CN115337351B - 一种中药复配精油 - Google Patents
一种中药复配精油 Download PDFInfo
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Abstract
本发明公布了一种治疗脂溢性脱发的中药复配精油，属于中药制剂技术领域。本发明的治疗脂溢性脱发的中药复配精油由如下原料组成：加拿大一枝黄花(Solidago canadensis L)精油，蜀葵(Althaea rosea)精油，马缨丹(Lantana camara)精油。本发明的中药复配精油全方配伍合理，组分间协同发挥作用，具有很好的防脱生发效果，在控制脂溢性脱发患者的头油、头屑、头痒等伴随症状的同时，无过敏等不良反应，安全性高，可显著降低血清中睾酮水平，升高雌二醇水平，对由雄性激素引起的脂溢性脱发有很好的治疗作用。
Description
技术领域
本发明公布了一种治疗脂溢性脱发的中药复配精油，属于中药制剂技术领域。
背景技术
如今脱发、白发等头皮亚健康问题困扰了越来越多的都市人。据世界卫生组织统计数据显示，平均每6个中国人就有1个脱发症状，而脱发已经呈现出了低龄化的趋势。2017年阿里健康发布的《拯救脱发趣味白皮书》数据也显示：“90后”正以36.1％的占比，几乎逼平占比38.5％的“80后”。中国健康促进与教育协会此前公布的“中国脱发人群调查”数据显示，成年男性中平均每4人就有1名脱发者，其中以20至40岁男性为主，30岁左右发展最快，这比上一代人的脱发年龄提前了20年。
脂溢性脱发的发病机制通常包括性腺分泌失调和皮脂腺分泌异常；雄性激素睾丸酮在5α-还原酶的催化下将转变为二氢化睾丸酮激素(DHT)，随着DHT浓度升高，DHT进入细胞核使ATP(腺嘌呤核苷三磷酸)的生成受阻影响细胞能量代谢，导致毛囊细胞毛发的蛋白质合成受阻，毛母细胞失去活力开始角质化而成为休止期毛发，而进入休止期的毛发，大约3个月内就会脱落。若雄性激素水平过高，会刺激其靶器官皮脂腺细胞，使皮脂腺分泌功能亢进，或皮脂腺增生和皮脂分泌增多，或皮脂毛囊导管角化过度，毛囊壁上脱落的上皮细胞与皮脂混合栓塞在毛囊口内，引发炎症，毛囊遭受破坏，从而导致毛发脱落。
脂溢性脱发的又一因素是卵圆形糠秕孢子菌。卵圆形糠秕孢子菌是人体皮肤正常菌群之一，在促发因素影响下，在毛囊内大量繁殖。而卵圆形糠秕孢子菌的过度繁殖会导致阻塞的毛囊扩张，继而破裂，内容物释入组织而产生炎症。
脱发一症，属于中医学“斑秃”、“油风”、“蛀发癣”等病范畴，是皮肤科的常见病、多发病、难治病之一，临床上主要以斑秃、脂溢性脱发两种最为多见。中医认为脱发与肝、脾、肾三脏密切相关，以肝、肾、脾虚为本，以风湿热搏结为标。因此，肾精肝血不荣是脱发的重要发病机制，是脱发之本。其临床治疗难度大，治疗周期长。
卵圆形糠秕孢子菌是造成脂溢性脱发的诱因之一。卵圆形糠秕孢子菌是一类亲脂性很强的条件致病真菌。蜀葵(Althaea rosea)精油具有抗菌消炎的作用，能促进细胞再生，修护皮肤细胞组织，减轻炎症和肿胀的肌肤问题。加拿大一枝黄(Solidago canadensisL)具有一定的药用价值，其提取精油的主要成分为异大香叶烯和柠檬烯，制成的中药制剂化妆品，具有散热祛湿和止痒的功效。马缨丹(Lantana camara)精油的主要成分是印蒿酮，它可以用于抗菌抗病毒，用于处理皮炎、湿疹、瘙痒等问题，其气味清凉极具穿透力。
现治疗脂溢性脱发主要以口服非那雄胺、米诺地尔为主以及手术治疗。非那雄胺是临床治疗脂溢性脱发的5α-还原酶抑制剂，口服吸收良好并能很快降低血清中DHT的水平，阻止头皮毛囊变小，从而逆转脱发。但其会产生性功能减退、中重度抑郁、情绪紊乱及饮食异常等不良反应，且非那雄胺不适宜妇女和儿童使用，怀孕和哺乳期妇女禁用。此外，停药后易复发，难以维持疗效，非那雄胺临床试验及上市后已有引起男性乳房癌的报告；米诺地尔的作用机理是本品及其代谢产物硫酸米诺地尔可以扩张头皮下血管，改善毛囊周围的微循环，促使原有毛囊的肥大，从而促进毛发的生长。但由于面部和四肢部位的毛囊对米诺地尔高度敏感，会出现多毛症。且以根治本病，停药后极易复发；手术操作较为复杂，治疗周期长，术后恢复慢，成本高、有时供区还会留下明显瘢痕，影响原部位的美容、难以普及。
中药复方具有疗效确切、毒副作用小等优点。中医药对脂溢性脱发症的防治具有独特的疗效。从中药筛选防治脂溢性脱发症的处方，是防治脂溢性脱发症药物开发的一种新尝试。
发明内容
本发明的发明目的是提供一种治疗脂溢性脱发的中药复配精油。本发明的中药复配精油全方配伍合理，组分间协同发挥作用，具有很好的防脱生发效果，在控制脂溢性脱发患者的头油、头屑、头痒等伴随症状的同时，无过敏等不良反应，安全性高，可显著降低血清中睾酮水平，升高雌二醇水平，对由雄性激素引起的脂溢性脱发有很好的治疗作用。
本发明提供的技术方案如下：
一种治疗脂溢性脱发的中药复配精油，所述的加拿大一枝黄花精油，蜀葵精油，马缨丹精油的质量比为1-2∶1-2∶1-2，所述的中药复配精油在治疗脂溢性脱发中的应用，以及控制脂溢性脱发患者的头油、头屑、头痒等伴随症状的应用。
优选地，所述的加拿大一枝黄花精油，蜀葵精油，马缨丹精油的质量比为1∶1∶1。
本发明还提供了上述治疗脂溢性脱发的中药复配精油制备方法，包括如下步骤：
将加拿大一枝黄花精油，蜀葵精油和马缨丹精油混合均匀，即制得治疗脂溢性脱发的中药复配精油。
本发明还保护了所述的中药复配精油在由雄性激素引起的脂溢性脱发的应用。
与现有技术相比，本发明具有的有益效果是：
本发明全方配伍合理，组分间协同发挥作用，可显著降低血清中睾酮水平，升高雌二醇水平，并有效地抑制了卵圆形糠秕孢子的增殖，具有很好的防脱生发效果，在控制脂溢性脱发患者的头油、头屑、头痒等伴随症状的同时，无过敏等不良反应。此外，本发明的中药复配精油制备工艺简单，有利于产业化的实现。
附图说明
图1为小鼠在经本发明实施例1-7制备的中药复配精油(中药复方各组分配比不同)及米诺地尔搽剂给药后，于5天、10天、15天、20天、25天、30天计得的总脱落毛发数量。
图2为小鼠在经本发明实施例1、对比例1-6制备的中药复配精油及米诺地尔搽剂给药后，于5天、10天、15天、20天、25天、30天计得的总脱落毛发数量。
图3为小鼠在经本发明实施例1、对比例1-6制备的中药复配精油及米诺地尔搽剂给药后，于30天测得的睾酮浓度、雌二醇浓度水平变化图。
图4为小鼠在经本发明实施例1、对比例1-6制备的中药复配精油及米诺地尔搽剂给药后，于30天测得的睾酮浓度与雌二醇浓度的比值(T/E2)水平变化图。
图5为本发明实施例1-7制备的中药复配精油、米诺地尔搽剂及蒸馏水对照样品测得的抑菌环直径对比图。
图6为本发明实施例1、对比例1-6制备的中药复配精油、米诺地尔搽剂及蒸馏水对照样品测得的抑菌环直径对比图。
具体实施方式
实施例中中药复配精油的药效试验如下：
1.实验材料
1)实验动物：小鼠，雌雄各半，体重22-28g
2)试剂：3％的苦味酸溶液、丙酸睾丸酮、小鼠睾酮ELISA试剂盒、小鼠雌二醇ELISA试剂盒、米诺地尔搽剂(斯必申)、各实施例制得的中药复配精油
2.实验方法
1)丙酸睾丸酮注射剂的配制：称取10mg的丙酸睾丸酮，溶于100ml椰子油中，获得0.1mg/ml的丙酸睾丸酮溶液，经高压灭菌后，备用。
2)造模：于小鼠颈后皮下注射丙酸睾丸酮注射液(每10g小鼠注射0.01mg丙酸睾丸酮溶液)，每日一次，连续30天。
3)给药方式：造模的同时给药，每日一次，连续30天
3.观察指标
1)脱落毛发数量：用3％苦味酸溶液染色小鼠脱落的毛发。
2)血清中睾酮水平：末次给药禁食12h后，眼球取血1ml，静置2h后，离心，取血清，用ELISA试剂盒检测小鼠血清中的睾酮(T)水平。
3)血清中雌二醇水平：末次给药禁食12h后，眼球取血1ml，静置2h后，离心，取血清，用ELISA试剂盒检测小鼠血清雌二醇(E2)水平，
4)睾酮浓度与雌二醇浓度的比值(T/E2)：计算T/E2值
实施例中的抑菌环实验如下：
(1)抑菌片的制备：用无菌吸管吸取各实施例的中药复配精油5μL于无菌并干燥的滤纸片，并且涂抹均匀。
(2)阴性对照样片的制备：取无菌且干燥滤纸片，每片滴加无菌蒸馏水5μL，干燥后备用。
(3)试验菌的接种：用无菌棉拭子蘸取浓度为5×105cfu/mL～5×106cfu/mL卵圆形糠秕孢子悬液，在适宜的培养基平板表面均匀涂抹3次。每涂抹1次，平板转动60°，最后将棉拭子绕平板边缘涂抹一周。盖好平皿，置室温干燥5min。
(4)抑菌剂样片贴放：每次试验贴放1个染菌平板，每个平板贴放4片试验样片，1片阴性对照样片，共5片。用无菌镊子取样片贴放于平板表面。各样片中心之间相距25mm以上，与平板的周缘相距15mm以上。贴放好后，用无菌镊子轻压样片，使其紧贴于平板表面。盖好平皿，置37℃恒温培养箱，培养16h～18h观察结果。用游标卡尺测量抑菌环的直径(包括贴片)并记录。
各实施例中中药复配精油的使用方法如下：使用前用温水洗净小鼠毛皮，取中药复配精油20mg经清水稀释后涂抹于毛皮，并用手按摩3-5分钟。
米诺地尔(斯必申米诺地尔搽剂)使用方法：使用前用温水洗净小鼠毛皮，取米诺地尔搽剂1ml(含米诺地尔20mg)涂抹于毛皮，并用手按摩3-5分钟。
表1各实施例配方(重量份)
表2各对比例配方(重量份)
图1为小鼠在经本发明实施例1-7制备的中药复配精油(中药复方各组分配比不同)及米诺地尔搽剂给药后，于5天、10天、15天、20天、25天、30天计得的总脱落毛发数量。从图1可知，在30天处总脱落毛发数量：米诺地尔搽剂＞实施例4＞实施例5＞实施例6＞实施例7＞实施例3＞实施例2＞实施例1，即实施例1制备得到的中药复配精油防脱发效果明显优于实施例2-7及米诺地尔搽剂，说明加拿大一枝黄花精油，蜀葵精油，马缨丹精油的质量比为1∶1∶1时，组分间可协同发挥作用，达到最优效果。
图2为小鼠在经本发明实施例1、对比例1-6制备的中药复配精油及米诺地尔搽剂给药后，于5天、10天、15天、20天、25天、30天计得的总脱落毛发数量。从图2可知，在30天处总脱落毛发数量：米诺地尔搽剂＞对比例5＞对比例4＞对比例6＞对比例1＞对比例2＞对比例3＞对比例5＞实施例1，说明加拿大一枝黄花精油，蜀葵精油，马缨丹精油都是必不可少的成分，三组分的协同作用可有效地减少毛发脱落。
图3为小鼠在经本发明实施例1、对比例1-6制备的中药复配精油及米诺地尔搽剂给药后，于30天测得的睾酮浓度、雌二醇浓度水平变化图。从图5可知，睾酮浓度：实施例1＜对比例1＜对比例2＜对比例3＜对比例4＜对比例5＜对比例6＜米诺地尔搽剂，雌二醇浓度：实施例1＞对比例1＞对比例2＞对比例3＞对比例4＞对比例5＞对比例6＞米诺地尔搽剂，其结果与睾酮浓度趋势正好相反，说明实施例1防脱发效果最好，与其他对比例相比睾酮浓度有显著的下降，雌二醇浓度有明显的上升，脂溢性脱发从根本上得到治疗。
图4为小鼠在经本发明实施例1、对比例1-6制备的中药复配精油及米诺地尔搽剂给药后，于30天测得的T/E2水平变化图。从图4可知，T/E2：实施例1＜对比例1＜对比例2＜对比例3＜对比例4＜对比例5＜米诺地尔搽剂＜对比例6，其趋势与图3睾酮浓度趋势一致，实施例1的T/E2最低，其治疗脂溢性脱发效果最优。
图5为本发明实施例1-7制备的中药复配精油、米诺地尔搽剂及蒸馏水对照样品测得的抑菌环直径对比图。从图6可知，抑菌效果：实施例1＞实施例2＞实施例3＞实施例7＞实施例6＞实施例1＞实施例4＞米诺地尔搽剂＞蒸馏水，说明实施例1对卵圆形糠秕孢子菌的抑制效果最好。
图6为本发明实施例1、对比例1-6制备的中药复配精油、米诺地尔搽剂及蒸馏水对照样品测得的抑菌环直径对比图。从图6可知，抑菌效果：实施例5＞对比例1＞对比例3＞对比例2＞米诺地尔搽剂＞对比例5＞对比例6＞对比例4＞蒸馏水，说明实施例1对卵圆形糠秕孢子菌的抑制效果最好。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。
Claims (4)
1.一种治疗脂溢性脱发的中药复配精油，其特征在于其组成为：加拿大一枝黄花精油，蜀葵精油，马缨丹精油，质量比1-2∶1-2∶1-2。
2.根据权利要求1所述的一种治疗脂溢性脱发的中药复配精油，其特征在于，所述的加拿大一枝黄花精油，蜀葵精油，马缨丹精油的质量比为1∶1∶1。
3.根据权利要求1-2任一项所述的一种治疗脂溢性脱发的中药复配精油，其特征在于其制备方法包括如下步骤：将加拿大一枝黄花精油，蜀葵精油和马缨丹精油混合均匀，即制得治疗脂溢性脱发的中药复配精油。
4.如权利要求1所述的中药复配精油在制备治疗由雄性激素引起的脂溢性脱发的药物中的应用。
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