CN108904619A - 一种具有皮肤保湿作用的药物组合物 - Google Patents
一种具有皮肤保湿作用的药物组合物 Download PDFInfo
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Abstract
本发明公开了一种具有皮肤保湿作用的药物组合物，其特征在于，所述药物组合物是以如下质量份数的原料制备的：小红参190～210份、倒挂金钩290～310份、天山雪莲140～160份、金莲花140～160份、大花红景天140～160份、纤花耳草140～160份、金佛山雪胆140～160份。本发明还公开了该药物组合物的制备方法。动物实验和人体试验证实本发明的药物组合物皮肤保湿效果显著，具有十分广阔的应用前景。
Description
技术领域
本发明属于医药及日用化学品技术领域，具体涉及一种具有皮肤保湿作用的化妆品用药物组合物及其制备方法。
背景技术
水是保持皮肤健康形态的首要条件，皮肤含水量的多少决定皮肤是否稚嫩、丰满、亮泽与柔软。正常情况下皮肤贮存的水分约占人体所有水量的18％～20％，婴儿皮肤贮水量可高达80％。如果皮肤低于正常水平，就是缺水的皮肤，这样的皮肤往往是颜色暗淡、干燥、蜕皮甚至有细小褶皱的，就个人的主观感受上，过分干燥的皮肤多会伴随干燥、紧绷的感觉。皮肤保湿系统由内而外保湿的作用可以依次归纳为：捕水、锁水、活水和储水。皮肤干燥的人，其脂质屏障从结构到组成都发生紊乱，而屏障的破坏增加了环境压力对皮肤的损伤。干性皮肤中，连接角质层的桥粒不能完成自身的降解程序，致使皮肤代谢功能异常而大量脱屑。同时角质层水合能力降低，通过皮肤的水分损失速度约比正常情况下大10倍，皮肤弹性减弱。一项法国的研究表明，无论其皮肤属于哪一类的女性，90％都有缺水的情况。故而皮肤保湿也成为皮肤护理品和皮肤保健品的最基本功能，也是最主要和最被广泛需求的功能，因此越来越多的人从婴童时期就开始注重皮肤的保湿护理。(赵小敏、翟欣.一种稻米提取物的皮肤保湿和抗老化功能研究[J].中国美容医学，2015，24(4)：35-38)如果皮肤极度缺水，人们就会出现皮肤干燥脱皮，眼角，嘴角和鼻梁上可以看到表情纹，脆弱敏感，常常泛红，缺少弹力等多种症状，这时候就需要外用保湿剂来缓解症状。(Crowther JM，Sieg A，Blenkiron P，et a1.Measuring the effects of topical moisturizers on changes instratum corneum thickness， water gradients and hydration in vivo[J].Br JDermatol，2008，159(3)：567-577)保湿是通过防止皮肤水分散失和吸收外界环境的水分来达到皮肤内保有一定水分的目的，不少营养物质是经水输导至皮肤的，是皮肤保养最重要的环节。因此科学家致力于开发肤感良好、性能优异的皮肤保湿剂作为化妆品原料，如专利201510124906.9，该专利公开了一种皮肤保湿药物组合物及其制备方法。该发明的药物组合物由红葡萄酒2-40份、海藻酸钠1-20份、芦荟1-20份、人参茎叶总皂苷0.01-0.5份、维他命C0.01-0.5份、维他命E0.01-0.5份、小麦胚芽油0.01-0.5份、鱼皮胶原蛋白0.1-2份、玻尿酸0.1-2份、透明质酸0.1-2份重量百分比的药物组成。如专利 201580061120.5，该专利公开了一种包含间歇灭菌的乳酸菌死菌体作为有效成分的用于皮肤保湿或改善皱纹的组合物，具体制备方法：从发酵培养液中分离乳酸菌发酵菌体后，将乳酸菌发酵菌体在60-160℃的温度下加热10至60分钟，并迅速冷却到20-40℃或20℃灭活。
外源性补充合成的皮肤保湿剂方案固然快速，但不能根本、长效改善角质屏障，从而达到长效保湿效果。天然植物来源的皮肤保湿剂性质温和，对皮肤无刺激性，并能够帮助皮肤逐渐恢复正常保湿功能，作用持久，因此备受消费者青睐。中医理论认为津液与美容的关系是很密切的。津液充足，可使皮肤有弹性、饱满湿润，不易老化；若津液不足，皮肤即可干瘪起皱，脱屑瘙痒，易于老化。由于保养不当、工作或生活环境、遗传因素或某些疾病，导致津液大量流失，使面部肌肤失去红润、光泽，无弹性、粗糙晦暗甚至萎黄。不少研究者对中草药的天然皮肤保湿成分进行开发，取得了不少有价值的成果。如专利201080005620.4该专利公开了用于皮肤保湿的组合物，其包含作为有效成分的野鼠尾草籽凝胶。如专利200780051804.2，该专利公开了一种用于缓解皮肤干燥症状的皮肤外用组合物，以及该外用物用作皮肤保湿化妆品的应用，所述外用组合物含有北玄参提取物作为主要成分和茯苓提取物作为活性成分。
发明内容
本发明的要解决的技术问题是克服现有技术中的不足之处，提供一种具有皮肤保湿作用的药物组合物及其用途。
为了解决上述技术问题，本发明首先提供了一种药物组合物。
本发明提供的药物组合物的原料药组成如下：
该药物组合物是以小红参、倒挂金钩、天山雪莲、金莲花、大花红景天、纤花耳草和金佛山雪胆为原料药制备的，且任一组分的重量百分含量均不超过总量的30％；
具有皮肤保湿作用的药物组合物，是以如下质量份数的原料制备的：小红参190～210份、倒挂金钩290～310份、天山雪莲140～160份、金莲花140～160份、大花红景天140～160 份、纤花耳草140～160份、金佛山雪胆140～160份。
优选的，所述具有皮肤保湿作用的药物组合物，是以如下重量份数的原料制备的：小红参200份、倒挂金钩300份、天山雪莲150份、金莲花150份、大花红景天150份、纤花耳草150份、金佛山雪胆150份。
为了解决上述技术问题，本发明还提供了制备上述药物组合物的方法。
本发明提供的制备上述药物组合物的方法包括以下步骤：
(1)将小红参190～210份、倒挂金钩290～310份、天山雪莲140～160份、金莲花140～ 160份、大花红景天140～160份、纤花耳草140～160份、金佛山雪胆140～160份混合均匀，用水作为溶剂提取，得到该药物组合物提取液；
(2)将所述药物组合物提取液浓缩，得到浓缩液，将所述药物组合物浓缩液上大孔树脂柱，用0.6～1.5倍柱体积的水进行洗脱，得到第一洗脱液；
(3)将所述第一洗脱液上强酸型阳离子交换树脂柱，用水洗脱至水洗脱液无糖反应，再用2～8wt％氨水溶液洗脱5倍柱体积至颜色明显变浅，收集所述氨水溶液的洗脱液作为第二洗脱液；
(4)将所述第二洗脱液浓缩，干燥，得到所述药物组合物提取物。
所述药物组合物还包含制剂学上可接受的载体和/或赋形剂，用于制备皮肤保湿的化妆品，如面膜、爽肤水、面霜、乳液、凝胶。
制备皮肤保湿的化妆品时，可将制得的药物组合物提取物，与制剂学上可接受的载体和/ 或赋形剂相混合，按照常规的方法进行制备，其中，所述药物组合物提取物占化妆品总重量的1％～2％。
本发明开展大量筛选实验，从大量的天然药物中，选用了小红参、倒挂金钩、天山雪莲、金莲花、大花红景天、纤花耳草和金佛山雪胆为原料，制备获得了所述的具有皮肤保湿作用的组合物，其中，所述的小红参选用茜草科茜草属植物云南茜草Rubia yunnanensis(Franch) Diels的干燥根，倒挂金钩选用茜草科钩藤属植物倒挂金钩Uncaria lancifoliaHutchins的干燥茎枝；天山雪莲选用菊科风毛菊属植物天山雪莲Saussurea involucrate(Kar.et Kir.)Sch.Bip.的干燥地上部分；金莲花选用毛茛科金莲花属的植物金莲花Trollius chinensis Bunge的干燥花；大花红景天选用景天科红景天属多年生草本植物大花红景天Rhodiola crenulata(Hook.f. Thomson)H.Ohba的干燥根；纤花耳草选用纤花耳草科植物纤花耳草Saxiifragga stolonifera Curt. 的全草；金佛山雪胆选用Hemsleyapengxiamensis W.J Chang varjinfushansis L.T.Shen et W.J. Chang的干燥块根。所有原料药经广东省中医院覃军主任中药师鉴定基源，同时质量符合使用标准，样品凭证保存于广州青岚生物科技有限公司样品室。
根据《中国药典》和文献记载：
小红参是云南特产药材，其为茜草科茜草属植物云南茜草Rubia yunnanensis(Franch) Diels的根，又名滇紫参，小活血，小红药。《云南中草药》记载其能“温经通络，调养气血”。小红参具有温经通络、活血祛风、软坚破积和养血补血之功效，小红参临床应用广泛，毒副作用小，用于治疗风寒湿痹、皮下结节、跌打损伤和血痰等多种疾病。现代研究证实小红参对银屑病有显著的治疗作用，并有抗癌功效。
倒挂金钩为茜草科钩藤属植物倒挂金钩Uncaria lancifolia Hutchins的干燥茎枝，倒挂金钩在云南部分地区作为中药钩藤使用，当地认为其具有清热、平肝和镇惊作用，用于治疗高血压、头晕、目眩、乳腺炎等疾病。
天山雪莲为菊科风毛菊属植物天山雪莲Saussurea involucrate(Kar.et Kir.)Sch.Bip.的干燥地上部分，主要生长在我国新疆天山、阿尔泰山雪线附近的岩缝中，天山雪莲具有补肾活血、强筋骨、营养神经、调节异常体液之功效，用于治疗风湿性关节炎、关节疼痛、肺寒咳嗽、白带过多等疾病。现代研究表明天山雪莲具有良好的抗炎、抗风湿、镇痛、强心、抗氧化等作用，其中含有黄酮类、内酯类、生物碱等多种成分，其中黄酮类是主要药效成分。
金莲花为毛茛科金莲花属的植物金莲花Trollius chinensis Bunge的干燥花，味辛性凉无毒。功能清热解毒。治目赤肿痛，恶毒大疮。据现代医学研究：其种子含葡萄糖金莲橙，果皮含绿原酸和少量黄酮类。根茎、叶柄，特别是叶中含异槲皮甙。花含多种类胡萝卜素、山奈酚葡萄糖甙等成分。
大花红景天是景天科红景天属多年生草本植物大花红景天Rhodiola crenulata(Hook.f. Thomson)H.Ohba，红景天具有抗缺氧、抗疲劳、抗辐射、抗病毒、抗肿瘤、改善心血管系统等多种功能，被誉为“高原人参”。大花红景天的主要药用成分是红景天苷和酪醇。
纤花耳草为茜草科耳草属植物纤花耳草Hedyotis tenelliflora Blume的全草，又名虾子草、鸡口舌，味辛性凉无毒，功能清热解毒，消肿止痛。在民间主要用于治疗肿瘤、毒蛇咬伤、肾炎、肝炎等疾病。
金佛山雪胆为雪胆属肉花雪胆组彭县雪胆的一个变种金佛山雪胆Hemsleyapengxiamensis W.J Chang var jinfushansis L.T.Shen et W.J.Chang的干燥块根，其中富含葫芦烷型四环三萜及其皂苷。金佛山雪胆功能抗菌消炎、清热解毒。现代药理学研究表明该药具有抗菌消炎、抗 HIV、抗肿瘤、保肝等活性。
目前，国内外尚未见将小红参、倒挂金钩、天山雪莲、金莲花、大花红景天、纤花耳草和金佛山雪胆提取物的组合物用于具有皮肤保湿作用的相关报道。
综上所述，本发明人阅读了大量文献，依据皮肤屏障和保湿剂的基本原理，利用动物模型进行高通量筛选，终于发现具有显著皮肤保湿作用的药物组合物。本发明的药物组合物经动物实验和人体临床试验证实效果显著，是一种新型的外用皮肤保湿药物。
具体实施方式
下面结合具体实施方式对本发明进行进一步的详细描述，给出的实施例仅为了阐明本发明，而不是为了限制本发明的范围。
实施例1
在室温下，取小红参2.0公斤、倒挂金钩3.0公斤、天山雪莲1.5公斤、金莲花1.5公斤、大花红景天1.5公斤、纤花耳草1.5公斤、金佛山雪胆1.5公斤，将上述药物混合均匀。加水煎煮3次，第一次加水量为药物重量的8倍量，提取时间为3小时，第二、三次加水量均为药物重量的6倍量，提取时间均为2小时，得到该药物组合物提取液；将该药物提取液减压浓缩至相对密度1.10～1.20(50℃)，冷却至室温得到药物组合物浓缩液；将药物组合物浓缩液过滤，滤液上HPD600型大孔树脂柱，收集未吸附的渗漉液，然后用1倍柱体积的水洗脱，得到得到第一洗脱液；将第一洗脱液与上述未吸附的渗漉液上732强酸型阳离子交换树脂柱，用水洗脱至水洗脱液无糖反应，再用5wt％氨水溶液洗脱5倍柱体积至颜色明显变浅，收集所述氨水溶液的洗脱液作为第二洗脱液；将第二洗脱液浓缩，干燥，得到药物组合物提取物，得率0.6wt％。
实施例2
将实施例1所获得的药物组合物提取物，按照常规乳液制备方法，制备得具有皮肤保湿作用的乳液，组分的重量百分比如下：
生产工艺：搅拌下将A和B相分别加热至70℃，至全部溶解混合均匀，然后在70℃条件下将B相加入A相中，至形成W/Q型乳剂。搅拌均匀后，冷却至室温即得。
本发明较佳实施例所用的基质成分如上所述，本实施例所用的基质成分可以将本发明的药物组合物的功效发挥到最佳。但其它厂家生产的可应用于化妆品的常用基质也可用于本发明，用量只要符合国家化妆品添加剂用量标准即可，不会影响本发明效果，因此不一一列举。
本发明所用的均质乳化设备为上海弗鲁克流体机械制造有限公司生产的FV-30LFISCO 真空均质乳化机，其有均质、搅拌和温控等功能。其它厂家生产的用于化妆品制备的均质乳化设备也可以用于本发明，只要严格按照本发明所述的工艺参数进行操作，均可达到本发明所述的效果。
实施例3
本研究通过颈背部皮下注射D-半乳糖，制造干燥、衰老的小鼠皮肤模型，观察本发明的药物组合物提取物对皮肤的保湿护肤效果和机制，实验中所用的的乳液为实施例2制备的含有1％本发明药物组合物提取物乳液。
1材料与方法
1.1实验动物SPF级雌性ICR小鼠购于北京唯通利华动物有限公司，在广州中医药大学科技产业园药理中心动物房饲养并实验。
1.2实验材料及仪器7500型荧光定量Real-time PCR(美国ABI公司)；Qiagen RNA提取试剂盒(上海贝基生物科技有限公司)；含有1％本发明药物组合物提取物乳液(自制)；10％尿素霜(广州中医药大学科技产业园现代中成药工程中心制备)；D-半乳糖(吉至试剂)；生理盐水(南京正大天晴制药)；中性蛋白酶(Gibco 17105-041)；胰酶(Gibco 25300-054)。
1.3实验分组实验小鼠共40只，分为A、B、C、D4组，每组10只。A组：皮下注射生理盐水，皮肤不涂抹任何产品；B组：皮下注射D-半乳糖，皮肤不涂抹任何产品；C组：皮下注射D-半乳糖，皮肤涂抹10％尿素霜(广州中医药大学科技产业园现代中成药工程中心制备)；D组：皮下注射D-半乳糖，皮肤涂抹含有1％本发明药物组合物提取物乳液(广州青岚生物科技有限公司制备)。
1.4实验方法各组小鼠饲养一周后，开始进行实验。所有小鼠均用6％硫化钠脱毛，露出背部 3×3cm2大小的皮肤。皮下注射剂量为1000mg·kg-1·d-1。各组小鼠按照实验分组进行处理， 6周后，实验结束。禁食一天后，清洁皮肤，脱颈椎处死小鼠。
1.5实验结束后，观察各组小鼠裸露皮肤的色泽、光滑程度、皱纹等外观形态特征。
1.6小鼠皮肤水分含量测定采用中恒温干燥法测定水分含量。
1.7小鼠皮肤角质形成细胞AQP3mRNA测定采用中性蛋白酶分离小鼠皮肤表皮，再通过胰酶分离成单个角质形成细胞。用Trizol抽提角质形成细胞中的RNA，并逆转录成cDNA后通过实时定量PCR SYBRGREEN法(QIAGEN 204143)。PCR的引物序列及条件如下：ATQ3上游： 5’-TTGGTGGCCAAGTGTC-3’；ATQ3下游：5-’GTCTCTCCAGTGCATAGAT-3’；β-actin 上游：5’-TGTATGCCTCTGGTCGTACC-3’；β-actin下游：5’-CAGGTCCAGACGCAGGATG- 3’。反应条件：94℃预变性2min；94℃变性40s；62℃退火30s；72℃延伸20s；35个循环。
1.8统计学方法结果用One-way ANOVA t检验。
2结果
2.1小鼠皮肤的表观特征
实验结束后，观察各组小鼠皮肤外观特征，A组小鼠皮肤红润，光滑，充满弹性，表皮紧致，无皱纹。与A组相比，B组小鼠皮肤颜色黯淡无光，粗糙多褶皱，变得松弛、无弹性。 C组小鼠皮肤松弛情况有一定的改善，皱纹减少，但皮肤弹性仍较差，颜色暗淡无光。D组小鼠皮肤外观得到明显的改善。与模型组相比，皮肤变的细腻，恢复了一定的光泽，弹性明显有所恢复，褶皱减轻，松弛现象得到改善。
2.2对小鼠皮肤水分含量影响
与A组相比，B组和C组小鼠皮肤水分含量明显低于空白组(P＜0.01)，这说明皮下注射D-半乳糖会导致皮肤水分含量显著降低，涂抹10％尿素霜虽然能够在一定程度上提高皮肤水分含量，但仍为达到正常皮肤的水分含量。与B组相比，C组和D组小鼠皮肤水分含量均得到明显的提高，差异具有统计学意义(P＜0.05或P＜0.01)。
表1四种不同方法处理对小鼠皮肤水分的影响
注：与A组比较，△P＜0.05，△△P＜0.01；与B组比较，*P＜0.05，**P＜0.01。
2.3对小鼠皮肤羟脯氨酸含量影响
AQP是20世纪90年代发现的一类高度保守的膜整合蛋白，皮肤中主要分布的是AQP3 亚型。AQP3在表皮的基底层表达最明显，到角质层消失。这种空间分布与皮肤的水含量有关，基底层和基底层上部的水含量是75％，而角质层是10％～15％。本研究结果表明(表2)，与A组相比，B组小鼠皮肤中AQP3mRNA的表达量明显下降(P＜0.01)。与B组相比，C 组和D组小鼠皮肤中AQP3mRNA的表达量明显升高(P＜0.01)。AQP3的高表达，可将体内循环中的水分带入表皮，保证表皮持续的水含量。已经有研究证实，通过调节AQP3的表达及功能变化，可以改变鼠皮肤的含水量。
表2四种不同方法处理后AQP3mRNA表达量
注：与A组比较，△P＜0.05，△△P＜0.01；与B组比较，*P＜0.05，**P＜0.01。
综上所述，本研究结果表明本发明的药物组合物具有良好的皮肤保湿作用，其作用机制在于其能够显著上调小鼠皮肤AQP3mRNA的表达量(P＜0.01)。
实施例4
本研究通过观察本发明的药物组合物提取物对健康志愿者皮脂含量、角质层含水量的影响，在人体水平进一步验证本发明的药物组合物提取物的皮肤保湿能力，实验中所用的的乳液为实施例2制备的含有1％本发明药物组合物提取物乳液。
1.材料与方法
1.1测试对象的选择
本临床研究于2016年8月～2017年10月在广州紫和堂幸和中医门诊部开展，总共纳入 30名24～42岁的女性志愿者，纳入标准：女性，在广州本地居住5年以上；以室内工作为主，无高剂量日晒；测量部位无皮肤病或可以影响皮肤的全身性疾病；皮肤无光过敏史，无化妆品过敏史；对研究目的和内容知情同意，能按要求随访者。排除标准：已知对受试产品中的成分过敏者；精神病患者；处于怀孕期、哺乳期或分娩后半年内者；有严重肝肾疾病、自身免疫性疾病(如系统性红斑狼疮、类风湿关节炎)、HIV感染者：近12个月内被诊断为皮肤肿瘤并接受治疗者；正在使用和/或在试验前14天内口服或外用了试验禁用的药物(糖皮质激素、免疫抑制剂及抗过敏药)；正在使用或试验前1个月使用过其他同类产品者。
1.3测试仪器采用Sebumeter SM810皮脂测量仪(德国Courage Khazaka公司)测量皮肤表面皮脂含量，采用Corneumter CM820皮肤水分测量仪(德国Courage Khazaka公司)测量皮肤水分含量。皮脂含量和皮肤水分含量的单位均为au(arbitrary unit)。
1.4测试条件无阳光直射，无风，工作环境温度为22～24℃，相对湿度为50％～60％，测量前确认志愿者当天没有使用化妆品，志愿者清洁面部静息20分钟，使皮温与室内温度达到一致，以便利的姿势躺在床上，受测部位用玉兰油深度滋润香皂(广东宝洁公司)清洗前和清洗后1h，依次进行皮脂、水分的检测。
1.5涂抹方法测试对象连续使用30d，每天早晨、晚上睡前洗脸后在面部涂抹实施例6的化妆品配方制备的具有皮肤保湿作用的乳液(广州青岚生物科技有限公司制备)，涂抹量以略见涂抹层即可。测试部位应用皮脂分泌测试仪对患者双侧鼻翼部位进行皮脂分泌测定；应用角质层含水量测试仪对患者双侧颧骨最高部位进行角质层含水量测定，每个部位测10次，去掉最高值和最低值后取平均值。
1.6.安全性评价在复诊时对受试者进行不良反应评价，询问受试者靶部位原症状是否加重或出现新的皮损，如瘙痒、干燥、脱屑、刺痛、红肿、脱屑等症状及是否妨碍日常生活。重度：不良反应妨碍日常活动，受试者自觉症状显著，不能忍受，需要停用；中度：不良反应妨碍日常生活，受试者自觉症状明显，但可忍受，无须停用受试产品；轻度：可耐受不良反应，受试者偶能感受到。对出现不良反应的受试者，医生对其进行斑贴试验.以确定不良反应和试验产品的因果关系。负责医生认为受试者不适合继续试验，或受试者要求停止，即停止该受试者的试验，并记录停止原因和时间。
1.7.统计学处理采用SSPS 11.5软件进行自身前后配对t检验。
2.结果
2.1 30名志愿者使用前后皮肤皮脂含量和角质层含水量比较表2显示，比较试验前，30 名志愿者使用本发明的药物组合物30d后皮肤皮脂含量和角质层含水量均明显升高(P＜ 0.01)。
表2 使用前后30名志愿者皮肤皮脂含量和角质层含水量比较(au)
注：与使用前比较，*P＜0.05，**P＜0.01。
2.2产品安全性评估使用前后均未发生不良反应，无1例志愿者脱落。整个研究过程未发生与该试验产品相关的不良反应事件。
护肤品对皮肤的作用是通过皮肤水分含量的变化反映出来的，主要由皮肤保湿性实验完成，这是目前应用最广泛的皮肤测试手段之一。使用Corneometer法来评价成分是否具有保湿功能是一种具有高敏感性、重复性和适应性的客观评价方法。本临床研究结果表明(详见表2)，本发明的药物组合物能够显著增加志愿者皮质含量和角质层含水量(P＜0.05)，具有良好的皮肤保湿作用。
本发明并不限于上述实施方式，在不背离本发明的实质内容的情况下，本领域技术人员可以想到的任何变形、改进、替换均落入本发明的范围。
Claims (7)
1.具有皮肤保湿作用的药物组合物，其特征在于：是以小红参、倒挂金钩、天山雪莲、金莲花、大花红景天、纤花耳草和金佛山雪胆为原料制备的，且任一组分的重量百分含量均不超过总量的30％。
2.根据权利要求1所述的具有皮肤保湿作用的药物组合物，其特征在于，是以如下质量份数的原料制备的：小红参190～210份、倒挂金钩290～310份、天山雪莲140～160份、金莲花140～160份、大花红景天140～160份、纤花耳草140～160份、金佛山雪胆140～160份。
3.根据权利要求2所述的具有皮肤保湿作用的药物组合物，其特征在于，是以如下质量份数的原料制备的：小红参200份、倒挂金钩300份、天山雪莲150份、金莲花150份、大花红景天150份、纤花耳草150份、金佛山雪胆150份。
4.制备权利要求1所述的药物组合物的方法，包括如下步骤：
(1)将小红参190～210份、倒挂金钩290～310份、天山雪莲140～160份、金莲花140～160份、大花红景天140～160份、纤花耳草140～160份、金佛山雪胆140～160份混合均匀，用水作为溶剂提取，得到该药物组合物提取液；
(2)将所述药物组合物提取液浓缩，得到浓缩液，将所述药物组合物浓缩液上大孔树脂柱，用0.6～1.5倍柱体积的水进行洗脱，得到第一洗脱液；
(3)将所述第一洗脱液上强酸型阳离子交换树脂柱，用水洗脱至水洗脱液无糖反应，再用2～8wt％氨水溶液洗脱5倍柱体积至颜色明显变浅，收集所述氨水溶液的洗脱液作为第二洗脱液；
(4)将所述第二洗脱液浓缩，干燥，得到所述药物组合物提取物。
5.根据权利要求1～3任一项所述的具有皮肤保湿作用的药物组合物，其特征在于，所述药物组合物还包含制剂学上可接受的载体和/或赋形剂，用于制备皮肤保湿的化妆品，如面膜、爽肤水、面霜、乳液、凝胶。
6.根据权利要求3所述的药物组合物，其特征在于，所述制剂学上可接受的载体和/或赋形剂选自卡波姆、羧甲基纤维素钠、甘油、羟丙基-β-环糊精、丙二醇、山梨醇、聚氧乙烯氢化蓖麻油HS15中的一种或多种。
7.根据权利要求1～5任一项所述的药物组合物，其特征在于，所述组合物的应用为用于制备皮肤保湿的化妆品，如面膜、爽肤水、面霜、乳液、凝胶。
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