CN112826870A - 一种抗过敏、防治湿疹的组合物及其制备方法和应用 - Google Patents
一种抗过敏、防治湿疹的组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种抗过敏、防治湿疹的组合物，其包括以下重量份的原料：苦参3‑10份、秦皮3‑10份、当归1‑6份、地黄1‑6份、黄连1‑2份、白头翁1‑2份、防风1‑2份。还公开了一种所述组合物的制备方法，其包括以下步骤：(1)按配方比例称取各原料，常规粉碎，加入5‑15倍于原料重量的水，80‑100℃提取2‑3次，每次时间15‑90分钟；(2)将步骤(1)的提取液合并后过滤，得到上清液；(3)将步骤(2)中上清液浓缩，得到浓缩液。还公开了所述组合物在制备抗过敏，防治湿疹，温和呵护皮肤的化妆品上的用途。
Description
技术领域
本发明属于化妆品技术领域，具体涉及化妆品中的组合物及其制备方法和应用。
背景技术
皮肤作为人体的第一道生理防线和最大的器官，时刻参与着机体的功能活动，人们的皮肤暴露在空气中，皮肤屏障容易受损，进而引起皮肤过敏、皮炎、湿疹等。目前市场上用于治疗皮肤问题的药膏，一般含有激素、抗生素和抗组胺药等成分，存在副作用和依赖性。近期研究表明，针对湿疹等皮肤问题，在使用药物治疗的基础上，可以搭配温和、滋润、保湿等配方的护肤产品，有效增强皮肤抵抗能力，起到呵护皮肤的辅助作用。
传统中医药有几千年医疗实践经验，以中药资源丰富、价格低廉、效果明显、不良反应少等优点而日益受到重视和应用。中医药在皮肤方面的运用积累了丰富的经验，为了避免激素或抗生素类的外用药膏的副作用和依赖性，积极寻找具有抗过敏，防治湿疹，温和呵护皮肤，能够长期使用的中药组合物具有一定的经济价值和社会效益。
发明内容
本发明的目的在于提供一种抗过敏、防治湿疹的组合物，旨在有效帮助改善和缓解皮肤过敏、湿疹等皮肤问题，温和呵护皮肤。
为了实现上述发明目的，本发明的技术方案之一为：一种抗过敏、防治湿疹的组合物，其包括以下重量份的原料：苦参3-10份、秦皮3-10份、当归1-6份、地黄1-6份、黄连1-2份、白头翁1-2份、防风1-2份。
优选地，所述的抗过敏、防治湿疹的组合物，其由以下重量份的原料组成：苦参10份、秦皮10份、当归1份、地黄1份、黄连1份、白头翁1份、防风1份；苦参5份、秦皮5份、当归3份、地黄3份、黄连1份、白头翁1份、防风1份；或苦参3份、秦皮3份、当归6份、地黄6份、黄连2份、白头翁2份、防风2份。
在上述组合物中，对各原料的来源、性味、归经、功效及有关的研究描述如下：
苦参：为豆科植物苦参Sophora flavescens Ait.的干燥根。味苦，性寒。归心、肝、胃、大肠、膀胱经。功效清热燥湿，杀虫，利尿。苦参水提物能有效减少湿疹豚鼠皮肤的炎症反应[陈燕，张丽华。苦参水提物治疗湿疹豚鼠皮肤炎症的实验研究。现代医院，2015，15（5）：22-24]。
秦皮：为木犀科植物苦枥白蜡树Fraxinus rhynchophylla Hance、白蜡树Fraxinus chinensis Roxb.、尖叶白蜡树Fraxinus szaboana Lingelsh. 或宿柱白蜡树Fraxinus stylosa Lingelsh.的干燥支皮或干皮。味苦、涩，性寒。归肝、胆、大肠经。功效清热燥湿，收涩止痢。秦皮是临床常用中药，临床上用于治疗肠炎、白带过多、牛皮癣等。秦皮具有丰富的药理活性，如抗菌、抗炎、抗氧化、抗过敏等作用[聂安政，林志健，张冰。秦皮化学成分和药理作用。中草药，2016，47（8）：3332-3340]。
当归：为伞形科植物当归Angelica sinensis (Oliv.) Diels的干燥根。味甘、辛，性温。归肝、心、脾经。功效补血活血，调经止痛，润肠通便。当归有“十方九归”之称，富含维生素和矿物质，含17种氨基酸，其中苏氨酸、亮氨酸为人体不能合成而又必须的氨基酸，是肌肤、毛发的养料，能够使人容光焕发、肌肤娇嫩[葛媛，谢若男。活血化瘀、补气血方剂在现代化妆品中的应用。亚太传统医药，2018，14（3）：103-107]。
地黄：为玄参科植物地黄Rehmannia glutinosa Libosch.的新鲜或干燥块根。味甘、苦，性寒。归心、肝、肾经。功效清热凉血，养阴生津。在血燥证的防治中，发现中医具有润燥功能的中药如地黄等植物或其提取物对具有屏障功能和保湿功能的神经酰胺有着明显的生成促进作用；在皮肤屏障与润燥的研究中，临床上还发现生地溶液对改善血燥证患者皮肤干燥和粗糙的临床表现均有较好的防治作用；体现了“中医润燥”与“西医保湿”有着中西医结合异曲同工之妙。[秦万章。血燥证理论在皮肤科中的应用。中国中西医结合皮肤性病学杂志，2014，13（1）：1-6]。
黄连：为毛茛科植物黄连Coptis chinensis Franch.、三角黄连Coptis deltoidea C.Y.Cheng et Hsiao或云连Coptis teeta Wall.的干燥根茎。味苦，性寒。归心、脾、胃、肝、胆、大肠经。功效清热燥湿，泻火解毒。黄连性苦寒，入心经，尤善泻心火、清湿热，将其研成粉末外敷于局部病变皮肤，可达清热燥湿、解毒敛疮之功效。黄连粉外治可治疗脚湿气、春季皮炎、婴儿湿疹等[杨宁。黄连粉应用初探。医学信息，2014，27（3）下：399-400]。
白头翁：为毛茛科植物白头翁Pulsatilla chinensis (Bge.) Regel的干燥根。味苦，性寒。归胃、大肠经。功效清热解毒，凉血止痢。白头翁发挥清热凉血、解毒利湿功效，治疗痢疾、银屑病、慢性荨麻疹、皮肤病等[罗金丽，徐坤元，王涵。白头翁的临床应用及其用量探究。吉林中医药，2020，40（8）：1087-1089 ]。
防风：为伞形科植物防风Saposhnikovia divaricate (Turcz.) Schischk.的干燥根。味辛、甘，性微温。归膀胱、肝、脾经。功效祛风解表，胜湿止痛，止痉。防风作为我国的传统中药，药用历史悠久，临床疗效确切，是非常有价值的药用资源。防风在镇痛、抗炎、抗菌等方面显示出积极的作用，并在头痛、呼吸系统疾病、皮肤病等临床治疗方面有着显著的疗效[刘双利，姜程曦，赵岩，等。防风化学成分及其药理作用研究进展。中草药，2017，48（10）：2146-2152]。
为了实现上述发明目的，本发明的技术方案之一为：一种化妆品，其包括所述的抗过敏、防治湿疹的组合物。
优选地，所述化妆品还包括化妆品学上可接受的试剂或载体。更优选地，所述的抗过敏、防治湿疹的组合物在所述化妆品中的重量百分比为2-30%。进一步优选地，所述的抗过敏、防治湿疹的组合物在所述化妆品中的重量百分比为10%。
本发明所述的抗过敏、防治湿疹的组合物可以处于便于保存的液体状态或固体状态，可以根据本领域中已知的方法添加到化妆品中，制备相应的膏霜、凝露、乳液、化妆水、面膜、清洁剂或其他已知的化妆品。
化妆品学上可接受的有益试剂或载体，包括但不限于皮肤调理剂、保湿剂、乳化剂、抗氧化剂、表面活性剂、增稠剂、防腐剂、精油等，其中皮肤调理剂包括但不限于烟酰胺、尿囊素等，保湿剂包括但不限于甘油、丁二醇、己二醇、D-泛醇、透明质酸钠、透明质酸等；乳化剂包括但不限于山梨糖醇的酯类、失水山梨糖醇酐的酯类等；抗氧化剂包括但不限于抗坏血酸及其衍生物、生育酚及其衍生物等；表面活性剂包括但不限于椰油酰甘氨酸钠、椰油酰两性基二乙酸二钠、月桂醇磺基琥珀酸酯二钠等；增稠剂包括但不限于黄原胶、卡波姆、聚乙烯吡咯烷酮、羟丙基纤维素、羟丙基甲基纤维素、PVM/MA癸二烯交联聚合物等；防腐剂包括但不限于苯氧乙醇、甲基异噻唑啉酮、双咪唑烷基脲、尼泊金酯类等；精油包括但不限于玫瑰油、薄荷油、薰衣草油、月见草油等；按常规工艺制成任何类型的化妆品，包括但不限于凝露、膏霜、乳液、粉底、化妆水、面膜、清洁剂或其他已知的化妆品。
为了实现上述发明目的，本发明的技术方案之一为：所述的抗过敏、防治湿疹的组合物的制备方法，其包括以下步骤：(1)按配方比例称取各原料，常规粉碎，加入5-15倍于药材重量的水，80-100℃提取2-3次，每次时间15-90分钟；(2)将步骤(1)的提取液合并后过滤，得到上清液，所述过滤是用80-120目筛过滤；(3)将步骤(2)中上清液浓缩，得到浓缩液；优选地，步骤(2)中所述过滤为用120目筛过滤。
优选地，所述步骤(2) 的上清液进一步采用陶瓷膜分离法进行再过滤，得滤过液，和/或；步骤(3)中所述的浓缩为减压法或采用反渗透(RO)膜分离法浓缩。
优选地，所述的抗过敏、防治湿疹的组合物的制备方法，其进一步包括如下步骤(4)：将步骤(3)的浓缩液，喷雾干燥，得到固体粉末。
为了实现上述发明目的，本发明的技术方案之一为：所述的抗过敏、防治湿疹的组合物在制备抗过敏，防治湿疹，温和呵护皮肤的化妆品上的用途。
本发明的有益效果为：
(1)以传统中医理论和现代医学研究相结合，组方设计合理，组合物的原料安全可靠，价廉易得。
(2)具有抗过敏，防治湿疹，温和呵护皮肤等效果，可以作为化妆品原料。
(3)本发明组合物的制备方法以传统工艺和现代先进分离技术相结合，体现了传统配方的特色，极大地保留了原料中的各种活性物质。
具体实施方式
下面结合实施例对本发明作详细说明，但不构成对本发明的任何限制。
实施例1 组合物1的制备
1.称取苦参10 kg、秦皮10 kg、当归1 kg、地黄1 kg、黄连1 kg、白头翁1 kg、防风1kg，用锤片式粉碎机（型号WFJ-15，江阴市康和机械制造有限公司）粉碎过5目筛，备用。
2.将粉碎物料加入多功能动态提取罐（型号TT-500，济宁金百特生物机械有限公司），100±5℃提取二次。第一次15倍原料量的水，时间60分钟；第二次10倍原料量的水，时间30分钟，120目筛过滤，滤液合并，滤液用陶瓷膜（膜孔径0.2µm，透过液流速60L/hr）进行微滤，收集截留液，截留液采用反渗透膜（截留分子量100，透过液流速90L/hr）浓缩，浓缩液Brix值（日本ATAGO糖度计）15.8%，浓缩液采用巴氏灭菌后，灌入无菌袋，备用。用纯水稀释浓缩液，定容配制成浓度100mg/L，即1 L纯水中含有100mg组合物。
实施例2 组合物2的制备
1.称取苦参5 kg、秦皮5 kg、当归3 kg、地黄3 kg、黄连1 kg、白头翁1 kg、防风1kg，用锤片式粉碎机粉碎过5目筛，备用。
2.将粉碎物料加入多功能动态提取罐，90±5℃提取三次。第一次12倍原料量的水，时间45分钟；第二次10倍原料量的水，时间30分钟，第三次8倍原料量的水，时间15分钟，120目筛过滤，滤液用陶瓷膜（膜孔径0.2µm，透过液流速60L/hr）进行微滤，收集截留液，截留液采用反渗透膜（截留分子量100，透过液流速90L/hr）浓缩，浓缩液Brix值11.9%，浓缩液采用巴氏灭菌后，灌入无菌袋，备用。用纯水稀释浓缩液，定容配制成浓度100mg/L，即1 L纯水中含100mg组合物。
实施例3 组合物3的制备
1.称取苦参3kg、秦皮3kg、当归6kg、地黄6kg、黄连2kg、白头翁2kg份、防风2 kg，用锤片式粉碎机粉碎过5目筛，备用。
2.将粉碎物料加入多功能动态提取罐，80±5℃提取三次。第一次10倍原料量的水，时间90分钟；第二次8倍原料量的水，时间60分钟；第三次5倍原料量的水，时间30分钟，80目筛过滤，滤液合并，减压浓缩（-0.06Mpa～-0.08Mpa，70±5℃），浓缩液Brix值15.5%，浓缩液采用巴氏灭菌后，灌入无菌袋，备用。用纯水稀释浓缩液，定容配制成浓度100mg/L，即1L纯水中含有100mg组合物。
实施例4：多效呵护霜的制备
1.将原料1、3、4、10、14、15、16、17和原料5、6、7、8、9、11、12、13、19分别加入加水相，油相热锅内，加热至80-85℃搅拌至完全溶解。
2.将原料1、3、4、10、14、15、16、17和原料5、6、7、8、9、11、12、13、19依次加入乳化锅内，保持温度80℃，均质3分钟并保持搅拌半个小时；降至60℃左右，再加入原料20、21，慢慢搅拌均匀；降至45℃左右，再加入原料2、18，慢慢搅拌均匀，得到多效呵护霜。多效呵护霜配方中的成分见表1。
表1 多效呵护霜配方中的成分
对比例1 组合物a的制备
1.称取苦参3 kg、秦皮3 kg、当归6 kg、地黄6 kg、黄连2 kg，用锤片式粉碎机粉碎过5目筛，备用。
2.将粉碎物料加入多功能动态提取罐，80±5℃提取三次。第一次10倍原料量的水，时间90分钟；第二次8倍原料量的水，时间60分钟；第三次5倍原料量的水，时间30分钟，80目筛过滤，滤液合并，减压浓缩（-0.06Mpa～-0.08Mpa，70±5℃），浓缩液Brix值12.3%，浓缩液采用巴氏灭菌后，灌入无菌袋，备用。用纯水稀释浓缩液，定容配制成浓度100mg/L，即1L纯水中含有100mg组合物。
对比例2 组合物b的制备
1.称取苦参3 kg、秦皮3kg、当归6 kg、地黄6 kg、黄连2 kg、防风2kg，用锤片式粉碎机粉碎过5目筛，备用。
2.将粉碎物料加入多功能动态提取罐，80±5℃提取三次。第一次10倍原料量的水，时间90分钟；第二次8倍原料量的水，时间60分钟；第三次5倍原料量的水，时间30分钟，80目筛过滤，滤液合并，减压浓缩（-0.06Mpa～-0.08Mpa，70±5℃），浓缩液Brix值13.7%，浓缩液采用巴氏灭菌后，灌入无菌袋，备用。用纯水稀释浓缩液，定容配制成浓度100mg/L，即1L纯水中含有100mg组合物。
以上实施例和对比例的配方对比见表2。
表2 各组合物所示的成分及比例
| 成分 | 实施例1 | 实施例2 | 实施例3 | 对比例1 | 对比例2 |
| 苦参 | 10份 | 5份 | 3份 | 3份 | 3份 |
| 秦皮 | 10份 | 5份 | 3份 | 3份 | 3份 |
| 当归 | 1份 | 3份 | 6份 | 6份 | 6份 |
| 地黄 | 1份 | 3份 | 6份 | 6份 | 6份 |
| 黄连 | 1份 | 1份 | 2份 | 2份 | 2份 |
| 白头翁 | 1份 | 1份 | 2份 | — | — |
| 防风 | 1份 | 1份 | 2份 | — | 2份 |
效果实施例1
透明质酸( hyaluronic acid，HA) 是细胞外基质( ECM) 中含量最多、所占比例最大的成分，具有很强的吸水能力和粘附性，可调控细胞因子的分泌，影响细胞的生长、增殖、迁移和分化，因而在维持皮肤水分和弹性、创伤愈合和血管形成等过程中起主要的作用。透明质酸酶是透明质酸的特异性裂解酶，抑制透明质酸酶的活性即可保证透明质酸的含量和正常功能。透明质酸酶体外抑制试验是最典型的抗敏活性评价体外方法，以透明质酸酶抑制率为指标评价物质的抗过敏活性，透明质酸酶抑制率越大则抗过敏活性越强。
透明质酸酶体外抑制试验：取0.1mLCaCl2溶液（0.25mmol/L）和0.5mL透明质酸酶液（1250u/mL）37℃保温培养20min；加入样品液0.5mL，继续37℃保温培养20min；加入0.5mL透明质酸钠液（0.5mg/mL）37℃保温30 min，常温放置5 min；加入0.1 mLNaOH溶液（0.4mol/L）和0.5 mL乙酰丙酮溶液，置于沸水浴中加热 15 min后立即用冰水进行冷却5 min；加入埃尔利希试剂1.0 mL并用3.0 mL无水乙醇进行稀释，放置20 min显色，用分光光度计（UV-1750型，日本岛津公司）测定其吸光度值。
透明质酸酶抑制率按式⑴计算:
⑴透明质酸酶抑制率（%）={(A-B)-(C-D)/A-B}×100%。
式中：A 为对照溶液吸光度（用醋酸缓冲溶液代替样品溶液），B 为对照空白溶液吸光度（用醋酸缓冲溶液代替样品溶液及酶液），C 为试样溶液吸光度值，D 为试样空白溶液吸光度（用醋酸缓冲溶液代替酶液）。 试验时先对A对照组试样进行450-700nm范围的波长扫描，以确定最大吸收波长，然后以去离子水作为参比，在该最大吸收波长处分别进行相关组吸光度测定。
采用SPSS19.0 软件进行统计学处理，计量资料采用均数±标准差表示，样品间差异比较用t检验。试验结果见表3。
表3 透明质酸酶体外抑制试验结果
吸光度（ |
抑制率（%） | P值 | |
| 空白对照组 | 0.904±0.040 | — | |
| 组合物1 | 0.348±0.024 | 61.50±2.64** | 0.0035 |
| 组合物2 | 0.342±0.026 | 62.17±2.86** | 0.0027 |
| 组合物3 | 0.312±0.037 | 65.49±4.09** | 0.0011 |
| 组合物a | 0.548±0.024 | 39.38±2.64 | |
| 组合物b | 0.430±0.038 | 52.43±4.21 |
注：透明质酸酶抑制率与组合物b比较，**P<0.01。
如结果所示，本发明实施例1-3制备的组合物1-3和对比例1和2制备的组合物a和b均可以抑制透明质酸酶活性，且本发明实施例1-3得到的组合物1-3效果极为显著。特别是，本发明组合物1-3与对比例2得到的组合物b（对比例中抑制效果最好的）相比，差异具有极显著性，显示本发明的组合物取得了预料不到的技术效果。
效果实施例2：组合物防治湿疹的临床研究
1.受试者纳入标准：按自愿原则选择慢性湿疹者30例，所有入选者均符合慢性湿疹诊断标准[赵辨主编。临床皮肤病学（第3版）。南京: 江苏科学技术出版社，2001:604-606]。
2.受试者排除标准：妊娠或哺乳期妇女；有严重内科疾病或免疫功能低下者；有研究者认为的其它原因而不符合要求者。
3.研究方法
⑴受试物：使用实施例4多效呵护霜。
⑵使用方法：受试者清洗局部，取多效呵护霜直接涂抹患处，3次/天。疗程3周。
⑶标准效果判定：观察指标包括皮损面积、瘙痒及皮损质地3 个方面。各项观察指标的分值相加为总积分。使用多效呵护霜后，以效果指数作为评定依据。效果指数=（用前总积分-用后总积分）/用前总积分×100%。治愈: 效果指数100%，瘙痒症状消失，全部皮损消退; 显效: 效果指数为＞65%，瘙痒明显改善，大部分皮损消退; 好转: 效果指数为＞25%，部分皮疹消退，瘙痒有所改善; 无效: 效果指数＜25%或加重。有效率=（痊愈例数+显效例数+好转例数）/总病例数×100%。采用SPSS19.0 软件进行统计学处理，计量资料用率来表示。试验结果见表4。
表4多效呵护霜使用效果统计（例，%）
| 例数 | 痊愈 | 显效 | 好转 | 无效 | 有效率（%） | |
| 多效呵护霜 | 30 | 3 | 15 | 10 | 2 | 93.3 |
在本次研究中，慢性湿疹者涂抹实施例4多效呵护霜后，有效率为93.3%，多效呵护霜防治慢性湿疹值得推广应用。
效果实施例3：组合物安全性评价-人体斑贴试验
1.试验依据：《化妆品安全技术规范》（2015年版）
2.试验方法和结果：按受试者入选标准选择受试人员，人数为30例。选用合格斑贴材料，将实施例4多效呵护霜用滤纸浸润后放入斑试器内，对照孔为空白对照（不置任何物质）。将实施例4多效呵护霜均匀加入斑试器的小室内，将加有实施例4多效呵护霜的斑试器用无刺激胶带贴敷于志愿者背部，用手掌轻压使之均匀贴敷于皮肤上，斑试器持续停留在皮肤上24 h。去除斑贴器间隔30min, 待压痕消失后观察皮肤反应。斑贴试验后24 h和48h分别观察一次。人体斑贴试验可知，参加此次试验的30名受试者中28人为0级反应，2人为1级反应（可疑反应，仅有微弱红斑），说明实施例4多效呵护霜未对人体皮肤引起不良反应。
最后需要说明的是：上述实施例仅仅是为清楚的说明本发明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其他不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引申出的显而易见的变化或变动仍处于本发明的保护范围之中。
Claims (8)
1.一种抗过敏、防治湿疹的组合物，其特征在于，其包括以下重量份的原料：苦参3-10份、秦皮3-10份、当归1-6份、地黄1-6份、黄连1-2份、白头翁1-2份、防风1-2份。
2.根据权利要求1所述的用于化妆品的组合物，其特征在于，其由以下重量份的原料组成：苦参10份、秦皮10份、当归1份、地黄1份、黄连1份、白头翁1份、防风1份；苦参5份、秦皮5份、当归3份、地黄3份、黄连1份、白头翁1份、防风1份；或苦参3份、秦皮3份、当归6份、地黄6份、黄连2份、白头翁2份、防风2份。
3.一种化妆品，其特征在于，所述化妆品包括如权利要求1或2所述的抗过敏、防治湿疹的组合物。
4.如权利要求3所述的化妆品，其特征在于，所述化妆品还包括化妆品学上可接受的试剂或载体；优选地，所述的抗过敏、防治湿疹的组合物在所述化妆品中的重量百分比为2-30%；更优选地，所述的抗过敏、防治湿疹的组合物在所述化妆品中的重量百分比为10%。
5.一种如权利要求1和2中任一项所述的抗过敏、防治湿疹的组合物的制备方法，其包括以下步骤：(1)按配方比例称取各原料，常规粉碎，加入5-15倍于原料重量的水，80-100℃提取2-3次，每次时间15-90分钟；(2)将步骤(1)的提取液合并后过滤，所述过滤是用80-120目筛过滤；得到上清液；(3)将步骤(2)中上清液浓缩，得到浓缩液；优选地，步骤(2)所述过滤为用120目筛过滤。
6.如权利要求5所述的抗过敏、防治湿疹的组合物的制备方法，其特征在于，所述步骤(2)的上清液进一步采用陶瓷膜分离法进行再过滤，得滤过液，和/或；所述步骤(3)中所述的浓缩为减压法或采用反渗透（RO）膜分离法浓缩。
7.如权利要求5或6所述的抗过敏、防治湿疹的组合物的制备方法，其进一步包括如下步骤(4)：将步骤(3)的浓缩液，喷雾干燥，得到固体粉末。
8.权利要求1和2中任一项所述的抗过敏、防治湿疹的组合物在制备抗过敏，防治湿疹，温和呵护皮肤的化妆品上的用途。
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