CN116270855B - 一种治疗脱发的中药组合物 - Google Patents
一种治疗脱发的中药组合物 Download PDFInfo
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- CN116270855B CN116270855B CN202310167522.XA CN202310167522A CN116270855B CN 116270855 B CN116270855 B CN 116270855B CN 202310167522 A CN202310167522 A CN 202310167522A CN 116270855 B CN116270855 B CN 116270855B
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Abstract
本发明涉及一种治疗脱发的中药组合物，该中药组合物由以下重量份的中药制备而成：20‑40重量份的生侧柏、20‑40重量份的桑叶、20‑40重量份的旱莲草、5‑25重量份的蔓荆子、5‑25重量份的菟丝子、5‑25重量份的当归、1‑20重量份的薄荷、5‑25重量份的鸡冠花和20‑40重量份的丹参。本发明治疗脱发的中药组合物配伍合理，配制方法简单，成本低，口服或外用均对脱发具有确切的治疗效果，可减少毛发脱落量，加快毛发的生长速度，安全性高，鲜有不良反应发生，具有广阔的临床应用前景。
Description
技术领域
本发明涉及中药领域，具体涉及一种治疗脱发的中药组合物。
背景技术
脱发是指由遗传、免疫、应激、服用某些药物、内分泌失调等因素导致头发的非正常脱落，造成头发稀疏或形成秃发斑。脱发的类型很多，包括雄激素性秃发、精神性脱发、斑秃、先天性秃发/少毛症等。其中，雄激素性脱发及脂溢性脱发最为常见。脱发不仅仅是一种躯体性的皮肤疾病，还会影响患者的容貌美观，影响患者的心理精神健康。
近年来，国内外文献对于脱发诊疗相关的报道较多，一般根据脱发的分类，评估的严重程度及个体患者的差异选择合适的方案和药物，常见的治疗方法包括口服药物(非那雄胺、泼尼松/甲泼尼龙、B族维生素、辅酶Q、微量元素锌、免疫制剂、JAK等)、外用药物(米诺地尔、激素)、毛发移植、注射治疗、激光治疗等，但是治疗周期长，复发率高，长期使用安全性欠佳，费用较高等因素均限制了目前方法的应用。因此寻找一种安全有效、使用简便的治疗方法仍是当前亟须的研究方向。
中医对于脱发很早就有记载，《诸病源候论》云：“足少阴肾经也，其华在发，冲任之脉为十二经之海，谓之血海，其别络上唇口，若血盛则荣于须发,故须发美，若血气衰弱，经脉虚竭，不能荣润故须发落”。由此可见，传统医学认为肝肾异常,精血亏虚于上与脱发的发病有着密切的联系。越来越多的研究表明，中医药治疗脱发性疾病具有独特的优势，中医疗法既重视整体观念，又重视局部治疗，治疗手段包括中药内服、外用、针灸等，副作用少、疗效显著，可大大提高患者依从性及治疗效果，受众人群广，可形成脱发的慢病管理有效方法之一。
目前已有治疗脱发的中药组方治疗效果均有限，因此从中药领域进一步发掘应用于治疗脱发的药物，为制定临床用药方案提供更加丰富的选择，成为亟待解决的技术问题。
发明内容
为解决上述技术问题，本发明包括以下几个方面：
本发明的第一方面是提供一种治疗脱发的中药组合物，所述中药组合物由以下中药制备而成：生侧柏、桑叶、旱莲草、蔓荆子、菟丝子、当归、薄荷、鸡冠花和丹参。
优选的，所述中药组合物由以下重量份的中药制备而成：20-40重量份的生侧柏、20-40重量份的桑叶、20-40重量份的旱莲草、5-25重量份的蔓荆子、5-25重量份的菟丝子、5-25重量份的当归、1-20重量份的薄荷、5-25重量份的鸡冠花和20-40重量份的丹参。
更优选的，所述中药组合物由以下重量份的中药制备而成：25-35重量份的生侧柏、25-35重量份的桑叶、25-35重量份的旱莲草、10-20重量份的蔓荆子、10-20重量份的菟丝子、10-20重量份的当归、5-15重量份的薄荷、10-20重量份的鸡冠花和25-35重量份的丹参。
最优选的，所述中药组合物由以下重量份的中药制备而成：30重量份的生侧柏、30重量份的桑叶、30重量份的旱莲草、15重量份的蔓荆子、15重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和30重量份的丹参。
优选的，所述中药组合物进一步包括药学上可接受的辅料。
优选的，所述中药组合物的剂型为液体制剂。
优选的，所述中药组合物为口服制剂或外用制剂。
更优选的，所述中药组合物的剂型为溶液剂、洗剂、酊剂或者搽剂。
本发明的第二方面是提供上述中药组合物的制备方法，所述制备方法包括以下步骤：称取处方量的生侧柏、桑叶、旱莲草、蔓荆子、菟丝子、当归、薄荷、鸡冠花和丹参，加入2-4倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得。
优选的，称取处方量的中药后加入3倍重量份的蒸馏水。
本发明的第三方面是提供上述中药组合物在制备治疗脱发的药物中的应用。
优选的，所述脱发选自脂溢性脱发、雄激素性脱发、弥漫性脱发、休止期脱发、产后脱发或斑秃。
更优选的，所述脱发为脂溢性脱发。
本发明的第四方面提供上述中药组合物在制备增加皮肤毛囊数量的药物中的应用。
本发明的第五方面提供上述中药组合物在制备降低人体内二氢睾酮和雌二醇含量的药物中的应用。
本发明选用的中药原料在本领域的常见药理功效如下：
生侧柏，味苦、涩、性微寒，归肺、肝、大肠经，具有凉血止血、清热利湿等功效，临床中用于治疗各种出血证，如呕血咯血、便血血痢、尿血崩漏等。药理研究表明，生侧柏有祛痰镇咳、抗菌等作用。
桑叶，性寒，味甘、苦，归肺、肝经，具有疏散风热、清肺润燥、清肝明目的功效，可治疗风热感冒，肺热燥咳，头晕头痛，目赤昏花等病症。药理研究认为，桑叶有清肺润燥、止咳、去热、化痰、祛头痛、降血糖、抗糖病等作用。
旱莲草，性凉，味甘、酸，归肝、肾经，具有补益肝肾，凉血止血的功效。临床中主要用于治疗肝肾不足，头晕目眩，吐血，咯血，衄血，外伤出血等。药理研究表明，旱莲草具有抑菌，保肝，抗诱变，止血作用。
蔓荆子，性微寒，味辛、苦，归膀胱、肝、胃经，具有疏散风热，清利头目的功效。临床中主要用于风热感冒头痛，齿龈肿痛，目赤多泪，目暗不明，头晕目眩等症。药理研究表明。蔓荆子药具有抗菌、镇痛、改善微循环等作用。
菟丝子，性温，味甘，归肝、肾经，具有滋补肝肾，固精缩尿，安胎，明目，止泻等作用。临床主要用于阳痿遗精、尿有余沥、遗尿尿频、腰膝酸软、目昏耳鸣、肾虚胎漏、胎动不安、脾肾虚泻，外治白癜风。药理研究表明，菟丝子有抗炎、降低血压，提高心肌收缩力，壮阳的作用。
当归，性温，味甘、辛，归肝、心、脾经，具有补血活血，调经止痛，润肠通便的作用。临床多用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡等症。药理研究表明，当归有强心、降脂、抗血栓、抗肿瘤、抗炎等作用。
薄荷，性凉，味辛，归肺、肝经，具有发汗解表的功效，主要治疗感冒发热，喉痛，头痛，目赤痛，肌肉疼痛，皮肤风疹搔痒，麻疹不透等症，此外对痈、疽、疥、癣、漆疮亦有效。药理研究表明，薄荷有抗病毒、杀菌止痒、抗刺激、止咳等作用。
鸡冠花，性凉，味甘、涩，归肝、大肠经，具有收敛止血，止带，止痢的功效。临床中多用于吐血，崩漏，便血，痔血，赤白带下，久痢不止等症。药理研究表明，鸡冠花具有抗氧化、延缓衰老、抗疲劳、增强免疫、抗滴虫等作用。
丹参，性微寒，味苦，归心、肝经，具有活血调经，祛瘀止痛，凉血消痈，清心除烦，养血安神的作用。临床中多用于治疗月经不调，经闭痛经，症瘕积聚，疮疡肿痛，心烦不眠，肝脾肿大，心绞痛等症。药理研究表明，丹参具有强心、扩血管、改善微循环、抗血栓、抗菌、保肝、促进组织修复、降血脂等作用。
本发明产生的技术效果：
1、本发明治疗脱发的中药组合物配伍合理，配制方法简单，成本低，便于脱发患者长期使用。
2、本发明治疗脱发的中药组合物口服或外用均对脱发具有确切的治疗效果，可减少毛发脱落量，加快毛发的生长速度。
3、本发明治疗脱发的中药组合物安全性高，鲜有不良反应发生，具有广阔的临床应用前景。
具体实施方式
下面结合实施例对本发明作更进一步的说明，但本发明的实施方式不限于此。下述实施例中所使用的实验方法如无特殊说明，均为常规方法。
实施例1
称取30重量份的生侧柏、30重量份的桑叶、30重量份的旱莲草、15重量份的蔓荆子、15重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和30重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得本发明中药组合物1。
实施例2
称取15重量份的生侧柏、15重量份的桑叶、30重量份的旱莲草、30重量份的蔓荆子、30重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和30重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得本发明中药组合物2。
实施例3
称取30重量份的生侧柏、30重量份的桑叶、15重量份的旱莲草、30重量份的蔓荆子、30重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和15重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得本发明中药组合物3。
实施例4
称取30重量份的生侧柏、30重量份的桑叶、15重量份的旱莲草、15重量份的蔓荆子、15重量份的菟丝子、15重量份的当归、10重量份的薄荷、30重量份的鸡冠花和30重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得本发明中药组合物4。
实施例5
称取15重量份的生侧柏、15重量份的桑叶、15重量份的旱莲草、15重量份的蔓荆子、30重量份的菟丝子、30重量份的当归、10重量份的薄荷、30重量份的鸡冠花和30重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得本发明中药组合物5。
对比例1(制首乌替换生侧柏)
称取30重量份的制首乌、30重量份的桑叶、30重量份的旱莲草、15重量份的蔓荆子、15重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和30重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得中药组合物对比例1。
对比例2(百部替换旱莲草)
称取30重量份的生侧柏、30重量份的桑叶、30重量份的百部、15重量份的蔓荆子、15重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和30重量份的丹参，加入3倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得中药组合物对比例2。
试验例1、本发明中药组合物对脂溢性脱发小鼠毛发生长的影响
1、试验方法
1.1、试验分组和给药
取雄性C57BL/6J小鼠180只，随机分成9组，分别为正常组、模型组、本发明中药组合物1-5组和对比例1-2组，每组20只。称取等量的松香和石蜡加热混匀，涂于小鼠正背部，待混合物冷却变硬后揭去脱毛。除正常组外，其余各试验组小鼠背部涂抹0.05％的睾酮溶液造模，每次0.1mL，正常组小鼠涂抹等容积的生理盐水，各试验组每日1次涂抹睾酮溶液或生理盐水，连续20天。
脱毛后第2天开始给药，本发明中药组合物1-5组和对比例1-2组分别给予本发明实施例1-5和对比例1-2制备得到的中药组合物，正常组、模型组给予等量的生理盐水，各试验组给药体积均为0.1mL，均匀涂抹于脱毛区，每日1次，连续20天。
1.2、毛囊数目观察
于首次给药后第10天和第20天，各试验组分别取5只小鼠，剪取脱毛区皮肤，进行HE染色。显微镜(×100)观察毛囊形态。每个样本随机选择10个视野(×100)进行观察，计算单位视野内平均毛囊数目。
1.3、激素水平测定
末次给药结束后第2天，各试验组分别取5只小鼠，剪取脱毛区皮肤。加PBS匀浆离心后，取上清液用ELISA法测定二氢睾酮(DHT)和雌二醇(E2)水平。
2、试验结果
2.1、毛囊数目变化
本发明中药组合物对给药后10天和20天小鼠皮肤毛囊数量的影响如下表1所示。
表1本发明中药组合物对小鼠皮肤毛囊数量的影响
| 试验组 | 10天后毛囊数量 | 20天后毛囊数量 |
| 正常组 | 75.6±5.2 | 79.4±4.8 |
| 模型组 | 30.8±4.4 | 28.6±3.7 |
| 实施例1 | 63.8±4.9 | 69.7±3.4 |
| 实施例2 | 52.4±5.1 | 50.3±4.6 |
| 实施例3 | 50.1±6.2 | 51.5±5.3 |
| 实施例4 | 48.2±3.9 | 47.2±4.1 |
| 实施例5 | 47.5±5.7 | 47.9±5.0 |
| 对比例1 | 38.7±4.1 | 40.3±4.7 |
| 对比例2 | 40.2±3.6 | 41.9±3.9 |
从上表1可以看出，与正常组比较，模型组小鼠毛囊数目显著减少，提示造模成功。与模型组比较，实施例1-5组小鼠毛囊数量均显著增加，对比例1-2组小鼠毛囊数量增加不显著，上述试验结果证实本发明中药组合物可显著抑制脂溢性脱发模型小鼠毛囊微型化。
2.2、激素水平测定
本发明中药组合物对小鼠皮肤中二氢睾酮和雌二醇含量影响如下表2所示。
表2本发明中药组合物对小鼠皮肤中激素水平的影响
从上表2可以看出，与正常组比较，模型组小鼠皮肤中二氢睾酮和雌二醇含量显著提高。与模型组小鼠相比，实施例1-5组小鼠皮肤中二氢睾酮和雌二醇含量显著降低，对比例1-2组小鼠皮肤中二氢睾酮和雌二醇含量降低不显著，上述试验结果证实本发明中药组合物可有效降低局部雄激素水平，尤其是二氢睾酮。因此，推测本发明中药组合物可能通过降低皮肤组织中雄激素二氢睾酮水平，防止毛发脱落。
试验例2、本发明中药组合物临床应用病例
本发明治疗脱发的中药组合物临床疗效明确，大量患者临床使用本申请实施例制备的中药组合物后，临床疗效明显，对治疗脂溢性脱发、斑秃、休止期脱发、产后脱发等不同类型脱发均有明显疗效，可以有效减少脱发数量，促进毛发的新生，加快毛发生长速度，以下选取部分代表性病例予以说明。
病例1：陈某，女30岁，因头皮毛发进行性减少1年就诊，曾不规律治疗，诊断为“脂溢性脱发”，脱发量缓解欠佳。就诊后施用本申请实施例1的中药组合物，口服，每天2次，每次100ml，共8周，洗头时外用，每周2-3次，脱发量明显减少，新生毛发明显增多。
病例2：卢某，男，35岁，因头皮油腻伴毛发减少3年就诊，曾诊断为“雄激素性脱发”。外用米诺地尔(2次/天，每次1ml)，口服非那雄胺(1mg/次，1次/天)，效果不佳。就诊后施用本申请实施例1的中药组合物，口服，每天2次，每次100ml，洗头时外用，每周3-5次，共12周，头皮油腻明显缓解，可见较多新生毛发。
病例3：李某某，男，13岁，因头皮片状脱发斑反复6月就诊，诊断为“斑秃”。外用卤米松每日1次控制不佳。就诊后予心理疏导，同时施用本申请实施例1的中药组合物，口服，每天1次，每次100ml，洗头时外用，每周2次，共10周，无新生脱发斑，原脱发斑处较多新生毳毛，生长均匀。
病例4：林某，女，29岁，因产后脱发1年就诊，诊断为“产后脱发”。外用域发生发液(2次/天，每次1ml)，脱发仍较多。就诊后施用本申请实施例1的中药组合物，口服，每天2次，每次100ml，洗头时外用，每周3次，共12周，头皮脱发明显减少，可见较多新生毛发。
虽然已经对本发明的具体实施方案进行了描述，但是本领域技术人员应认识到，在不偏离本发明的范围或精神的前提下可以对本发明进行多种改变与修饰。因而，本发明意欲涵盖落在附属权利要求书及其同等物范围内的所有这些改变与修饰。
Claims (8)
1.一种治疗脱发的中药组合物，其特征在于，所述中药组合物由以下重量份的中药制备而成：30重量份的生侧柏、30重量份的桑叶、30重量份的旱莲草、15重量份的蔓荆子、15重量份的菟丝子、15重量份的当归、10重量份的薄荷、15重量份的鸡冠花和30重量份的丹参。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物进一步包括药学上可接受的辅料。
3.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物的剂型为液体制剂。
4.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物为口服制剂或外用制剂。
5.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物的剂型为洗剂、酊剂或者搽剂。
6.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物的剂型为溶液剂。
7.权利要求1所述中药组合物的制备方法，其特征在于，所述制备方法包括以下步骤：称取处方量的生侧柏、桑叶、旱莲草、蔓荆子、菟丝子、当归、薄荷、鸡冠花和丹参，加入2-4倍重量份蒸馏水，大火煮沸后转小火煎煮60分钟，过滤，滤液浓缩至原始加入蒸馏水体积的1/3，即得。
8.权利要求1-6任一项所述中药组合物在制备治疗脱发的药物中的应用。
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| CN104491181A (zh) * | 2015-01-05 | 2015-04-08 | 哈尔滨乐泰药业有限公司 | 一种治疗脱发的中药组合物及其制备方法和应用 |
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