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Overview of Recombinant Skin Models and Progress in Their Application in Vitro Assessment of Toxicity and Efficacy

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China Detergent & Cosmetics 2023年第1期8卷 38-44页

作者： Zhang Bowen Xu Qiufeng GU Wu Zhang Zhichun Dai Yumeng Han Zhiyang Xu Mingkai Wang Yu Key Laboratory of Pollution Ecology and Environment Engineering Chinese Academy of SciencesChina Shenyang Zeer Testing Service Co. Ltd.China

A recombinant skin model is a model in which skin cells are grown in vitro on a bioactive scaffold and provided with adequate nutrition to promote cell proliferation and differentiation to produce a mock skin structure and biological features. The development of recombinant skin models allows for effective and scientifically sound in vitro evaluation tests. This review briefly summarizes the overview of recombinant skin models and the progress of their application in in vitro evaluation which focuses on three aspects: skin irritation, skin corrosivity, and anti-skin aging. Moreover, an outlook on the future development of recombinant skin models is also provided in this review.

关键词： recombinant skin model in vitro evaluation irritation corrosiveness anti-skin aging

β-Elemene-loaded polymeric micelles intensify anti-carcinoma efficacy and alleviate side effects

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中国化学快报：英文版 2020年第3期31卷 915-918页

作者： Qiaoqiao Hu Lan Bai Zejiang Zhu Zhengying Su Peng Bai Minghai Tang Caixia Dou Junfeng Yan Rongsheng Tong Wuyu Zhang Lijuan Chen Lulu Cai Personalized Drug Therapy Key Laboratory of Sichuan Province Department of PharmacySichuan Provincial People's HospitalSchool of MedicineUniversity of Electronic Science and Technology of ChinaChengdu 610072China State Key Laboratory of Biotherapy and Cancer Center West China HospitalSichuan University and Collaborative Innovation CenterChengdu 610041China Department of Chemistry University of LouisvilleLouisvilleKY 40292United States

β-Elemene is a volatile oil used for the treatment of cancer,but poor solubility,low bioavailability,and various adverse reactions limit its application.For amelio rating risks of the venous toxicity ofβ-elemene,intravenously injectable micelle ofβ-elemene was prepared using the thin-film hydration method.The results pointed out the micelles were uniformly spherical with about 20.96±0.1966 nm in average diameter and exhibited high entrapment efficiency(99.02%±0.88%).As revealed by drug release studies in vitro,β-elemene micelles had sustained drug release.Compared with freeβ-elemene,the micelles increased the drug cellular uptake and enhanced the anti-tumor effect in vitro through retarding cell cycle and inducing apoptosis.Meanwhile,the elevated se rum stability o fβ-elemene micelles implied less drug leakage and reduced toxicity.The wound healing and tube formation assay in vitro demonstrated the anti-metastasis and anti-angiogenesis effects ofβ-elemene micelles.Moreover,the pharmacokinetics study showed the AUC and T1/2 ofβ-elemene in micelle group were 1.79 and 1.62 times of that in free fi-elemene group,suggesting the circulation time ofβ-elemene in the blood had been prolonged.In addition,β-elemene micelles showed a favorable antitumor response compared with theβ-elemene solution on C26 colon cance r-bearing mice model.Local irritation study investigated in rabbits indicated that theβ-elemene micelles strikingly mitigated the irritation to the injection sites compared with freeβ-elemene.These results proved that the micelle could be a good candidate as an auspicious drug delivery system ofβ-elemene for the prospective clinical treatment of carcinoma.

关键词： β-Elemene mPEC-PCL micelles Antitumor Colon cancer irritation

Safety Assessment of a Novel Topical Vehicle for Personalized Treatments in Acne

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Journal of Cosmetics, Dermatological Sciences and Applications 2022年第4期12卷 187-200页

作者： Hudson Polonini Anton Ameneiro-Alvarez Clark Zander Fagron BV Rotterdam The Netherlands Fagron US Saint Paul USA

Acne vulgaris is a common inflammatory disease of the pilosebaceous unit, with a profound impact on the quality of life of patients. In this work, we aimed to study the safety characteristics of CleodermTM, a novel functional semisolid vehicle developed for the compounding of treatments for acne and oily skin. The primary and cumulative irritation and sensitization potential were evaluated in 54 healthy volunteers in a comparative single-blinded study, while the acnegenic and comedogenic potential of the product were assessed in 31 healthy volunteers with combination to oily skin through a non-comparative study. CleodermTM was applied (0.05 g/cm2) in filter paper discs in both studies. For the evaluation of the irritation and sensitization potential, the investigational product, or a control (0.9% NaCl) was applied to the right or left scapular area of the study subjects. No clinical reactions were observed during the induction or challenge phases, suggesting that CleodermTM presents no irritating or allergenic potential. Regarding acnegenicity and comedogenicity, no significant increase in the number of acne lesions linked to the application of the product in four areas of the face was reported, indicating that CleodermTM appears not to display acnegenic and comedogenic potential. Furthermore, over 60% of the study subjects exhibited a decrease in the number of acne lesions after product use. These results show that CleodermTM exhibited no irritating, sensitizing, acnegenic or comedogenic potential, and suggest that it can be considered safe under the study conditions and that the claims dermatologically tested, clinically tested, and non-comedogenic/acnegenic can be supported.

关键词： Acne Vulgaris Personalized Medicine irritation Sensitization Comedogenicity

Evaluation of the Skin irritation and Sensitization Potential of the Cussons Baby Sensicare Skin Range of Products in Healthy Volunteers

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Journal of Cosmetics, Dermatological Sciences and Applications 2019年第3期9卷 207-215页

作者： Yullya S. Mulyanti Yuliarni Busarin Kasemchainan Partha P. Mitra Paul Evans Haryono Hartono R&D Formulation PZ Cussons Indonesia Jakarta Indonesia

Introduction: The Cussons Baby Sensicare Range is a newly developed set of products specially formulated for newborn, sensitive and eczema prone skin. As such, these products need to be tested to evaluate their skin irritation and sensitization potential before use. The products were evaluated with two separate tests. The first test was conducted in a single-center, within-subject comparison using assessor-blind, randomised human skin irritation patch test (48 hour/96 hour exposure) and conducted on healthy adults with sensitive, atopic skin. The second test was conducted in a single-center, controlled (sterile water), within subject using human repeat-insult patch tests (HRIPTs) and conducted on healthy female Indonesian and Asian adult female subjects, with sensitive skin. The sensitization potential of each product was determined from International Contact Dermatitis Research Group (ICDRG) scores at 30 minutes, 24 hours, 48 hours and 72 hours after patch removal. Skin irritation tests show that all products were significantly lower than the positive control sodium lauryl sulphate (SLS) (p irritation scores at the respective time points. HRIPTs results show that Cussons Baby Sensicare Range was non-sensitizing. As such, it can be concluded that the Cussons Baby Sensicare Range tested is well tolerated on skin and has low skin irritation and sensitization potential. Thus, they can be considered hypoallergenic on sensitive skin and suitable for eczema prone skin.

关键词： Cussons Baby Sensicare Skin irritation Skin Sensitization Hypoallergenic HRIPT Atopic Skin Care Eczema Prone Skin Care

The extract of Mucuna pruriens possesses histamine activity

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Asian Pacific Journal of Tropical Medicine 2010年第1期3卷 29-31页

作者： Reginald NP Nwankwoala Georgewill OA Department of Pharmacology and Toxicology Faculty of Basic Medical SciencesUniversity of Port Harcourt

Objective:To investigate the activity of the active principle in the spines of the seed pods of Mucuna pruriens using contraction of guinea pig ileum as index of pharmacological activity. Methods:The active principle was extracted with 0.0015 M NaCl.Muscle strips of guinea pig ileum were prepared and contractile responses were measured using a Kymograph.Two sets of experiment were conducted:（1）.The contraction of the ileum in presence of different concentrations of histamine,2-methylhistamine and the extract of Mucuna pruriens.（2）.The contractile response of the ileum in presence of different concentrations of the extract and antagonists including diphenhydramine,atropine and methysergide.Results:（1） The extract of Mucuna pruriens hair, 2- methylhistamine and histamine produced dose dependent contraction of guinea pig ileum (Extract ED50 = 13.0μg/mL,2-methylhistamine ED50=8.5μg/mL and histamine ED50=10.0μg/ mL).（2） Diphenhydramine,an H,antagonist competitively blocked the contractile response of the Mucuna pruriens extract（3） Coadminstration of the Mucuna pruriens extract either with different doses of antimuscarinic agent atropine or 5-hydroxytryptamine blocking agent methysergide did not alter the extract induced contractile response of the guinea pig ileum.Conclusion:These results demonstrate that the spines of Mucuna pruriens possess histamine activity which may contribute to its itching and painful irritation effects.

关键词： Mucuna pruriens Histamine activity Itching irritation

Preparation and Characterization of Novel Drug-Inserted-Montmorillonite Chitosan Carriers for Ocular Drug Delivery

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Advances in Nanoparticles 2015年第3期4卷 70-84页

作者： Dongzhi Hou Ruyi Gui Sheng Hu Yi Huang Zuyong Feng Qineng Ping College of Pharmacy Guangdong Pharmaceutical University Guangzhou China School of Physics and Optoelectronic Engineering Guangdong University of Technology Guangzhou China College of Pharmacy China Pharmaceutical University Nanjing China

The objective of the study was to investigate the potential of montmorillonite as a sustained carrier in the preparation of drug-loaded nanoparticles for prolonged ocular application. Nanoparticles were prepared by ionic gelation of chitosan with sodium tripolyphosphate (TPP). Betaxolol hydrochloride (BH) was applied as a model drug. TG, FT-IR, TEM, DLS and XRD have been employed in the characterization of drug-encapsulated chitosan-montmorillonite/TPP nanoparticles (CS-MMT/TPP NPs). TEM images showed that the particles were spherical in shape and had a rough surface. The size range of the nanoparticles was between 338 and 585 nm with positive zeta potential values from 24 mV to 36 mV and encapsulation efficiency values ranging from 12.27% to 50.92%. In vitro sustained drug release was observed with the BH-loaded nanoparticles in artificial tears (pH 7.4). The results of FT-IR, TG and XRD showed that the drug was coated with CSMMT/ TPP NPs. In the mucoadhesion studies, an interaction was found between drug-loaded CSMMT/ TPP NPs and mucin, which could enhance precorneal residence time and hence facilitate an effective sustained release. The optimized formulation was determined to be non-irritant and tolerable by modified Draize test. Therefore, the BH-loading CS-MMT/TPP NPs developed are a promising carrier for controlled drug delivery to the eye.

关键词： Chitosan Montmorillonite Nanoparticles Mucoadhesive Sustained Release Ocular irritation

Safe Retinol-Like Skin Biological Effect by a New Complex, Enriched with Retinol Precursors

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Journal of Cosmetics, Dermatological Sciences and Applications 2020年第2期10卷 59-75页

作者： Ze’evi Ma’or Dror Cohen Ya’ara La’or-Costa Meital Portugal-Cohen Ahava Dead Sea Laboratories Lod Israel The Skin Research Institute the Dead-Sea and Arava Science Center Masada Israel

Background: Retinol (RE) is deeply involved in skin processes, therefore it is widely formulated in cosmetics, primarily as an anti-aging ingredient. Despite its efficacy, the safety profile of RE is controversial. Objectives: Pretinol (PRE) complex was formulated with two RE precursors, β-Carotene and Niacinamide, in order to deliver retinol-like skin benefits with healthier characteristics, assuming that skin enzymes will enable safe RE supply on spot. Methods: The expression levels of hyaluronic acid, Tumor Necrosis Factor alpha (TNFα) and Interleukin 1 alpha (IL-1α), were measured using various skin models before and after exposure to PRE and RE. Full genome microarray was performed and the affected genes and pathways were analyzed. Results: Following fibroblasts exposure to PRE, the natural synthesis of hyaluronic acid is significantly elevated. Skin safety, demonstrated via cytokines expression on ex-vivo skin, results with TNFα and IL-1α elevation by RE application. In contrary PRE significantly reduces TNFα while IL-1α is not affected. These results establish skin safety advantage of PRE vs RE. Microarray results examined on skin equivalents reveal the involvement of PRE in inflammatory attenuation. Conclusions: Formulating RE precursors as a safe source for RE is partially supported. PRE presents a skin benefit in parallel to RE, while PRE characteristics are suggested to be safer to skin.

关键词： Retinol Hyaluronic Acid β-Carotene Skin Inflammaging irritation

Sensitive Skin in China

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Journal of Cosmetics, Dermatological Sciences and Applications 2012年第3期2卷 184-195页

作者： Miranda A. Farage Christian P. Mandl Enzo Berardesca Howard I. Maibach Department of Dermatology University of San Francisco Medical School San Francisco USA San Gallicano Dermatological Institute Rome Italy The Procter & Gamble Company Schwalbach Germany The Procter & Gamble Company Winton Hill Business Center Cincinnati USA

Background: Many consumers in the USA and Europe define themselves as having sensitive skin, a phenomenon whose etiology appears to include both physiological and psychosocial factors. Objectives: Sensitive skin data from the developing world is sparse. This study evaluates the prevalence and characteristics of sensitive skin in China and compares data collected to existing data from the western world. Patients/Materials/Methods: A total of 408 Chinese women voluntarily completed a survey on sensitive skin. Results: Some degree of skin sensitivity was claimed by 94 (23%) of respondents;most (90.4%) said their skin was only slightly or moderately sensitive. Facial sensitivity was claimed by 21% of Chinese women, sensitivity of the body surface by 9% and genital sensitivity by only 6%. Small numbers of respondents reported a history of skin allergy (3%) or a familial history of sensitive skin (2%). Many reported making buying decisions based on product claims. Conclusions: Only 23% of Chinese women claimed any degree of sensitive skin, a prevalence substantially lower than that observed in most Western countries. Sensitivity of the genital skin, in particular, was dramatically lower, suggesting at least some cultural component to perceptions of sensitive skin.

关键词： Sensitive Skin Genital Skin irritation Skin Sensitivity Stinging Erythema Feminine Hygiene Fabrics Sensory

The Dual Positive Actions of Colonic Release of Ibuprofen in TNBS-Induced Colitis Wistar Rats

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Journal of Biomedical Science and Engineering 2014年第8期7卷 573-583页

作者： Heni Rachmawati Anastasia I Ketut Adnyana Kusnandar Anggadiredja School of Pharmacy Bandung Institute of Technology Bandung Indonesia

Ibuprofen is a relatively safe anti inflammatory drug among other NSAIDs. However, frequent and long-term administration of ibuprofen in conventional oral preparation is still considered for ulceration. As previously reported, the daily administration of the ibuprofen orally for 14 days in rats caused the gastroduodenal ulcer. Several mechanisms have been reported: the suppression of the gastric prostaglandin synthesis and the local irritant effect on epithelium due to the direct contact of drug with mucosal wall. In this work, developed ibuprofen pellet with double coatings aimed to release ibuprofen only when reaching colonic compartment. The results of pharmacokinetic study reported previously suggested that this might be a successful target. Present study described the potential benefits of this formula in exhibiting effective local anti inflammatory action in colon. Male Wistar rats were induced for ulcerative colitis with 2,4,6-trinitrobenzene sulfonic acid. Twenty four hours after induction, treatments were given using either ibuprofen suspension or pellet for 14 days. Ulcerations were observed visually, with gross anatomic and microscopic examinations. Group treated with ibuprofen pellet showed best recovery nearly close to healthy group. Moreover, the group did not develop ulceration in upper part of GIT. Colonic targeted ibuprofen pellet showed most effective local antiinflammatory action and at the same time reduced the ulcer formation in the upper part of GIT.

关键词： Colonic Release Ibuprofen TNBS-Induced Colitis Gastrointestinal Ulcer Non-Steroid Anti-Inflammatory Drugs Topical irritation