CN112869160B - 一种含叶酸的祛斑组合物及其制备方法 - Google Patents
一种含叶酸的祛斑组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及具有祛斑功效产品技术领域，具体涉及一种含叶酸的祛斑组合物及其制备方法。本发明祛斑组合物原料包括白芷，绿豆，葡萄皮提取物，甘草和叶酸类化合物，其制备方法包括先将白芷、绿豆、甘草粉碎过筛，然后将部分白芷粉和甘草粉混合水提再醇提得干膏粉1和挥发油1，最后将其和其他原料混合干燥灭菌即得。本发明组合物原料组成数量简单，制备工艺稳定，制得的组合物具有明显的祛斑效果。
Description
技术领域
本发明涉及具有祛斑功效的保健品技术领域，具体涉及一种祛斑组合物及其制备方法。
背景技术
随着社会的发展和人们生活水平的不断提高，人们对自己的外表越来越重视，色斑成了生活中长时间困扰人们的问题。黄褐斑俗称“蝴蝶斑”，“肝斑”或者“妊娠斑”。主要发生在面部，以颧部、颊部、鼻、前额、颏部为主。为边界不清楚的褐色或黑色的斑片，多为对称性。
黄褐斑的出现多数与内分泌有关，尤其是和女性的雌激素水平有关，月经不调、妊娠、服避孕药或肝功能不好以及慢性肾病都可能出现黄褐斑。此外日晒和精神因素也会加重本病。孕妇常常在妊娠3个月以后出现黄褐斑，多数人在分娩后月经恢复正常时逐渐消退。如果长期不退，需要进行治疗。
传统的美白化妆品中曾采用过氧化氢、氯化氨基汞等类白剂,这些成分通过瓦解黑色素组织来达到美白效果,可迅速显效,但对皮肤具有腐蚀性、刺激性、致敏性,甚至毒性,因此已被禁用于普通化妆品。对苯二酚是使用历史悠久的美白功效成分,其通过多种途径抑制黑色素的生成。但其细胞毒性和副作用很大，可引起永久性的皮下黑色素减退。
现代女性越来越注重皮肤的保养，即使在怀孕期间也希望拥有美丽容颜，怀孕女性普遍存在“内虚”、免疫力差、皮肤敏感、便秘等症状，影响体内毒素排出，更容易形成妊娠斑、黄褐斑等，导致孕妇肤色暗沉。但是，产妇体质敏感，而植物添加剂绿色、安全，适用面广,无副作用或副作用小，因此如何选择合适的植物添加剂应用于孕妇，且祛斑效果良好成为一个重要的研究课题。
中国发明专利申请CN111297788A公开了一种美白淡斑精华，包括以下组分原料：组分A1：去离子水、覆盆子酮葡萄糖拭、甘油、白藜芦醇、川芎提取物、当归提取物、甘草提取物、芍药提取物、润肤剂；组分A2：烟酰胺保湿剂；组分B：凝血酸、熊果苷、丙二醇、光果甘草根提取物、鞣花酸、厚朴树皮提取物、当归根提取物、乳化剂；组分C：防腐剂；组分D1：红没药醇、叶酸；组分D2：珍珠提取物、乳化剂、增稠剂；组分D3：乙基己基甘油和增稠剂；组分D4：去离子水、人参根提取物、苯氧乙醇、乙基己基甘油、甘草酸二钾、羟乙基纤维素、生育酚、辛甘醇、氢化卵磷脂、透明质酸钠；该发明的美白淡斑精华富含美白祛斑成分,淡化斑点。
中国发明专利CN103431318B公开了一种女性色斑患者食用的特殊膳食，包括以下重量份数的原料：野葛根1000g、青木瓜1000g、阿胶1000g、枸杞1000g、玫瑰花1000g、玳玳花1000g、白扁豆花1000g、玫瑰花1000g、维生素C1000g、无花果1000g、玉竹1000g、荞麦花粉1900g、大麦苗1000g、白芷900g、佛手900g、桃仁900g、海洋鱼低聚肽粉900g、乳酸亚铁900g、叶酸900g、胶原蛋白900g、双歧杆菌900g、嗜酸乳杆菌900g、低聚果糖900g、干酪乳杆菌900g、嗜热链球菌900g、蚕蛹900g、共轭亚油酸900g、水苏糖900g、平卧菊三七900g、向日葵花粉900g、紫云英花粉900g、玉米花粉800g、盐藻提取物800g、抗性糊精800g、牛奶碱性蛋白800g、鱼油提取物800g、泛酸800g、牛磺酸800g、库拉索芦荟凝胶800g、人参800g、玫瑰茄800g、磷酸氢钙800g、磷脂酰丝氨酸800g、低聚木糖800g、大豆低聚糖800g、纳豆800g、松子仁800g、山药800g、百合700g、酸枣仁700g、莲子芯700g、蛋白粉700g、乌梅700g、桑椹700g、黑芝麻700g、意苡仁700g、杏仁700g、桂枝600g、海带600g、莲子600g、荔枝600g、炮姜600g、山楂600g、肉桂600g、陈皮600g、薄荷600g、淮小麦600g、木糖醇600g、茴香500g、黄豆500g、黑豆500g、绿豆500g、沙棘500g、栀子500g、茯苓500g、香菇500g、菊花500g、扁豆500g。相比前一个专利申请，原料更加复杂，成本高，效果不得而知，且其中不乏有很多不适于孕妇食用的中药，例如山楂、薏苡仁等。
以上两种原料纷繁复杂，在给肌肤带来祛斑效果的同时，也给肌肤带来了不必要的负担。因此急需研发一种适合于产妇食用的处方简单、原料来源广泛、祛斑效果好的组合物，其组合物的开发必将具有广阔的市场前景和社会效益。
发明内容
针对现有技术存在的不足，本发明欲解决的问题是现有技术中没有专门针对适合孕妇用的、处方简单、无毒副作用的祛斑产品的技术问题。本发明提供一种适合孕妇用的祛斑组合物，配方各味药相辅相成，具有明显的祛斑、紧致肌肤的效果，并且安全可靠，食用方式方便快捷。
本发明的一个目的在于提供一种适合孕妇用的祛斑组合物，包括如下原料：白芷，绿豆，葡萄皮提取物，甘草和叶酸类化合物。
优选地，上述组合物包括如下重量份数的原料：白芷20-50份，绿豆20-50份，葡萄皮提取物10-30份，甘草10-30份和叶酸类化合物0.01-0.05份。
优选地，上述组合物包括如下重量份数的原料：白芷30-40份，绿豆30-40份，葡萄皮提取物10-20份，甘草10-20份和叶酸类化合物0.01-0.02份。
优选地，上述组合物包括如下重量份数的原料：白芷35份，绿豆35份，葡萄皮提取物15份，甘草15份和叶酸类化合物0.015份。
优选地，叶酸类化合物为叶酸、甲酰四氢叶酸、L-甲基叶酸、叶酸可药用盐、叶酸或叶酸可药用盐的活性代谢产物和可在体内代谢和/或生成叶酸的物质中的一种或几种。
各组分常用功效：
绿豆：性味，味甘，性寒。作用：能消暑、利水、清热解毒。可用于治疗热毒疮疡肿痛，预防麻疹；善解热毒，为附子、巴豆、等辛热毒烈之剂中毒及食物中毒等的解毒良药；可清热消暑，夏日煮绿豆汤可预防中暑；可治疗小便不通，淋漓不畅。
白芷：性温，味辛，气芳香，微苦。功能主治祛风散寒，通窍止痛，活血排脓，生肌止痛，燥湿止带。
甘草：根和根系主含三萜皂苷，其中主要的一种俗称甘草甜素，又含黄酮素类化合物甘草苷元、甘草甙等，还含香豆精类化合物甘草香豆精、甘草酚等，另含生物碱、甘草葡聚糖GBW等化合物。味甘、性平，归脾、胃、心、肺经，益气补中，缓急止痛，润肺止咳，泻火解毒，调和诸药。现代药理研究：主要活性成分是三萜皂苷和黄酮类化合物。甘草总黄酮与中枢5-HT神经功能有关，具有抗应激抑郁以及平衡体内激素的作用。本发明对甘草的炮制方法为：取甘草，除去芦头及杂质，大小条分开，浸泡至三四成透时，捞起润软，切厚片，干燥。
葡萄皮中含有丰富的多酚类物质，主要有低聚原花青素和花色素苷、白藜芦醇，其原花青素聚合度远高于葡萄籽原花青素，葡萄皮提取物具有较强的抗氧化能力。
叶酸：也叫维生素B9，叶酸是指四氢叶酸及其衍生物这一类物质，属于水溶性B族维生素。它由碟啶核、对氨苯甲酸、谷氨酸三部分组成，人体不能合成，必须从动物植物性食物中摄取。作为主要一碳单位供体，叶酸参与核酸、氨基酸、蛋白质的生物合成，并且能够促进细胞分裂、生长。
本发明的另一目的是提供一种上述祛斑组合物的制备方法，包括如下步骤：
(1)将白芷、绿豆粉碎过筛，得白芷粉、绿豆粉备用；将甘草炮制，粉碎，过10-24目筛得甘草粉备用；
(2)将部分白芷粉和甘草粉混合，加水浸泡水蒸气蒸馏提取，期间收集挥发油1，提取时间2-4h，过滤得滤液1，滤渣加6-8倍量50-65％乙醇溶液回流提取，温度60-80℃，提取时间1-2h，过滤得滤液2；合并滤液1和滤液2，浓缩，干燥，粉碎，得干膏粉1；优选地所述提取方法为将甘草粉和部分白芷粉混合加入8-10倍量的水进行提取，提取温度95-100℃；
(3)将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、叶酸类化合物、干膏粉1混合，即得；
优选地，将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、叶酸类化合物、干膏粉1混合，制成祛斑组合物。
优选地，上述步骤(1)中白芷粉碎过10-24目筛；
优选地，绿豆粉碎过65-80目筛；
优选地，甘草炮制具体操作为：取甘草，除去芦头及杂质，浸泡至含水分30-50％时，捞起润软，切厚片，干燥。
优选地，步骤(2)中所述部分白芷粉为40-60％总质量的白芷粉；
优选地，步骤(2)中所述浸泡温度为65-80℃，浸泡时间为1-3h；
优选地，步骤(2)中所述浓缩为减压浓缩，浓缩至60℃下相对密度1.1-1.2的浓缩液；所述干燥为减压干燥，干燥至干膏粉中水分含量≤10％；所述粉碎为粉碎过65-85目筛；
优选地，步骤(3)中混合时间为60-80min；
优选地，步骤(3)混合后还包括在75～85℃下干燥消毒1～3小时，经粉碎，过筛，得祛斑有效成分组合物。
本发明的再一目的是提供一种组合物，包括上述祛斑组合物或上述制备方法制备的祛斑组合物。
本发明的另一目的是提供上述祛斑组合物或上述制备方法制备的祛斑组合物在制备具有祛斑功效的食品、保健品或药品中的应用。
本发明的有益效果：
(1)本发明祛斑保健品组合物具有明显的祛斑、紧致肌肤的效果，并且无毒副作用、安全可靠，食用方式方便快捷，适用于孕妇服用。
(2)本发明的组合物中含有叶酸，在与绿豆、白芷粉和葡萄皮提取物协同祛斑的同时，还能够提高产妇的新陈代谢，补充叶酸，改善产妇的体质。
(3)本发明创造性地将绿豆、白芷粉和葡萄皮提取物进行有效的配伍，获得了良好的抗氧化、祛斑、紧致肌肤的效果，并通过联合使用绿豆、白芷粉和甘草，协同发挥有效紧致产后女性松弛的肌肤，淡化妊娠纹的生成的作用。
(4)本发明的组合物针对女性产后这一特殊时期，不能服用药物的特性，采用中医的理念，基于中医基础理论合理组方不仅能祛斑、紧致肌肤，还能够明显改善产妇便秘情况。
具体实施方式
下面结合实施例对本发明技术方案作进一步说明。
实施例1
本实施例祛斑组合物的原料及组成为：白芷35份，绿豆35份，葡萄皮提取物15份，甘草15份和叶酸类化合物0.01份，其中叶酸类化合物为叶酸。其中葡萄皮提取物购自西安旭全生物技术有限公司，货号XQ-8563，含有白藜芦醇98％。
该祛斑保健品组合物的制备方法如下：
(1)将白芷粉碎过10目筛，得白芷粉备用；将绿豆粉碎过65目筛，得绿豆粉备用；将甘草除去芦头及杂质，浸泡至含水分30％时，捞起润软，切厚片，干燥，粉碎，过10目筛得甘草粉备用；
(2)将(1)中50％白芷粉和甘草粉混合，加水浸泡，浸泡温度为75℃，浸泡时间为1h；然后加入8倍量水进行水蒸气蒸馏法提取，提取温度为100℃，收集挥发油1，提取时间3h，过滤，得滤液1；滤渣加6倍量65％乙醇溶液提取，提取温度60℃，提取时间2h，过滤，得滤液2；合并两次滤液，减压浓缩至60℃下相对密度1.10的浓缩液，再将浓缩液减压干燥至干膏粉中水分含量5.5％，粉碎，得干膏粉1；
(3)将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、叶酸、干膏粉1在混合机中混合80分钟，在85℃下干燥消毒2.5小时，粉碎，过65目筛，得祛斑组合物。
实施例2
本实施例祛斑组合物的原料及组成为：白芷20份，绿豆50份，葡萄皮提取物10份，甘草30份和叶酸类化合物0.05份，其中叶酸类化合物为甲酰四氢叶酸钙，葡萄皮提取物购自西安四叶草生物科技有限公司，含白藜芦醇98％。
该祛斑保健品组合物的制备方法如下：
(1)将白芷过24目筛，得白芷粉备用；将绿豆过80目筛，得绿豆粉备用；将甘草除去芦头及杂质，浸泡至含水分50％时，捞起润软，切厚片，干燥，粉碎，过10目筛得甘草粉备用；
(2)将(1)中40％白芷粉和甘草粉混合，浸泡，浸泡温度为65℃，浸泡时间为2h；然后加入10倍量水进行水蒸气蒸馏提取，提取温度为95℃，期间收集挥发油1，提取时间2h，过滤，得滤液1；滤渣加8倍量50％乙醇溶液回流提取，提取温度80℃，提取时间1h，过滤，得滤液2；合并两次滤液，减压浓缩至60℃下相对密度1.1的浓缩液，再将浓缩液减压干燥至干膏粉中水分含量5.2％，粉碎，得干膏粉1；
(3)将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、甲酰四氢叶酸钙、干膏粉1在混合机中混合60分钟，在75℃下干燥消毒1小时，粉碎，过65目筛，得祛斑组合物。
实施例3
本实施例祛斑组合物的原料及组成为：白芷50份，绿豆20份，葡萄皮提取物30份，甘草10份和叶酸类化合物0.01份，其中叶酸类化合物为亚叶酸钙。其中葡萄皮提取物购自西安绿腾生物科技有限公司，货号LT2017050504，含有白藜芦醇98％。
该祛斑保健品组合物的制备方法如下：
(1)将白芷过10目筛，得白芷粉备用；将绿豆过65目筛，得绿豆粉备用；将甘草除去芦头及杂质，浸泡至含水分30％时，捞起润软，切厚片，干燥，粉碎，过24目筛得甘草粉备用；
(2)将(1)中60％白芷粉和甘草粉混合，浸泡，浸泡温度为80℃，浸泡时间为2h；然后加入8倍量水进行水蒸气蒸馏提取，提取温度为100℃，期间收集挥发油1，提取时间4h，过滤，得滤液1；滤渣加6倍量65％乙醇溶液提取，提取温度70℃，提取时间2h，过滤，得滤液2；合并两次滤液，减压浓缩至60℃下相对密度1.2的浓缩液，再将浓缩液减压干燥至干膏粉中水分含量6.0％，粉碎，得干膏粉1；
(3)将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、叶酸类化合物、干膏粉1在混合机中混合80分钟，在85℃下干燥消毒3小时，粉碎，过65目筛，得祛斑组合物。
实施例1-1
本实施例与实施例1的区别是，将葡萄皮提取物15份去掉，白芷调整为42.5份，绿豆调整为42.5份，其余与实施例1保持一致。
实施例1-2
本实施例与实施例1的区别是，将白芷35份去掉，葡萄皮提取物调整为32.5份，绿豆调整为52.5份，其余与实施例1保持一致。
实施例1-3
本实施例与实施例1的区别是，将绿豆35份去掉，将白芷调整为52.5份，葡萄皮提取物调整为32.5份，其余与实施例1保持一致。
实施例1-4
本实施例与实施例1的区别是，祛斑组合物的原料及组成为：白芷35份，绿豆55份，葡萄皮提取物15份和甘草5份，其余与实施例1保持一致。
实施例1-5
本实施例与实施例1的区别是，将制备方法步骤中白芷粉与甘草粉单独提取，制备方法步骤，具体步骤如下：
(1)将白芷过10目筛，得白芷粉备用；将绿豆过65目筛，得绿豆粉备用；将甘草除去芦头及杂质，浸泡至含水分30％时，捞起润软，切厚片，干燥，粉碎，过10目筛得甘草粉备用；
(2)将50％白芷粉浸泡，浸泡温度为75℃，浸泡时间为1h；然后加入8倍量水进行水蒸气蒸馏法提取，提取温度为100℃，期间收集挥发油1，提取时间3h，过滤，得滤液1；滤渣加6倍量65％乙醇溶液提取，提取温度60℃，提取时间2h，过滤，得滤液2；合并两次滤液，减压浓缩至60℃下相对密度1.10的浓缩液，再将浓缩液减压干燥至干膏粉中水分含量5.0％，粉碎，得干膏粉1；
(3)将甘草粉浸泡，浸泡温度为75℃，浸泡时间为1h；然后加入8倍量水进行水蒸气蒸馏法提取，提取温度为100℃，期间收集挥发油2，提取时间3h，过滤，得滤液3；滤渣加6倍量65％乙醇溶液提取，提取温度60℃，提取时间2h，过滤，得滤液4；合并两次滤液，减压浓缩至60℃下相对密度1.10的浓缩液，再将浓缩液减压干燥至干膏粉中水分含量5.0％，粉碎，得干膏粉2；
(4)将绿豆粉、剩余白芷粉、葡萄皮提取物、挥发油1、挥发油2、叶酸、干膏粉1和干膏粉2在混合机中混合80分钟，在85℃下干燥消毒2.5小时，粉碎，过65目筛，得祛斑组合物。
实施例1-6
本实施例与实施例1的区别是，将制备方法步骤中白芷调整为白术，其余与实施例1保持一致。
试验例1
1.1目的：研究本发明药物对黄褐斑大鼠的治疗作用，对相关生化指标进行检测；
1.2方法：腿部注射黄体酮复制黄褐斑大鼠模型，灌胃给药各实施例制备的祛斑组合物颗粒剂5周后，分别测定血清中超氧化物歧化酶、丙二醛的含量及皮肤超氧化物歧化酶、丙二醛、酪氨酸的含量；
1.3实验材料：黄体酮(1ml/20mg)：浙江医药股份有限公司仙琚制药厂；SOD、MDA试剂盒：南京建成生物工程研究所；
1.4实验动物：SD大鼠，体重200±50g，普通级，雌性未孕，共55只；购自北京维通利华试验技术有限公司，许可证编号：生产许可SCXK(沪)2017-0011。于清洁环境中自由进食。
1.5实验步骤：
(1)黄褐斑大鼠模型的复制：将50只雌性大鼠，采用黄体酮肌注7.5mg/kg，注射时间为30d，复制黄褐斑大鼠模型。另取5只大鼠为空白对照组，注射等体积生理盐水。
(2)分组及给药：将上述50只大鼠按随机数字表分为模型组、实施例1组，实施例2组，实施例3组，实施例1-1组，实施例1-2组，实施例1-3组，实施例1-4组，实施例1-5组，实施例1-6组；每组5只，按0.3g/kg剂量每天灌胃给药1次，连续2周，每周检测一次体重。另外注射生理盐水的5只作为正常组。末次给药禁食12h，称重，切取大鼠皮肤1块、肝脏1块，各称取0.5g，加入10ml预先冷藏的生理盐水匀浆，3000r/min离心15min，制备血清，试剂盒检测血清中SOD、MDA含量，采用同步荧光分析法检测酪氨酸的含量，结果见表1。
实验结果及分析：统计学处理：实验数据以均值±标准差
表示，采用SPSS13.0统计软件进行数据处理，组间比较采用方差分析及LSD-t检验，P<0.05为差异有统计学意义。
表1各实施例组对模型大鼠SOD、MDA和酪氨酸的含量的影响
注：不同字母之间表示两组比较p＜0.05，差异具有显著性。
试验例2急性毒性实验
2.1目的：评价本发明祛斑保健品组合物的毒副作用
2.2实验材料：健康成年ICR系小鼠；灌胃针，动物体重秤，注射器，实施例1祛斑保健品组合物；
2.3分组及给药：健康成年雌性小鼠50只，体重20±2g，按照随机数字表分成5组，称取祛斑组合物50g、100g、200g、300g、400g分别溶于100ml纯化水中，制成浓度分别为0.5g/ml、1g/ml、2g/ml、3g/ml、4g/ml的祛斑组合物溶液。5组小鼠分别灌胃不同浓度的祛斑保健品组合物溶液，小鼠灌胃体积为0.5ml/10g。给药4h后观察1次，之后每天早晚各观察1次，连续观察7d。观察目标主要有小鼠被毛的光滑度，小鼠的活动，眼角膜血丝情况，小鼠饮食，体重，并记录小鼠的死亡数，试验中若有小鼠中毒死亡则对其进行剖检，观察各组织器官的变化。
2.4实验结果
试验例3人体试食试验
本发明按照《保健食品检验与评价规范》对面部有黄褐斑及有妊娠纹、便秘的人群进行人体试食试验。
受试者纳入标准为符合下列要求的自愿受试者：
1.面部淡褐色至深褐色斑点，界限清楚的斑片，无炎性表现；
2.病情有一定的季节性，夏重冬轻；
3.除内分泌以外无明显其他疾病引起的色素沉着。
试验样品：实施例1、实施例1-4制备的祛斑组合物，温水冲服；
试验设计及分组：选择自愿参加的脸部有色斑、有妊娠纹、便秘的产妇(均已过哺乳期10个月)志愿者30名，年龄25-38岁。分组时尽可能考虑影响结果的主要因素如户外活动情况、性别、年龄等，进行均衡性检验，以保证组间的可比性。
试验方法：各组志愿者口服祛斑组合物颗粒剂，1g/次，一日三次，连续试用2个月，试用期间不改变原来的饮食习惯。
观察指标：
安全性指标：一般指标：精神、睡眠、饮食、大小便、血压等。
功效指标：
(1)颜面部黄褐斑面积大小检测用标尺测量受试前后整个颜面部黄褐斑的面积(mm2)
(2)颜面部黄褐斑颜色深浅检测按中国科学院地理研究所设计研制,测绘出版社1992年出版的《实用标准色卡》(第一版)中的棕色(Y+M+BK即黄+品红+黑的叠色)色卡为黄褐斑深浅的判断标准:Ⅰ度(15,20,5),Ⅱ度(30,40,10),Ⅲ度(40,60,15)。
数据处理和结果判定
对试食前后黄褐斑颜色积分和面积变化进行统计分析，同时计算有效率。色卡Ⅰ度、Ⅱ度、Ⅲ度分别记1分、2分和3分。
功效判定标准：
祛斑有效:黄褐斑颜色下降Ⅰ度,面积减少大于10％,且不产生新黄褐斑；
祛斑无效:黄褐斑颜色及面积无明显变化。
淡化妊娠纹有效：妊娠纹纹路明显变细，颜色变浅；
淡化妊娠纹无效：妊娠纹纹路和颜色较试吃前无差异；
缓解便秘有效：根据受试者主诉，便秘缓解，每日有便意，排便明显通畅；
缓解便秘无效：根据受试者主诉，便秘情况无缓解。
结果判定：试食组黄褐斑面积平均减少，且大于等于10％，颜色积分明显下降，自身前后比较及与对照组比较，差别均有显著性，且不产生新的黄褐斑，可判定该受试样品具有祛黄褐斑功能作用。
实验结果分析：采用t检验进行分析。自身对照资料采用配对t检验。
(1)安全性评价：试验前后两组产妇志愿者精神、睡眠、饮食、血压等与试吃前无差异，并且意外发现，试吃实施例1组的祛斑组合物，有10位产妇主诉平时时常有便秘现象，在试吃本发明产品15天左右便秘明显缓解，大便正常。
(2)各实验组志愿者黄褐斑面积减少情况
注：与自身对照相比，*P＜0.01，#P＜0.05。
(3)黄褐斑颜色变化比较(积分)
| 分组 | 人数 | 试吃前 | 试吃后 | 差值 |
| 实施例1组 | 15 | 2.4±0.1 | 1.0±0.4<sup>*</sup> | 1.4 |
| 实施例1-4组 | 15 | 2.1±0.3 | 1.6±0.3<sup>#</sup> | 0.5 |
注：与自身对照相比，*P＜0.01，#P＜0.05。
(4)祛黄褐斑、美白、减缓妊娠纹功效
结果分析：本发明将已过哺乳期的产妇随机分组，并考虑影响结果的主要因素如户外活动情况、性别、年龄等，因此各组间具有可比性。由结果可知，本发明的祛斑组合物颗粒剂食用两个月，对产妇具有较明显的祛斑、淡化妊娠纹的作用，且具有明显缓解便秘的功效。
上述详细说明是针对本发明其中之一可行实施例的具体说明，该实施例并非用以限制本发明的专利范围，凡未脱离本发明所为的等效实施或变更，均应包含于本发明技术方案的范围内。
Claims (13)
1.一种含叶酸的祛斑组合物，其特征在于，所述组合物包括如下重量份数的原料：白芷20-50份，绿豆20-50份，葡萄皮提取物10-30份，甘草10-30份和叶酸类化合物0.01-0.05份；
所述的祛斑组合物的制备方法，包括如下步骤：
（1）将白芷、绿豆粉碎过筛，得白芷粉、绿豆粉备用；将甘草炮制，粉碎，过10-24目筛得甘草粉备用；
（2）将部分白芷粉和甘草粉混合，加水浸泡，然后水蒸气蒸馏提取，期间收集挥发油1，提取时间2-4h，过滤得滤液1，滤渣加6-8倍量50-65%乙醇溶液回流提取，温度60-80℃，提取时间1-2h，过滤得滤液2；合并滤液1和滤液2，浓缩，干燥，粉碎，得干膏粉1；
（3）将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、叶酸类化合物、干膏粉1混合，制成祛斑组合物。
2.根据权利要求1所述的祛斑组合物，其特征在于，所述组合物包括如下重量份数的原料：白芷30-40份，绿豆30-40份，葡萄皮提取物10-20份，甘草10-20份和叶酸类化合物0.01-0.02份。
3.根据权利要求1所述的祛斑组合物，其特征在于，所述组合物包括如下重量份数的原料：白芷35份，绿豆35份，葡萄皮提取物15份，甘草15份和叶酸类化合物0.015份。
4.根据权利要求1-3任意一项所述的祛斑组合物，其特征在于，所述的叶酸类化合物为叶酸、甲酰四氢叶酸、L-甲基叶酸、叶酸可药用盐中的一种或几种。
5.一种根据权利要求1-4任意一项所述的祛斑组合物的制备方法，其特征在于，包括如下步骤：
（1）将白芷、绿豆粉碎过筛，得白芷粉、绿豆粉备用；将甘草炮制，粉碎，过10-24目筛得甘草粉备用；
（2）将部分白芷粉和甘草粉混合，加水浸泡，然后水蒸气蒸馏提取，期间收集挥发油1，提取时间2-4h，过滤得滤液1，滤渣加6-8倍量50-65%乙醇溶液回流提取，温度60-80℃，提取时间1-2h，过滤得滤液2；合并滤液1和滤液2，浓缩，干燥，粉碎，得干膏粉1；
（3）将剩余白芷粉、绿豆粉、葡萄皮提取物、挥发油1、叶酸类化合物、干膏粉1混合，制成祛斑组合物。
6.根据权利要求5所述的祛斑组合物的制备方法，其特征在于，步骤（2）中所述提取方法为将甘草粉和部分白芷粉混合加入8-10倍量的水进行提取，提取温度95-100℃。
7.根据权利要求5所述的祛斑组合物的制备方法，其特征在于，步骤（1）中白芷粉碎过10-24目筛；绿豆粉碎过65-80目筛；所述甘草炮制具体操作为：取甘草，除去芦头及杂质，浸泡至含水分30-50%时，捞起润软，切厚片，干燥。
8.根据权利要求5所述的祛斑组合物的制备方法，其特征在于，步骤（2）中所述部分白芷粉为40-60%总质量的白芷粉；所述浸泡温度为65-80℃，浸泡时间为1-3h。
9.根据权利要求5所述的祛斑组合物的制备方法，其特征在于，步骤（2）中所述浓缩为减压浓缩，浓缩至60℃下相对密度1.10-1.20的浓缩液；所述干燥为减压干燥，干燥至干膏粉中水分含量≤10%。
10.根据权利要求5所述的祛斑组合物的制备方法，其特征在于，步骤（3）中混合时间为60-80min。
11.根据权利要求5所述的祛斑组合物的制备方法，其特征在于，步骤（3）中混合后还包括在75～85℃下干燥消毒1～3小时，经粉碎，过筛，得祛斑组合物。
12.一种组合物，包括权利要求5-11任意一项所述制备方法制备的祛斑组合物。
13.一种根据权利要求1-4任意一项所述的祛斑组合物或权利要求5-11任意一项所述制备方法制备的祛斑组合物在制备具有祛斑功效的食品、保健品或药品中的应用。
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