潜在内分泌干扰风险防晒剂的监管及其使用情况分析

欧盟对具有潜在内分泌干扰风险的化妆品原料进行筛查并建立了化妆品原料优先评估清单,该清单包含了4个欧盟化妆品指令准用防晒剂。文章以优先评估清单中的防晒剂为研究对象,对其在欧盟、美国等国家(地区)的监管情况和在我国的使用情况进行概述和分析,并汇总欧盟消费者安全科学委员会的再评估结果。经研究调查发现,优先评估清单中防晒剂在我国的法规限值与美国、日本和韩国规定基本一致,但部分防晒剂限值较欧盟新修订限值高,可能存在安全风险。建议监管部门综合评估上述防晒剂的安全风险、实际使用情况和行业发展等因素,通过进一步评估和细化法规限值,以期更好地保障民众用妆安全。

2017—2021年我国进口防晒化妆品注册情况分析

通过查询国家药监局网站公布的化妆品批件信息,对2017—2021年我国进口防晒化妆品的批件数量、原产国、紫外线防御能力、剂型和配方中防晒剂等数据进行归纳、整理和分析。结果显示:2017—2021年五年间,我国共发放进口防晒化妆品批件3 057件,韩国是进口防晒化妆品的最大原产国;紫外线防御能力方面,SPF值未见明显增长,高PFA值产品占比有明显提高;进口防晒化妆品主要剂型为膏霜乳,喷雾剂有逐渐增加的趋势;产品配方中使用频率最高的防晒剂是安全系数相对较高的甲氧基肉桂酸乙基己酯。针对上述分析结果,结合文献报道、法规监管和社会热点等方面内容,进一步剖析以期全方位了解我国进口防晒化妆品情况,为我国化妆品市场监管和国内化妆品企业研发提供有益的借鉴和参考。

A biomimetic nanoplatform for customized photothermal therapy of HNSCC evaluated on patient-derived xenograft models

Cancer cell membrane(CCM)derived nanotechnology functionalizes nanoparticles(NPs)to recognize homologous cells,exhibiting translational potential in accurate tumor therapy.However,these nanoplatforms are majorly generated from fixed cell lines and are typically evaluated in cell line-derived subcutaneous-xenografts(CDX),ignoring the tumor heterogeneity and differentiation from inter-and intra-individuals and microenvironments between heterotopic-and orthotopic-tumors,limiting the therapeutic efficiency of such nanoplatforms.Herein,various biomimetic nanoplatforms(CCM-modified gold@Carbon,i.e.,Au@C-CCM)were fabricated by coating CCMs of head and neck squamous cell carcinoma(HNSCC)cell lines and patient-derived cells on the surface of Au@C NP.The generated Au@C-CCMs were evaluated on corresponding CDX,tongue orthotopic xenograft(TOX),immunecompetent primary and distant tumor models,and patient-derived xenograft(PDX)models.The Au@C-CCM generates a photothermal conversion efficiency up to 44.2% for primary HNSCC therapy and induced immunotherapy to inhibit metastasis via photothermal therapy-induced immunogenic cell death.The homologous CCM endowed the nanoplatforms with optimal targeting properties for the highest therapeutic efficiency,far above those with mismatched CCMs,resulting in distinct tumor ablation and tumor growth inhibition in all four models.This work reinforces the feasibility of biomimetic NPs combining modular designed CMs and functional cores for customized treatment of HNSCC,can be further extended to other malignant tumors therapy.

喷雾型防晒化妆品的国际法规动态和技术监管讨论

分析了我国喷雾型防晒化妆品的发展趋势,综述了欧盟、美国、澳大利亚、韩国等国家和地区的监管动态和法规要求,对此类产品的原料使用和生产工艺、理化检验、毒理学试验、防晒功效测试、产品安全评估、使用方法和标签管理等相关技术要点进行了分析和讨论,并提出了监管建议,对喷雾型防晒化妆品在监管科学下的精细化管理进行了总结和展望。

Self-erasable dynamic surface patterns via controllable elastic modulus boosting multi-encoded and tamper-proof information storage

Dynamic surface patterns(DSPs)have attracted significant interest in anti-counterfeiting,enabling information to be stored,encrypted and decrypted in response to external stimuli.However,creating dynamic surface patterns,capable of controlling wrinkling time and independently modulating different information in both wrinkled and fluorescent states,remains a tremendous challenge.These limit DSPs to further enhance tamper-proofing capacity and extend the information storage density.Here,a rationally designed patterning strategy based on controllable elastic modulus was demonstrated to fabricate self-erasable dynamic surface patterns(S-DSPs)that increase information storage density.These novel S-DSPs strategically integrated amino co-oligomers(ACOs)with the 9-anthracenemethanol(9-AM)as skin layers,designing a bilayer multi-encoding system which could carry several different types of information with wrinkled and fluorescent patterns.The ACOs with relatively low molecular weight can endow the elastic modulus of skin layers with a wide range of regulation.As a result,the difference between the compressive strain and the critical wrinkle strain in the bilayer system would be precisely modulated by photo-dimerization to form quick-response(minimum<1 min)and self-erasable(3 min–8 days)wrinkled patterns for S-DSPs.Meanwhile,the fluorescence pattern could be independently erased and reprogrammed without affecting the change in the wrinkle pattern under modulus-controlled conditions.Moreover,controllable self-erasure in S-DSPs significantly develops tamper-proof capabilities in a supply chain.This original strategy could provide a new approach to the tamper-proof,high-density,and multi-encoded information storage in the product security or inkless printing.

Clinical utility of PDX cohorts to reveal biomarkers of intrinsic resistance and clonal architecture changes underlying acquired resistance to cetuximab in HNSCC

Cetuximab is a widely used drug for treating head and neck squamous cell carcinomas(HNSCCs);however,it provides restricted clinical benefits,and its response duration is limited by drug resistance.Here,we conducted randomized“Phase II-like clinical trials”of 49 HNSCC PDX models and reveal multiple informative biomarkers for intrinsic resistance to cetuximab(e.g.,amplification of ANKH,up-regulation of PARP3).After validating these intrinsic resistance biomarkers in another HNSCC PDX cohort(61 PDX models),we generated acquired cetuximab resistance PDX models and analyzed them to uncover resistance mechanisms.Whole exome sequencing and transcriptome sequencing revealed diverse patterns of clonal selection in acquired resistant PDXs,including the emergence of subclones with strongly activated RAS/MAPK.Extending these insights,we show that a combination of a RAC1/RAC3 dual-target inhibitor and cetuximab could overcome acquired cetuximab resistance in vitro and in vivo.Beyond revealing intrinsic resistance biomarkers,our PDX-based study shows how clonal architecture changes underlying acquired resistance can be targeted to expand the therapeutic utility of this important drug to more HNSCC patients.