新旧化妆品检验规范的对比及对化妆品审评的影响

目的： 全面解读2019年9月10日国家药品监督管理局发布的《化妆品注册和备案检验工作规范》，为开展化妆品审评提供参考。方法： 从多个方面对比已实施的《化妆品注册和备案检验工作规范》和同步废止的《化妆品行政许可检验规范》，分析二者的不同之处对化妆品审评可能带来的影响，并对今后的工作方向提出预见和建议。结果： 《化妆品注册和备案检验工作规范》取消了现行的由药品监管部门对化妆品注册和备案检验检测机构进行资格认定和指定，允许社会优质资源承担化妆品注册和备案检验工作，并对检验工作流程进行了优化，对检验项目要求进行了调整和规范。结论： 《化妆品注册和备案检验工作规范》的发布和实施，对化妆品注册和备案检验以及化妆品审评工作都提出了新的要求，相关部门应尽快适应。     

Guide for medical professionals (i.e. dermatologists) for the management of Rhododenol‐induced leukoderma

Because some users develop depigmentation after the use of melanogenesis‐inhibiting products containing the quasi‐drug ingredient Rhododenol, Japanese Dermatological Association (JDA) established a Special Committee on the Safety of Cosmetics Containing Rhododenol on July 17, 2013 and management guide for dermatologists has been updated on the website in order to delineate the diagnostic criteria for Rhododenol‐induced leukoderma and provides a broad guide for standard treatment based on current knowledge. This guide is produced on the basis of the guide (version 7) updated on June 20, 2014 in the website. Rhododenol‐induced leukoderma refers to depigmentation of varying severity that develops after the use of cosmetics containing Rhododenol, mainly at the site of use. In most cases, repigmentation of part or all the affected area is evident after discontinuation. Histopathologically cellular infiltration around the hair follicles and melanophages are present in most cases. The number of melanocytes in the lesion is declined but not totally absent in most cases. Rhododenol itself is a good substrate for tyrosinase, resulting in the formation of Rhododenol metabolites (e.g., Rhododenol quinone). Melanocytes are damaged by Rhododenol metabolites during the subsequent metabolic process. The continued use of cosmetics containing Rhododenol thus induces tyrosinase activity‐dependent cytotoxicity in melanocytes in the epidermis at application sites, resulting in decreasing the amount of melanin produced by melanocytes; the addition of some other factor to this process is believed to subsequently cause the decrease or disappearance of melanocytes themselves from the epidermis.     

“药妆品”全球监管情况以及对我国的启示

目的：梳理全球范围内"药妆品"监管情况，并对我国政府监管和行业发展提出建议。方法：选取化妆品生产和消费的主要国家或地区作为研究对象，如欧盟、美国、日本、韩国、加拿大等。通过对我国以及上述国家或地区的化妆品定义、相关产品分类、是否承认"药妆品"等情况进行研究比对，对其中容易造成错误理解的概念进行阐释，结合近年来相关问题的监管手段及监管趋势进行分析，总结出适合我国国情的监管建议。结果：通过研究比对，"药妆品"概念不符合大多数国家或地区关于"化妆品"的定义及相关法规要求，监管部门对此持相对谨慎态度，并采取了多种监管手段。结论："药妆品"在全球范围内基本不具有合法地位，我国监管部门应继续保持打击力度，加强上市后监督检查；同时，进一步规范产品分类和功效宣称，积极引导整个行业长期健康发展。     

Tier-based skin irritation testing of hair cleansing conditioners and their constituents

Purpose/Aim: The U.S. Food and Drug Administration (FDA) does not require specific testing to demonstrate the safety of personal care and cosmetic products or their ingredients. Recently, there have been reports of skin irritation associated with the use of commercially available cleansing conditioners. The goal of this study was to implement a tier-based safety assessment to evaluate the skin irritation potential of six commercially available cleansing conditioners and their ingredients.

Materials and Methods: The first tier of testing utilized the Organization for Economic Co-operation and Development (OECD) QSAR Toolbox to perform an in silico evaluation of the skin irritation potential of the product ingredients, and the second tier of testing utilized an OECD in vitro guideline test to evaluate the skin irritation potential of each product.

Results: Thirty-two ingredients were evaluated using the OECD QSAR Toolbox profiler for the tier one analysis; nine ingredients received a structural alert for skin irritation/corrosion. In the tier two in vitro analysis, the evaluated cleansing conditioner products were all classified as non-irritants.

Conclusions: These results provide evidence that use of the evaluated commercially available cleansing conditioners would not be expected to cause skin irritation among consumers. Additionally, this study demonstrates that the presence of structural alerts does not always accurately predict the safety of a product, as focused tier-based testing is necessary to comprehensively evaluate a product. This study illustrates a tier-based safety assessment approach, applicable to a wide variety of health endpoints, which efficiently and adequately evaluates the safety of personal care and cosmetic products and their ingredients.     

纳米氧化锌安全性评价及化妆品法规管理现状

目的：了解国内外纳米氧化锌安全性评价及化妆品法规管理现状,为我国对纳米原料与纳米化妆品监管提供参考。方法：通过文献研究,总结目前国内外纳米氧化锌的毒理学研究进展及世界主要国家及地区对纳米氧化锌的化妆品法规管理现状。结果：透皮吸收试验发现防晒霜中的纳米氧化锌主要聚集在人体皮肤角质层和毛囊皮脂腺开口处,微量锌可经皮肤吸收进入血液,但不能确定是以氧化锌还是锌离子的形式吸收。体外彗星试验结果显示纳米氧化锌引起人表皮细胞、人鼻粘膜细胞DNA损伤。亚急性经口毒性试验发现纳米氧化锌通过氧化应激介导小鼠肝脏细胞DNA损伤和凋亡。纳米氧化锌对小鼠具有生殖发育毒性。急性吸入毒性试验显示纳米氧化锌导致大鼠肺脏、肝脏组织损伤。亚慢性毒性试验显示纳米氧化锌高剂量组（536.8 mg·kg^-1）SD大鼠出现贫血及轻度到中度胰腺炎,纳米氧化锌的未观察到有害作用水平（NOAEL）为268.4 mg·kg^-1。欧盟、美国、中国台湾已出台了一系列化妆品纳米材料的法规或文件,指导化妆品行业开展纳米材料的安全性评价。结论：化妆品中纳米氧化锌对人体具有潜在安全风险,我国应尽快制定化妆品中纳米原料的相关管理政策。     

HPLC同时测定化妆品中22种香豆素类化合物及质谱确证

目的 建立同时测定化妆品中22种香豆素类化合物的HPLC及液相色谱-串联质谱验证方法。方法 采用Agilent Eclipse XDB-Phenyl色谱柱(150 mm×4.6 mm,3.5μm),流动相为乙腈-0.1%磷酸,梯度洗脱,流速为1.0 mL·min^–1,柱温为35℃,检测波长分别为227,310 nm。以HPLC结果进行定性筛查,并采用标准曲线法定量,以液相色谱-串联质谱法的结果进行确证。结果 22种香豆素类化合物的线性范围为0.1～10 mg·L^–1,相关系数均>0.999 3,方法检出浓度为0.1～1.5 mg·kg^–1,在低、中、高3种加标水平下,平均回收率为91.4%～114.8%,RSD为0.1%～4.8%。结论 该方法操作简便、准确,适用于膏乳、水剂、粉类及精油类化妆品中22种香豆素类化合物的检测。     

化妆品毒理学试验方法的标准比对(Ⅱ)

《化妆品新原料注册备案资料管理规定》对化妆品新原料进行了分类管理,制订了系统、详实的新原料注册/备案资料清单。本文对此进行梳理,并比较了国内外急性经口毒性试验、亚慢性经口毒性试验和慢性毒性/致癌性结合试验标准,对现有的化妆品标准提出意见和建议。     

化妆品中常用中草药原料研究进展

现今世界化妆品的发展趋势是倡导绿色、天然、环保和安全,且追求功效。近年来,以作用温和,刺激性小,安全性高的中草药提取物作为添加剂,应用于化妆品中已经成为新产品开发的热点。该文从化妆品中草药原料的主要功能分类,对应用于化妆品的常用中草药原料进行综述,为今后开发常用中草药的化妆品提供参考依据。