0.001). TEWL decreased by 11.3% (8.2 ± 0.2 g/h/m 2 , 95% CI: 7.8-8.6) and 13.5% (7.9 ± 0.2 g/h/m 2 , 95% CI: 7.5-8.3), respectively (all p < 0.05). Deep moisturization increased by 5.7% (39.5 ± 0.9 μS at day 7, 95% CI: 37.7-41.3) and 7.3% (41.1 ± 0.8 μS at day 28, 95% CI: 39.5-42.7) (p < 0.05). The desquamation index decreased by 13.0% (29.50% ± 1.67% at day 7, 95% CI: 26.1-32.9) and 15.8% (26.77% ± 1.25% at day 28, 95% CI: 24.2-29.3), SEr increased by 46.9% (3.38 ± 0.15 a.u. at day 7, 95% CI: 3.08-3.68) and 54.2% (3.47 ± 0.15 a.u. at day 28, 95% CI: 3.17-3.77), and SEsc decreased by 67.0% (0.81 ± 0.12 a.u. at day 7, 95% CI: 0.57-1.05) and 76.3% (0.51 ± 0.07 a.u. at day 28, 95% CI: 0.37-0.65), respectively (all p < 0.05). Dermatologist assessments at all time points showed significant clinical improvement in dryness and pruritus in all participants (p < 0.001). Complete resolution was observed in all participants according to the 5-point scale, though this may reflect a floor effect given mild baseline scores. The topical formulation appeared to be an effective and well-tolerated emollient; however, the absence of a vehicle control precludes attribution of effects specifically to the active ingredients. Patient-reported outcomes should be interpreted with caution due to the unblinded design.
A upper critical solution temperature- and synergistic antioxidant-responsive tremella polysaccharide hydrogel for enhancing diabetic wound healing [PMID: 42056802 · 2026]
The high-sugar environment caused persistent inflammation at diabetic wound sites, resulting in impaired healing. Hydrogel dressings proved effective in addressing these issues. However, many still demonstrated insufficient wet adhesion, flexibility, or painless removability. These shortcomings often led to bleeding during dressing changes and resulted in further injury. To overcome these limitations, we developed an upper critical solution temperature (UCST) hydrogel. This material exhibited excellent mechanical properties and synergistic antioxidant effects, promoting the healing of diabetic wounds. This hydrogel was fabricated from a copolymer network of gelatin, sorbitol, and tremella polysaccharide (TP), with the addition of ergothioneine (EGT) and dipotassium glycyrrhizate (DPG) (ED@SG-T0.8). The abundant hydrogen bonds within the system improved the hydrogel's stability and tensile strength. This contributed to its outstanding mechanical properties and tight adhesion to skin. The hydrogel's straw-like structure facilitates efficient water and substance exchange, while its sol-gel transition at 43 °C (within skin tolerance range) prevents secondary injury during dressing changes. Notably, this study demonstrates synergistic antioxidant interactions between EGT and DPG, and between DPG and SG-T0.8, thereby effectively modulating the inflammatory micro-environment. In a type I diabetic mouse model, it accelerated wound healing by upregulating CD31 (promoting microvascular formation) and modulating cytokines (increased IL-10, decreased TNF-α), leading to significant MMP-9 downregulation. This study demonstrated that the ED@SG-T0.8 had a great potential in the treatment of diabetic wounds.
A Split-Face Randomized Study on the Efficacy of a Platinum-Liposome-Based Facial Mask Containing Soothing Ingredients for Post-Photorejuvenation Skin Recovery [PMID: 40957858 · 2025]
Photorejuvenation is commonly employed to improve skin appearance but frequently leads to transient irritation and temporary impairment of skin barrier function. Incorporating platinum (Pt)-liposome technology along with soothing ingredients such as panthenol, dipotassium glycyrrhizate, madecassoside, and Portulaca oleracea extract is expected to offer enhanced reparative and anti-inflammatory effects, helping to alleviate post-procedural skin sensitivity and restore barrier integrity. This study aimed to evaluate the efficacy of a Pt-liposome-based facial mask in promoting skin recovery and soothing irritation post-photorejuvenation. Furthermore, the study assessed potential synergistic benefits from combining Pt-liposomes with established soothing agents. We initially assessed the reparative effects of Pt-liposomes using a 3D epidermal skin model and normal human epidermal keratinocytes (NHEK), evaluating parameters such as stratum corneum thickness, cholesterol content, ceramide chain length, and inflammatory responses (IL-8 mRNA expression) following lipopolysaccharide (LPS) stimulation. A randomized, split-face clinical trial involving 30 subjects who underwent photorejuvenation treatment was then conducted. Each participant applied the Pt-liposome-infused facial mask to one side of the face and a control product on the other side. Skin hydration, transepidermal water loss (TEWL), and erythema, tightness, dryness, and scaliness were assessed using objective instrumentation and subjective evaluations at baseline and various intervals up to 14 days post-treatment. In vitro testing showed that Pt-liposomes significantly increased stratum corneum thickness, cholesterol levels, and ceramide chain length (p < 0.01). Pt-liposomes also reduced histamine-induced calcium influx in NHEK cells (p < 0.01). In LPS-stimulated THP-1 cells, combined treatment with Pt-liposomes and soothing agents resulted in a greater reduction in IL-8 mRNA expression compared to either component alone (p < 0.01). Clinical measurements indicated that the application of the Pt-liposome-based facial mask significantly increased skin hydration and reduced TEWL compared to control (p < 0.001) from Day 1 to Day 14. Subjective and dermatological evaluations showed statistically significant improvements in erythema, tightness, dryness, and scaliness on the treated side at all measured time points. No adverse reactions were reported. The Pt-liposome-infused facial mask can effectively promote skin barrier repair, alleviate irritation, and enhance hydration following photorejuvenation. Its synergistic combination with soothing ingredients provides rapid relief from irritation and sustained therapeutic benefits, supporting its potential as a safe and effective option for post-procedural skincare.
Injectable thermo-sensitive and wide-crack self-healing hydrogel loaded with antibacterial anti-inflammatory dipotassium glycyrrhizate for full-thickness skin wound repair [PMID: 35245682 · 2022]
Severe skin injuries are hard to repair and susceptible to bacterial infection. Development of a versatile antimicrobial anti-inflammatory hydrogel dressing that eliminates concern over antibiotic resistance is urgently needed but remains an elusive goal. Our research, described herein, the design and fabrication of a new family of supramolecular hydrogels based on hydroxypropyl chitosan (HPCS) and poly(N-isopropylacrylamide) (PNIPAM) may prove to be that goal. Employing the reversible cross-linking by β-cyclodextrin (β-CD) and adamantyl (AD) pre-assembly, the hydrogels can be formed in a facile one-pot method. Additionally, the structure and performance of the hydrogels can be controlled by a simple adjustment of the AD content. The obtained hydrogels exhibit an abundance of desired properties; they are injectable, thermosensitive, highly ductile, self-healable (will self-heal recurring damage to the hydrogel bandage of up to several millimeters wide), biocompatible, and have antimicrobial activity against Staphylococcus aureus when infused with dipotassium glycyrrhizinate (DG). Using a mouse full-thickness skin defect model, in vivo wound healing evaluations revealed that the DG-loaded hydrogels (HP-3/DG10) applied to the wound resulted in rapid wound closure. The hydrogels promoted efficient tissue remolding, collagen deposition, decreased inflammation and performed better than the control groups of commercial Tegaderm TM film and 3M dressing. Given their multifunctionality and in vivo efficacy, the DG-loaded HP hydrogels hold great potential as a wound dressing for full-thickness skin repair. STATEMENT OF SIGNIFICANCE: Injectable hydrogels are receiving increasing attention as an ideal wound dressing. To the best of our knowledge, however, injectable and wide-crack self-healing hydrogel dressings have been hardly studied. A versatile antimicrobial hydrogel without drug resistance or cytotoxicity is also highly required. Therefore, in the present study, we constructed injectable thermosensitive and wide-crack self-healing hydrogels with antibacterial and anti-inflammatory properties. These hydrogels were developed through novel strategies of the wide-crack self-healing design and the loading of the bioactive antibacterial and anti-inflammatory agent dipotassium glycyrrhizinate. The simple preparation method and multifunctionality of the studied hydrogel composites may provide important insights for the development of future biomaterials for wound dressings and other biomedical applications.
An open-label, investigator-initiated, single-center, prospective, pilot clinical study to evaluate the efficacy of a skin whitening serum applied twice daily combined with a spot-preventing SPF50+ sunscreen in healthy female subjects with melasma hyperpigmentation [PMID: 34087055 · 2022]
Melasma is a common skin disorder characterized by alterations in normal skin pigmentation. The objective was to evaluate the efficacy and safety of a skin whitening serum containing niacinamide, hydroxyphenoxy propionic acid, dipotassium glycyrrhizate, glycolic acid, and 4-n-butylresorcinol applied twice daily combined with a spot-preventing SPF50+ sunscreen for treatment of melasma. Twelve healthy Caucasian women with melasma (Fitzpatrick skin types II-IV) were enrolled in this pilot clinical study. Efficacy evaluations were performed at baseline and weeks 4, 8, and 12 of treatment and included clinical and instrumental assessments. All endpoints for melasma hyperpigmentation showed a statistically significant improvement from baseline to the end of the study. There was only one dropout. No signs of irritation or discomfort were observed at baseline, w4, w8, or w12. An overall improvement in melasma was observed both clinically and on reflectance confocal microscopy (RCM). This topical skin whitening serum had favorable outcomes for the treatment of melasma hyperpigmentation in adult women, as demonstrated on investigator and instrumental assessments. The results of this pilot study need to be confirmed in randomized, controlled studies with a larger sample size.
Clinical Evaluation of a Multi-Modal Facial Serum That Addresses Hyaluronic Acid Levels in Skin [PMID: 28915283 · 2017]
Hyaluronic acid (HA), the major glycosaminoglycan present in the human skin, is a key contributor to water retention and mechanical support in skin. The level, size, and functionality of cutaneous HA are known to diminish with age. Topical treatments designed to increase the HA content of skin have been met with limited success. The purpose of this study was to evaluate the tolerance and efficacy of a multi-modal facial serum containing HA, Proxylane (C-Xyloside), purple rice extract, and dipotassium glycyrrhizate in addressing HA levels in skin. A 12-week, single center, clinical study was conducted on 59 women with mild to moderate photodamage. Clinical grading to assess the efficacy and tolerability was conducted on the face at baseline and at weeks 4, 8, and 12. Bioinstrumentation measurements were taken, including corneometer, tewameter, ultrasound, and standardized digital imaging. A randomized subset of 20 subjects from the study population had 3 mm punch biopsies collected for quantitative RT-PCR analysis from 2 sites on the face at baseline and week 12. Additionally, a 4-week, single center, clinical study was conducted on the photodamaged forearms of 12 subjects. At both baseline and week 4, a 4 mm punch biopsy was obtained from the subjects' randomized forearms. Biopsy samples were subjected to immunohistochemical staining and analysis of HA content. Statistically-significant improvements in all facial skin attributes (weeks 4, 8, and 12), stratum corneum hydration (week 12), and transepidermal water loss (week 12) were observed. Tolerability was excellent, with no increases in irritation parameters noted. A significant increase of HA content in skin after 4 weeks of treatment was observed. By PCR analysis, there was a significant increase in hyaluronan synthase 2, as well as a significant increase in collagen type 1a1 after 12 weeks of application. The findings suggest that this novel topical facial serum is capable of stimulating HA and skin extracellular matrix components, as well as improving skin hydration and skin quality in women with mild to moderate photodamage. <p><em>J Drugs Dermatol. 2017;16(9):884-890.</em></p>.
Allergic contact dermatitis caused by arbutin and dipotassium glycyrrhizate in skin-lightening products [PMID: 28612442 · 2017]
Final report on the safety assessment of Glycyrrhetinic Acid, Potassium Glycyrrhetinate, Disodium Succinoyl Glycyrrhetinate, Glyceryl Glycyrrhetinate, Glycyrrhetinyl Stearate, Stearyl Glycyrrhetinate, Glycyrrhizic Acid, Ammonium Glycyrrhizate, Dipotassium Glycyrrhizate, Disodium Glycyrrhizate, Trisodium Glycyrrhizate, Methyl Glycyrrhizate, and Potassium Glycyrrhizinate [PMID: 17613133 · 2007]
Glycyrrhetinic Acid and its salts and esters and Glycyrrhizic Acid and its salts and esters are cosmetic ingredients that function as flavoring agents or skin-conditioning agents - miscellaneous or both. These chemicals may be isolated from licorice plants. Glycyrrhetinc Acid is described as at least 98% pure, with 0.6% 24-OH-Glycyrrhetinic Acid, not more than 20 mu g/g of heavy metals and not more than 2 mu g/g of arsenic. Ammonium Glycyrrhizate has been found to be at least 98% pure and Dipotassium Glycyrrhizate has been found to be at least 95% pure. Glycyrrhetinic Acid is used in cosmetics at concentrations of up to 2%; Stearyl Glycyrrhetinate, up to 1%; Glycyrrhizic Acid, up to 0.1%; Ammonium Glycyrrhizate, up to 5%; Dipotassium Glycyrrhizate, up to 1%; and Potassium Glycyrretinate, up to 1%. Although Glycyrrhizic Acid is poorly absorbed by the intestinal tract, it may be hydrolyzed to Glycyrrhetinic Acid by a beta -glucuronidase produced by intestinal bacteria. Glycyrrhetinic Acid and Glycyrrhizic Acid bind to rat and human albumin, but do not absorb well into tissues. Glycyrrhetinic Acid and Glycyrrhizic Acid and metabolites are mostly excreted in the bile, with very little excreted in urine. Dipotassium Glycyrrhizate was undetectable in the receptor chamber when tested for transepidermal permeation through pig skin. Glycyrrhizic Acid increased the dermal penetration of diclofenac sodium in rat skin. Dipotassium Glycyrrhizate increased the intestinal absorption of calcitonin in rats. In humans, Glycyrrhetinic Acid potentiated the effects of hydrocortisone in the skin. Moderate chronic or high acute exposure to Glycyrrhizic Acid, Ammonium Glycyrrhizate, and their metabolites have been demonstrated to cause transient systemic alterations, including increased potassium excretion, sodium and water retention, body weight gain, alkalosis, suppression of the renin-angiotensis-aldosterone system, hypertension, and muscular paralysis; possibly through inhibition of 11beta -hydroxysteroid dehydrogenase-2 (11beta -OHSD2) in the kidney. Glycyrrhetinic Acid and its derivatives block gap junction intracellular communication in a dose-dependent manner in animal and human cells, including epithelial cells, fibroblasts, osteoblasts, hepatocytes, and astrocytes; at high concentrations, it is cytotoxic. Glycyrrhetinic Acid and Glycyrrhizic Acid protect liver tissue from carbon tetrachloride. Glycyrrhizic Acid has been used to treat chronic hepatitis, inhibiting the penetration of the hepatitis A virus into hepatocytes. Glycyrrhetinic Acid and Glycyrrhizic Acid have anti-inflammatory effects in rats and mice. The acute intraperitoneal LD(50) for Glycyrrhetinic Acid in mice was 308 mg/kg and the oral LD(50) was > 610 mg/kg. The oral LD(50) in rats was reported to be 610 mg/kg. Higher LD(50) values were generally reported for salts. Little short-term, subchronic, or chronic toxicity was seen in rats given ammonium, dipotassium, or disodium salts of Glycyrrhizic Acid. Glycyrrhetinic Acid was not irritating to shaved rabbit skin, but was considered slightly irritating in an in vitro test. Glycyrrhetinic Acid inhibited the mutagenic activity of benzo[a]pyrene and inhibited tumor initiation and promotion by other agents in mice. Glycyrrhizic Acid inhibited tumor initiation by another agent, but did not prevent tumor promotion in mice. Glycyrrhizic Acid delayed mortality in mice injected with Erlich ascites tumor cells, but did not reduce the mortality rate. Ammonium Glycyrrhizate was not genotoxic in in vivo and in vitro cytogenetics assays, the dominant lethal assay, an Ames assay, and heritable translocation tests, except for possible increase in dominant lethal mutations in rats given 2000 mg/kg day(-1) in their diet. Disodium Glycyrrhizate was not carcinogenic in mice in a drinking water study at exposure levels up to 12.2 mg/kg day(-1) for 96 weeks. Glycyrrhizate salts produced no reproductive or developmental toxicity in rats, mice, gol
자주 묻는 질문 (AEO 스니펫 최적화 FAQ)
- Q1. 다이포타슘글리시리제이트 (DIPOTASSIUM GLYCYRRHIZATE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
- 한국 식약처 표준명은 '다이포타슘글리시리제이트', 미국 PCPC 및 유럽 CosIng INCI 표기는 'DIPOTASSIUM GLYCYRRHIZATE', 중국 NMPA IECIC 표준명은 '甘草酸二钾', 일본 화장품 표시명칭은 'グリチルリチン酸2K'입니다.
- Q2. 다이포타슘글리시리제이트의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
- 한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: restricted), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
- Q3. 제형 설계 시 다이포타슘글리시리제이트의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
- 일반 스킨케어 제형에서 적정 pH 4.5~7.5 구간에서 안정적으로 배합됩니다.
- Q4. 다이포타슘글리시리제이트 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
- 주요 권장 시너지 조합은 판테놀, 세라마이드엔피, 하이드롤라이즈드해면이며, 배합 주의사항은 극단적 강산/강염기 조건 회피입니다.