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1 植物原料在化妆品中的应用及其安全性分析 Application and Safety Analysis of Plants in Cosmetic Products 石钺 Shi Yue 1

2 概述 Introduction 现今世界化妆品的发展趋势是倡导绿色环保和安全, 且追求功效因此, 近十多年来, 以作用温和又具有一定功效的中草药提取物作为天然物添加剂, 应用于化妆品中已经成为新产品开发的热点中草药因其独特机理和美容效果已被广泛应用于护肤类化妆品中, 但是对于发现和评价植物提取物护肤品的有用性与安全性, 一直是美容应用技术理论与技术研发所面临的热点课题 2

3 化妆品的定义及一般要求 Definition and General requirements of Cosmetic Product 化妆品 (cosmetics) 是指以涂擦喷洒或者其他类似的方法, 散布于人体表面任何部位, 如皮肤毛发指甲口唇等, 以达到清洁清除不良气味护肤美容和修饰目的的日用化学品 Cosmetics, in China, are defined as chemical products for daily use that can be placed in contact with the external parts of human body (epidermis, hair system, nails, lips etc.) with the purpose of cleaning, correcting body odors, skin care, beauty treatment and changing appearance. 3

4 化妆品的定义及一般要求 Definition and General requirements of Cosmetic Product 化妆品在正常以及合理的可预见的使用条件下, 不得对人体健康产生危害 Cosmetics, under normal, reasonably foreseeable condition of use, will not cause harm or damage to human heath. 在中国, 化妆品包括 : 非特殊用途化妆品和特殊用途化妆品从法律法规层面来讲, 没有药妆品功能性化妆品中药化妆品等概念 In China, cosmetics include two categories non-special use cosmetics and special cosmetics. From a legal perspective, there are not concepts such as pharma-cosmetics, functional cosmetics, Chinese-medicine cosmetics etc. 4

5 植物原料应用现状 Current Situation of Plants Used to Cosmetic Products 天然植物作为化妆品的主要来源和基础原料由来久远, 在中国, 天然植物的应用是沿用了中草药美容的概念, 中草药在保健美容方面的应用已有三千年的历史 There is a long history of using natural plants/natural ingredients/plant extracts as the main source and basic ingredient for cosmetics. In China, the application of natural plants, following the concept of Chinese herbal beauty treatment, has a history of over 3000 years in beauty enhancement and health care. 5

6 植物原料应用现状 Current Situation of Plants Used to Cosmetic Products 传统的应用实践已积累了许多功效记录和经验, 对它们的用量安全性和副作用也有许多验证, 为化妆品的原料探寻开辟了广阔的资源并对新型化妆品的开发提供了有利的条件, 具有很强的优势和广阔的应用前景 The traditional application has gained extensive experience and performance records, as well as verifications regarding the usage amounts, safety and side effects. This provides advantages in future development of new cosmetic products and wide resources for ingredient exploration. 6

7 植物原料应用现状 Current Situation of Plants Used to Cosmetic Products 植物提取物在化妆品中的作用是多方面的, 主要应用于护肤护发植物精油等化妆品中 Plant extracts in Cosmetics have wide applications, mainly in skin care, hair care, essential oils etc. 7

8 植物原料应用现状 Current Situation of Plants Used to Cosmetic Products 在护肤品中, 具有抗氧化抗衰老美白保湿等作用 In skin care products, natural plants have effects in anti-oxidation, antiaging, skin whitening and moisturizing etc. 在头发护理方面, 具有改善头部皮肤功能促进头发生长减少头皮屑等作用 In hair care products, plants can improve scalp skin s health, promote hair growth and reduce dandruff. 芳香植物精油, 气味芳香, 具有愉悦心灵安抚皮肤等作用, 在化妆品芳疗产品中得到广泛应用 Essential Oils have a fragrant smell calm the heart and sooth skin. Aromatherapy products are therefore widely used. 8

9 植物原料应用现状 Current Situation of Plants Used to Cosmetic Products 目前, 研究最多的是具有抗氧化作用的植物成分, 如来源于甘草的甘草次酸, 来源于牡丹等的丹皮酚, 来源于阿魏等的阿魏酸, 等等 Firstly, most current researches focus on the antioxidant id t effect of fbotanical ingredients, such as glycyrrhetinic acid from Licorice, paeonol from Peony and ferulic acid from Ferula, etc. 其次, 从药用植物中提取的天然的酶抑制剂近年来也被人们广泛注意, 如熊果提取物具有酪氨酸酶抑制作用, 薏苡仁提取物具有较强的透明质酸酶抑制作用, 杏仁提取物对胶原酶有抑制作用, 等等 Secondly, natural enzyme inhibitors extracted from medicinal plants have also attracted increasing attention over the past few years, such as bearberry extract with a tyrosinase inhibition, Coix seed extract with a strong hyaluronidase inhibition and almond extract with a collagenase inhibition etc. 9

10 植物原料应用现状 Current Situation of Plants Used to Cosmetic Products 此外, 还有很多应用于化妆品的药用植物, 这些植物的提取物成分复杂作用机制多种多样, 同时存在广泛的相互作用 In addition, for many herbal medicines widely used in cosmetics, their extracts have complex compositions, varied working mechanisms and widespread interactions. 10

11 植物原料在化妆品中的应用 Plant Extracts in Cosmetic Products 11

12 植物原料在化妆品中的应用 Plant Extracts in Cosmetic Products 12

13 植物原料在化妆品在的应用形式 Application forms of Natural Plants in Cosmetics 天然植物在化妆品中的应用形式大体可分为三类 : Natural plant applications in cosmetics can roughly be divided into 3 categories: 单一化学成分 : 化学结构清楚, 功效明确, 安全性资料比较全面, 如鞣花酸, 熊果苷, 阿魏酸等在护肤品中可起到多重作用, 如抗氧化抗衰老防晒美白保湿等作用 Single Chemical Composition: with clear chemical structures, t effectiveness and comprehensive safety data, such as ellagic acid, arbutin and ferulic acid etc. They can play multiple roles in skincare products, such as anti-oxidation, anti-aging, sun protection, skin whitening and moisturizing etc. 13

14 植物原料在化妆品在的应用形式 Application forms of Natural Plants in Cosmetics 多组分混合物 : 化学结构类型相对明确, 大多有定量控制指标, 如甘草黄酮, 人参皂苷, 多酚类, 甾醇类, 多糖类, 植物蛋白等 Multiple Chemical Composition: with relatively clear chemical structures and quantitative control index, such as licorice flavonoids, ginseng saponins, polyphenols, sterols, polysaccharides and plant protein etc. 植物提取物 : 一般由水或醇提取而得的浸膏粉或流浸膏, 一般有定量控制指标, 如积雪草提取物, 芦荟叶汁 Plant Extract: generally extract powder or fluid extract extracted by water or ethanol and in general with quantitative control index, such as Centella asiatica extract and aloe leaf juice. 14

15 植物原料在化妆品在的应用形式 Application forms of Natural Plants in Cosmetics 对于植物提取物来讲, 最大问题 : 一是提取物的质量稳定性可控性和均一性 ; 二是工艺的可重复性和可控制性 ; 三是功效的可评价性和安全性 For the plant extract concerned, its biggest problems are: firstly, stability, controllability and uniformity of extract quality; secondly, repeatability and controllability of process; thirdly, evaluation and safety of effectiveness. 15

16 植物原料的安全性分析 Safety of Plants in Cosmetics 植物原料在化妆品中的应用广泛, 然而, 实际上大多数植物从严格意义上讲, 都没有进行过安全性有效性及质量的评估, 更没有深入了解这些植物成分的透皮吸收及与皮肤的作用机制, 所谓的天然化妆品依然可能存在一定的安全隐患 Plant extracts are widely used in cosmetics. However, strictly speaking, many have not thoroughly hl undergone safety and quality assessment, and lack an in-depth understanding of percutaneous absorption of these extracts and their interaction mechanisms with skin. Therefore, so-called natural cosmetics may still hold some safety risks. 16

17 植物原料的安全性分析 Safety of Plants in Cosmetics 为规范化妆品原料的使用,2003 年经中国卫生部批准使用了的已使用化妆品成分名单中列出植物原料 ( 含中药 ) 计 563 多种 To regulate the usage of cosmetic ingredient, thelistofusedcosmetics Component approved by the Ministry of Health in 2003 lists more than 563 plant based raw materials (including Chinese medicines) 年版国际化妆品原料标准中文名称目录, 共收录种原料, 其中 1/3 以上是植物性原料 The Catalogue of Standard Chinese Name of International Cosmetic Ingredient (2010 Edition) contains raw materials, of which 1/3 are plant based. 17

18 植物原料的安全性分析 Safety of Plants in Cosmetics 需要注意的是, 国际化妆品原料标准中文名称目录不能作为在中国化妆品中可使用原料的依据 Note: The Catalogue of Standard Chinese Name of International Cosmetic Ingredient can not be the reference for permitted cosmetic raw materials in China. 化妆品卫生规范中禁用植物原料有 78 种, 禁用的植物性来源的单一成分约 90 余种如 : 细辛, 白芷, 补骨脂 ; 欧前胡内酯, 石榴皮碱, 无花果净油等 There are 78 natural plants and approximate 90 plants with single chemical composition prohibited in cosmetics hygiene regulation, such as Asarum sieboldi, Angelica dahurica, Psoralea corylifolia, imperatorin, pelletierine and fig leaf absolute etc. 18

19 植物原料的安全性分析 Safety of Plants in Cosmetics 植物原料可能带来的安全性风险问题主要分为两个方面 : Safety risks of natural plants mainly are divided into two aspects: 外来因素 : 重金属农药残留溶剂残留合成树脂单体的残留 External: heavy metals, pesticide residues, solvent residues, monomer of synthetic resin residues 内在因素 : 可能含有的风险成分 Internal: possible risks contained in plants 19

20 植物原料的安全性分析 Safety of Plants in Cosmetics 对于外来因素, 可以通过一定的技术手段, 最大限度地降低安全风险然而, 对于内在因素, 就目前的技术水平, 难以有效控制 For external factors, safety risks can be minimized through certain technology. However, in terms of Internal factors, the effectively control of safety risks is very difficult at current level of science and technology. 20

21 植物原料的安全性分析 Safety of Plants in Cosmetics 植物中含有众多的化学成分, 其中很可能含有技术上不可避免的风险成分, 正是这些成分的存在而造成植物原料使用的潜在风险, 如 : 石榴皮中的石榴皮碱肉豆蔻中的黄樟醚蛇床子中的欧前胡内酯延榴皮碱胡索中的北美黄连碱等尽管单体成分已列入禁用的清单, 但对于这些植物原料的应用, 是否会带来安全隐患, 应开展相应的安全性风险评估 There are many chemical components in natural plants. It very likely to have technically unavoidable risky components, which cause the potential risks in the usage of natural plants in cosmetic products, such as pelletierine in Punica granatum bark, safrole in Myristica fragrans, imperatorin in Cnidium monnieri, hydrastine in Corydalis yanhusuo, etc. Although single compounds have been prohibited, whether applications of the these plants will cause potential safety hazard should undergo safety risk assessment. 21

22 植物原料的安全性分析 Safety of Plants in Cosmetics 如何检测化妆品中具有安全隐患的植物原料 How to detect a natural plant with potential safety risk? 如何对植物原料进行安全性风险评估 How to implement safety risk assessment to natural plants? 22

23 化妆品中补骨脂的检测 Identification of Psoraleae fructus in cosmetics 补骨脂由于具有光化学毒性, 化妆品卫生规范 (2007 年版 ) 规定了补骨脂禁止使用在化妆品中 Psoraleae fructus was a prohibited plant in cosmetics due to its phototoxicity in Cosmetics Hygiene Regulation (2007 Edition) in China. 参照指纹图谱的研究方法, 运用高效液相色谱法对化妆品中的补骨脂进行定性鉴别 According to a method of fingerprint chromatography, Psoraleae fructus in cosmetics can be qualitatively analyzed by HPLC. 23

24 化妆品中补骨脂的检测 Identification of Psoraleae fructus in cosmetics 中药指纹图谱赖以鉴别中药的药材真伪和质量优劣, 强调的是药用植物物种的共有特征性, 因此, 利用中药药用化学成分色谱是完全可以对药材不同种属进行鉴别 The fingerprint of medicinal herbs stress mutual characteristics of medicinal plant species in identification of the authenticity and distinguishing the quality; therefore, identification of different species of medicinal herbs were entirely feasible by HPLC fingerprint. 24

25 化妆品中补骨脂的定性检测 Identification of Psoraleae fructus in cosmetics 补骨脂的共有成分 : 香豆素类成分 ( 如补骨脂素和异补骨脂素 ), 黄酮类成分 ( 如新补骨脂异黄酮和补骨脂二氢黄酮 ) The fingerprint analysis of Psoraleae fructus from different sources showed that mutual characteristics of Psoraleae fructus include not only furanocoumarins (psoralen and isopsoralen), but also flavonoids (neobavaisoflavone and bavachin). 不同来源及不同提取方式时补骨脂所含化学成分量会有一定差异, 但包括补骨脂素和异补骨脂素在内的特征峰均会以高含量检出因此通过对特征峰的定性检测, 可以鉴别补骨脂的存在 Researches show that characteristic peak of psoralen and isopsoranlen will be identified with high concentration regardless of sources, extracting methods and resulted composition difference. Therefore, qualitative analysis of these two can preliminarily identify Psoraleae fructus. 25

26 mau 120 DAD1 A, Sig=246,4 4 Ref=off ff (D:\LC DATA...5\HZPIN BGZHI-SAMPLES \STD-10UG-ML.D) 09 04\STD D) min peak 1: psoralen peak 2: isopsoralen peak 3: neobavaisoflavone peak 4: bavachin Mix stsndsrds mau DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...ZPIN SANDEN-CHUNGAO \DUIZHAOYAOCAI.D) min Psoraleae fructus 26

27 DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...1\HZPIN SANDEN-CHUNGAO \YAOCAI-TRT.D) mau min 同仁堂 mau DAD1 A, Sig=246,4 Ref=off (D:\LC DATA SANDEN-CHUNGAO \YAOCAI-ANKANGTANG.D) 安康堂 min mau DAD1 A, Sig=246,4 Ref=off (D:\LC DATA SANDEN-CHUNGAO \YAOCAI-HONGSHENGTANG.D) 宏生堂 min 27

28 9 mau DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...ZPIN SANDEN-CHUNGAO \XIANGYIBENCAO.D) mau DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...28-SANDEN-CHUNGAO \RJ-XYBC-YAOCAI-20XISHI-3.D) mau DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...1\HZPIN SANDEN-CHUNGAO \XINGFUSHUI.D) min min DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...-SANDEN-CHUNGAO \RJ-XFSHUI-YAOCAI-20XISHI-3.D) mau 精华乳 + 补骨脂 Whitening emulsion + Psoraleae fructus min min 醒肤水 + 补骨脂 Toner + Psoraleae fructus DAD1 A, Sig=246,4 Ref=off (D:\LC DATA \HZPIN SANDEN-CHUNGAO \SANFEN.D) DAD1 A, Sig=246,4 Ref=off (D:\LC DATA...-SANDEN-CHUNGAO \RJ-SANFEN-YAOCAI-20XISHI-4.D) mau mau min min 蜜粉 + 补骨脂 Face Powder + Psoraleae fructus 28

29 植物原料的安全性风险评估 Safety risk assessment to plant in cosmetics 随着植物化学基础研究的不断深入和药理毒理学研究的发展, 也许还会发现更多的具有潜在风险的成分因此, 相对于植物原料在化妆品中的应用日益增多, 植物原料的安全性风险评估将是今后我们面临的重要问题 With further in-depth fundamental phytochemical researches and development in pharmacology and toxicology, more components with potential risk may be discovered. Therefore, safety risk assessment will be the major concern to us in the future, considering the increasing application of natural plants in cosmetics. 29

30 植物新原料申报的化学要求 Declaration Requirements of New Plant Materials 研发报告 Research and Development Report 原料研发的背景过程及相关的技术资料 Background, procedures and relevant technical information of raw materials R&D 原料的名称 (INCI 名称和标准中文名称 ) 来源 ( 天然原料应为单一来源, 并提供使用部位等原料不应是复配而成, 在原料中由于技术原因不可避免存在的溶剂稳定剂载体等除外 ) Raw material s name (INCI name and standard Chinese name), source (natural raw materials should be single source and provide application position info etc.; raw materials should not be in compound form except for the existence of solvent, stabilizer, except the carrier etc. that are technically unavoidable.) 30

31 植物新原料申报的化学要求 Declaration Requirements of New Plant Materials 原料理化性质 ( 颜色气味状态溶解度等 ) Physical and chemical properties of raw materials (colour, odor, state, solubility etc.) 原料的在化妆品中的使用目的使用范围基于安全的使用限量和依据注意事项警示语等 Application purpose, range and limits based on safety as well as precautions and warnings etc of raw materials in cosmetics. 原料在国外 ( 地区 ) 是否使用于化妆品的情况说明等 Statement of whether raw materials used in cosmetics that originate from foreign countries are suitable for use in cosmetics. 31

32 植物新原料申报的化学要求 Declaration Requirements of New Plant Materials 生产工艺简述及简图 Brief Introduction and Illustration of Production Process 应说明加工提取方法提取条件使用溶剂可能残留的杂质或溶剂等 Should identify the method of processing, extraction, extraction condition, solvent, possible remained impurity or solvent etc. 32

33 植物新原料申报的化学要求 Declaration Requirements of New Plant Materials 原料质量安全控制要求 Requirements of Raw Material Safety Certification Control 应包括规格检测方法可能存在的安全性风险物质及其控制措施等内容 Should include standard, inspection method, components with possible safety risks and related control methods etc. 天然植物提取物, 应明确其质量安全控制指标 For natural plant extracts, should identify the control index of safety qualification explicitly. 33

34 植物新原料申报的化学要求 Declaration Requirements of New Plant Materials 原料的定性和定量检测方法杂质的检测方法等 Qualitative and quantitative testing methods of raw materials and testing methods of impurities etc. 可能存在的安全性风险物质及其控制措施 Components with potential safety risk and their control methods. 34

35 植物新原料的安全性风险评估 Safety Risk Assessment of New Plant Materials 化妆品中可能存在的安全性风险物质的含义 The definition of components with potential safety risks in cosmetics 化妆品中可能存在的安全性风险物质是指由化妆品原料带入生产过程中产生或带入的, 可能对人体健康造成潜在危害的物质 It refers to those components that may cause potential risk to human health, resulted from raw materials and brought or produced during the production process 如 : 呋喃香豆素类, 石榴皮碱, e.g.: furocoumarin, pelletierine 35

36 植物原料的安全性风险评估 Safety Risk Assessment of New Plant Materials 化妆品中可能存在的安全性风险物质评估资料的审评应当符合化妆品中可能存在的安全性风险物质评估指南的要求 The evaluation of assessment material for potential ti risky components in cosmetics should meet the requirement of the Guidance of Potential Risky Component Assessment for Cosmetics. 毒理学试验前, 须对待评估的原料进行确认 Before the toxicological test, identification of the raw material for assessment is required. 毒理学安全性评价按照化妆品新原料申报与审评指南要求执行 The safety assessment of toxicology test should follow the Application and Inspection of Cosmetics New Raw Material Guidance Legislation. 36

37 总结 Summary 化妆品定义及其一般要求 Definition and General Requirements of Cosmetics 植物原料在化妆品中的应用现状 Current Situation of Plant Application in Cosmetics 植物原料的安全性分析 Safety Analysis of Plants in Cosmetics 植物新原料申报的化学要求 Declaration Requirements of New Plant Materials 植物新原料的安全性风险评估 Safety Risk Assessment of New Plant Materials 37

38 Thanks! Yue Shi Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing , PR China 38

4期

中国农学通报 2013,29(04):39-43 Chinese Agricultural Science Bulletin 中药荆芥最新研究进展 1,2 1,2 赵立子, 魏建和 ( 1 北京协和医学院药用植物研究所, 北京 100193; 2 中草药物质基础与资源利用教育部重点实验室, 北京