T/CNLIC0224－2025 中国轻工业联合会 团体标准 化妆品功效人体测试 基于双光子在体显微成像技术的测试方法 T/CNLIC0224－2025 * 中国轻工业出版社出版发行 地址：北京鲁谷东街5号 邮政编码：100040 发行电话：(010)85119832 网址：http://www.chlip.com.cn Email：[email protected] 轻工业标准化研究所编辑 地址：北京西城区月坛北小街6号院 邮政编码：100037 电话：(010)68049923 * 版权所有侵权必究 书号：155019·7205 印数：1－200册定价：30.00元 全国团体标准信息平台 2025-12-26发布 2025-12-26实施 中国轻工业联合会发布ICS11.040.99 CCSC30 团 体 标 准 T/CNLIC0224－2025 化妆品功效人体测试 基于双光子在体显微成像技术的测试方法 Humantestingforcosmeticefficacy— Testmethodbasedontwo-photoninvivomicroimagingtechnology 全国团体标准信息平台 T/CNLIC0224－2025 I目次 前言······························································································································II 1范围····························································································································1 2规范性引用文件···········································································································1 3术语和定义·················································································································1 4基本要求····················································································································2 5测试原理····················································································································2 6受试者的选择··············································································································3 7测试方法····················································································································3 8数据统计····················································································································5 9结果应用····················································································································5 10试验报告···················································································································5 附录A（资料性）测试仪器运行参数·················································································6 附录B（资料性）皮肤结构图像的标准示例········································································7 附录C（资料性）测试指标与结果评估对照········································································9 参考文献·······················································································································10 全国团体标准信息平台 T/CNLIC0224－2025 II前言 本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规定 起草。 请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。 本文件由中国轻工业联合会提出并归口。 本文件起草单位：欧诗漫生物股份有限公司、北京颐唯实检测技术有限公司、山西锦波生物医药股 份有限公司、诺斯贝尔化妆品股份有限公司、上海家化联合股份有限公司、杭州希科检测技术有限公司、 华测检测认证集团股份有限公司、上海微谱检测科技集团有限公司、北京超维景生物科技有限公司、北 京金宏帆商贸有限责任公司。 本文件主要起草人：赵瑞丽、范莹、刘琦、冯子然、陈传秀，周大为、邱晓锋、彭心宇、陈默、 闫昕宇、王晓、李玉洁、陈映格、王思艺、崔俭杰、刘玉、王俊杰、王芳。 全国团体标准信息平台 T/CNLIC0224－2025 1化妆品功效人体测试 基于双光子在体显微成像技术的测试方法 1范围 本文件描述了化妆品功效人体测试中基于双光子在体显微成像技术的测试方法。 本文件适用于化妆品功效人体测试中采用双光子在体显微成像技术开展测试的方法。其他研究领域 基于双光子在体显微成像技术的测试方法参照执行。 2规范性引用文件 下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文件， 仅该日期对应的版本适用于本文件：不注日期的引用文件，其最新版本（包括所有的修改单）适用于本 文件。 《化妆品安全技术规范》（2015版）（国家食品药品监督管理总局2015年第268号） 3术语和定义 下列术语和定义适用于本文件。 3.1 双光子显微成像two-photonmicroscopy 利用聚焦近红外飞秒激光作用于皮肤，从而激发皮肤组织中的双光子荧光信号及二次谐波信号的在 体显微成像技术。 3.2 荧光通道投影面积fluorescentchannelprojectionareavalue 皮肤中弹性纤维荧光信号的分割投影面积。 注1：皮肤中弹性纤维是由弹性蛋白和微原纤维组成的结缔组织纤维，是真皮中的一种重要纤维。在真皮乳头内， 弹性纤维呈垂直方向生长直至真表皮交界处，进入到真皮网状层浅层后，其排列与胶原纤维平行或斜行。弹 性纤维在吸收适当波长的光子后，会发生自发发射荧光的现象。其荧光信号由该通道输出，输出深度一般为 80μm～120μm（不同测试部位和人群略有不同）。 注2：此值表征测试区域内真皮浅层弹性纤维的分布密度。此值越大，说明测试区域的弹性纤维分布密度越高，弹 性纤维含量越高；反之则越低。 注3：此值无量纲。 3.3 谐波通道投影面积harmonicchannelprojectionareavalue 皮肤中胶原纤维二次谐波信号的分割投影面积。 注1：皮肤中胶原纤维是真皮中的主要结缔组织纤维，主要由I型胶原构成（少数为Ⅲ型胶原），经多级拓扑结构 组装成束，排列紧密且交织成网，因对光产生强烈米氏散射而呈现白色；在真皮层内，胶原纤维主要分布于 网状层，部分延伸至乳头层，排列方向与皮肤张力方向一致，承担皮肤支撑、抵抗拉力的核心功能。在聚焦 全国团体标准信息平台 T/CNLIC0224－2025 2飞秒激光作用下，胶原纤维会发生非线性光学现象—产生二次谐波信号（频率为入射光频率两倍、波长为入 射光波长一半），该信号由谐波通道输出，输出深度一般为80μm～120μm（不同测试部位和人群略有不同）。 注2：此值表征测试区域内真皮浅层胶原纤维的分布密度。此值越大，说明测试区域的胶原纤维分布密度越高，胶 原纤维含量越高；反之越低。 注3：此值无量纲。 3.4 表皮厚度epidermalthickness 皮肤表面至真表皮交界的平均深度。 注1：此值越大，说明测试区域的表皮越厚；反之则越小。 注2：单位为微米（μm）。 3.5 真表皮交界标准化面积dermal-epidermaljunctionindex;DEJI 皮肤真表皮交界的表面积与其沿皮肤表面法线方向的投影面积之比。 注1：此值越大