CN117503849A - 一种防治脱发的外用中药组合物及其制备方法和用途 - Google Patents
一种防治脱发的外用中药组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种防治脱发的外用中药组合物及其制备方法和用途。所述中药组合物由8种根据中国法规可以在化妆品中添加使用的原料艾叶、菊花、九节茶、荆芥、防风、薄荷、藿香、甘松组成。该组合物能够通过抑制头皮有害菌,减少头皮屑;改善头皮水油平衡,减少头皮油脂过度分泌;抗炎,改善头皮炎症状态,减轻头皮瘙痒;促进毛发生长,改善脱发。本发明外用中药组合物制备方法简单,并且可以将其方便地添加到头皮外用药物、头皮护理精华、洗发水等产品形式中,以方便消费者使用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种防治脱发的外用中药组合物及其制备方法和用途。
背景技术
脱发即头发脱落,包括生理性脱落和病理性脱落两种。生理状态下头皮毛囊呈周期性生长,分为生长期、衰退期和休止期。正常情况下,进入衰退期和休止期与进入生长期的毛发是处于相对平衡状态的,每日脱发100-150根是正常的生理代谢,称为生理性脱发。但由于药物副作用、环境因素、精神因素、产后等原因破坏了头发的正常生长周期,平衡状态被打破,脱发数目远远超过正常值,就成为病理性脱发。脱发分为很多类型,最常见的为雄激素性脱发与斑秃。
雄激素性脱发是起始于青春期或青春期后期的一种进行性毛囊微小化的脱发疾病,男女均可罹患,但表现为不同的脱发模式和患病率,在我国,男性患病率约为21.3%,女性患病率约为6.0%。雄激素性脱发的治疗方法包括系统用药、局部用药、毛发移植术、低能量激光治疗等。药物治疗中,非那雄胺仅适用于男性患者,用药1年后的有效率可达65%-90%,个别服药患者可出现前列腺特异性抗原减少、男性乳房发育、睾丸疼痛、过敏反应、性功能受损;螺内酯,仅适用于部分女性患者,至少服用1年才会有效,主要不良反应为月经紊乱、性欲降低、乳房胀痛等;米诺地尔为外用药物,男性推荐使用5%浓度,女性推荐2%浓度,平均见效时间为6-9个月,有效率可达50%-85%,个别用药患者可能出现多毛症、刺激性和过敏性皮炎等,停药后即可消退。
斑秃是一种常见的炎症性非瘢痕性脱发,可发生于任何年龄,中青年多见,无明显的性别差异,轻症患者大部分可自愈,约半数患者反复发作,可迁延数年或数十年。治疗上,外用糖皮质激素,是轻中度斑秃的主要外用药物,治疗3-4个月后仍未见疗效,应调整治疗方案,不良反应主要为皮肤萎缩变黄、毛细血管扩张、毛囊炎及色素减退等,停药后大部分可缓解;皮损内注射糖皮质激素,为脱发面积较小的稳定期患者首选治疗方法,3个月内仍无毛发生长,即应停止注射,不良反应主要为局部皮肤萎缩、毛囊炎及色素减退等,大部分可自行缓解;局部免疫疗法,可用于重型患者,适用于病程长及其他治疗效果不佳者,应至少坚持治疗3-6个月后评价疗效,有效率大约为30%-50%,不良反应较多,主要为接触性皮炎、淋巴结增大、色素沉着、发热和白癜风等。
传统中医将脱发称之为“虫蛀脱发”、“蛀发癣”、“油风”等,认为多与肝肾不足,气血两虚,腠理不固,风邪乘虚而入,风盛血燥,发失所养,或情志不遂,气血失和,阻塞血路,血不养发所致。中医多采用补肾、养血、活血及凉血法。除养血生发胶囊、斑秃丸等口服药物内治外,中药外治法在治疗脱发上也是历史悠久,临床上常将外治法与内治法结合,此外也可制成酊剂涂于患处按摩,或煎汤浸泡和熏洗头发。
中国专利202010604636.X公开了一种防治脂溢性脱发的中药洗剂,主要原料有苦参、白芷、牛蒡子、防风、地肤子、女贞子、当归、续断、何首乌、墨旱莲、肉桂、厚朴、补骨脂、草乌、牛膝、白芍、桑叶、陈皮、艾草、菊花、藁本、荆芥穗、藿香、甘松。制备方法为将前述主要原料加水熬制、过滤、静止,取上清液加入椰油酰胺丙基甜菜碱等其他成分做成洗头膏。中国专利202210714479.X公开了一种控油防脱组合物,包括姜根、女贞子、地黄根、何首乌、芝麻、人参根、鳢肠、侧柏叶,二氨基嘧啶氧化物、腺苷。制备方法包括以下步骤,加水提取、过滤、浓缩。中国专利202210783845.7公开了一种生发治疗脱发的中药组合物,包括绞股蓝、黄芪、桑叶、覆盆子、当归、白芍、桂枝、地龙、土元、羌活、苍术、麻黄、马钱子。制备工艺为粉碎、乙醇浸提、浓缩,再加入辅料,制成外用方剂。中国专利202211045464.5公开了一种防脱发外用中药组合物及其制备方法,组成为苦参、白鲜皮、地肤子、侧柏叶、桑叶、土茯苓、百部、半夏、石菖蒲、苍术、川芎、当归、鸡血藤、红花、牡丹皮、赤芍、紫草、防风、羌活、蔓荆子、白芷、车前草、泽泻、墨旱莲、何首乌、柴胡、桂枝、干姜、花椒、补骨脂、仙灵脾、甘草、薄荷。其制备方法为一定浓度酒精浸提而得。然而,上述制备方法不同程度的存在使用药味较多、制备工艺复杂、效果不佳和起效较慢等问题。
因此,目前市场上对于效果好、起效快、制备工艺简单和成本较低的用于防治脱发的中药外用制剂仍有较大需求。
发明内容
本发明的目的是为了解决现有技术的不足,针对脱发的中医发病机制,提供了一种防治脱发的外用中药组合物及其制备方法和用途。所述中药组合物由8种根据中国法规可以在化妆品中添加使用的原料组成。该组合物能够通过抑制头皮有害菌,减少头皮屑;改善头皮水油平衡,减少头皮油脂过度分泌;抗炎,改善头皮炎症状态,减轻头皮瘙痒;促进毛发生长,改善脱发。本发明外用中药组合物制备方法简单,并且可以将其方便地添加到头皮外用药物、头皮护理精华、洗发水等产品形式中,以方便消费者使用。
具体地,通过以下几个方面的技术方案实现了本发明:
在第一个方面中,本发明提供了一种防治脱发的外用中药组合物,以重量份数计,所述中药组合物包含艾叶2-8份,菊花2-8份、九节茶2-8份、荆芥2-8份、防风2-8份、薄荷4-16份、藿香2-8份、甘松2-8份。
作为可选的方式,在上述外用中药组合物中,以重量份数计,所述中药组合物包含艾叶4-6份,菊花4-6份、九节茶4-6份、荆芥4-6份、防风4-6份、薄荷8-12份、藿香4-6份、甘松4-6份。
作为可选的方式,在上述外用中药组合物中,以重量份数计,所述中药组合物包含艾叶6份,菊花6份、九节茶6份、荆芥6份、防风6份、薄荷12份、藿香6份、甘松6份。
作为可选的方式,在上述外用中药组合物中,所述中药组合物由艾叶、菊花、九节茶、荆芥、防风、薄荷、藿香和甘松制成。
艾叶是菊科蒿属植物,全草入药,具有温经、祛湿、散寒、止血、消炎、平喘、止咳、安胎等多种功效,外用可以祛湿止痒。
菊花为菊科植物菊的干燥头状花序,具有散风清热、平肝明目、清热解毒的作用。
九节茶为金栗兰科草珊瑚属植物草珊瑚的地上部分。具有祛风活血、清热解毒的功能。
荆芥为唇形科植物荆芥的干燥地上部分。具有解表散风,透疹,消疮的功能。
防风为伞形科植物防风的干燥根。具有祛风解表,渗湿止痛,止痉的功能。
薄荷为唇形科植物薄荷的干燥地上部分。具有疏散风热,清利头目,利咽,透疹,疏肝行气的功能。
藿香为唇形科藿香属藿香的干燥全草。具有祛暑解表,化湿和胃的功能。
甘松为败酱科植物甘松的干燥根及根茎。具有理气止痛,开郁醒脾;外用祛湿消肿的功能。
在第二个方面中,本发明还提供了上述第一个方面所述的外用中药组合物的制备方法,所述制备方法包括以下步骤:
(1)按比例称取艾叶、菊花、九节茶、荆芥、防风、薄荷、藿香、甘松,粗碎备用;
(2)将药材粗粉放入水蒸气蒸馏提取装置中,加入10-20倍药材量的水,浸泡过夜,使药材完全吸水浸润;
(3)加热至沸腾,后调低加热温度至80℃-100℃并保持4-8小时,收集冷凝液,得芳香水;
(4)药渣过滤,收集滤液,得提取液。
作为可选的方式,在上述制备方法中,所述制备方法包括以下步骤:
(1)按比例称取艾叶、菊花、九节茶、荆芥、防风、薄荷、藿香、甘松,粗碎备用;
(2)将药材粗粉放入水蒸气蒸馏提取装置中,加入16倍药材量的水,浸泡过夜,使药材完全吸水浸润;
(3)加热至沸腾,后调低加热温度至85℃并保持6小时,收集冷凝液,得芳香水;
(4)药渣过滤,收集滤液,得提取液。
作为可选的方式,在上述制备方法中,在所述外用中药组合物中,以重量百分比计,所述芳香水的添加量为10-80%,所述提取液的添加量为10-80%。
作为可选的方式,在上述制备方法中,在所述外用中药组合物中,以重量百分比计,所述芳香水的添加量为30-60%,所述提取液的添加量为30-60%。
作为可选的方式,在上述制备方法中,在所述外用中药组合物中,以重量百分比计,所述芳香水的添加量为45%,所述提取液的添加量为55%。
在第三个方面中,本发明提供了上述第一个方面所述的外用中药组合物或者采用上述第二个方面所述的制备方法制备得到的外用中药组合物在制备用于防治脱发的外用产品中的用途。
作为可选的方式,在上述用途中,所述外用产品为药物、化妆品或洗护产品。
作为可选的方式,在上述用途中,所述外用产品为凝胶剂、软膏剂、乳膏剂、泡沫剂、洗发水、护发素或喷雾型液体制剂。
作为可选的方式,在上述用途中,所述脱发为雄激素性脱发、神经性脱发、内分泌脱发、营养性脱发、物理性脱发、化学性脱发、感染性脱发、先天性脱发和季节性脱发中的一种或多种。
作为可选的方式,在上述用途中,所述外用产品提高毛囊组织活性,促使休止期的毛囊进入再生周期,促进毛发生长。
应理解,在本发明范围内中,本发明的上述各技术特征和在下文(如实施例)中具体描述的各技术特征之间都可以互相组合,从而构成新的或优选的技术方案。限于篇幅,在此不再一一赘述。
本发明相对于现有技术,具有以下有益效果:
(1)本发明是基于中医对脱发发病机制的理论发明的一种成分易得、安全性高的外用中药组合物。
(2)本发明外用中药组合物能够通过抑制头皮有害菌,减少头皮屑;改善头皮水油平衡,减少头皮油脂过度分泌;抗炎,改善头皮炎症状态,减轻头皮瘙痒;促进毛发生长,改善脱发。
(3)本发明外用中药组合物制备方法简单,并且可以将其方便地添加到头皮外用药物、头皮护理精华、洗发水等产品形式中,以方便消费者使用。
具体实施方式
以下对本发明的优选实施例进行说明,应当理解,此处所描述的优选实施例仅用于说明和解释本发明,并不用于限定本发明。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可通过正规渠道购买得到的常规产品。
制备实施例:
实施例1
一种防治脱发的外用中药组合物中,以重量份数计,所述中药组合物由艾叶6份,菊花6份、九节茶6份、荆芥6份、防风6份、薄荷12份、藿香6份、甘松6份制成。
所述制备方法包括以下步骤:
(1)按比例称取艾叶、菊花、九节茶、荆芥、防风、薄荷、藿香、甘松,粗碎备用;
(2)将药材粗粉放入水蒸气蒸馏提取装置中,加入16倍药材量的水,浸泡过夜,使药材完全吸水浸润;
(3)加热至沸腾,后调低加热温度至85℃并保持6小时,收集冷凝液,得芳香水;
(4)药渣过滤,收集滤液,得提取液。
在上述外用中药组合物中,以重量百分比计,所述芳香水的添加量为45%,所述提取液的添加量为55%。
实施例2
本实施例提供了一种防治脱发的洗发水,按重量百分比添加,包括以下组分:
实施例1所得的外用中药组合物60%、月桂醇聚醚硫酸酯钠16.5%、椰油酰胺丙基甜菜碱5%、椰油基葡糖苷4%、椰油酰胺2.5%、甘油2%、聚季铵盐-71%、香精0.8%、PEG-7甘油椰油酸酯0.5%、糖基海藻糖0.5%、甜菜碱0.5%、氯化钠0.3%、乙内酰脲0.3%。
上述洗发水的加工方法为:将固体原料溶解过滤,滤液与其他液体原料一起加入到组合物的提取物和芳香水中,置于乳化罐中搅拌混匀、均质后,分装即得。
对照例1
本对照例按照实施例1的方法进行制备,区别在于制备原料中以蔓荆子6份替代九节茶6份。
对照例2
本对照例按照实施例1的方法进行制备,区别在于制备原料中以蔓荆子6份替代九节茶6份,薄荷用量为6份。
对照例3
本对照例按照实施例1的方法进行制备,区别在于制备原料中以蔓荆子6份替代九节茶6份,薄荷用量为6份,添加藁本6份。
对照例4
本对照例按照实施例1的方法进行制备。但是,在所述外用中药组合物中仅使用芳香水。
对照例5
本对照例按照实施例1的方法进行制备。但是,在所述外用中药组合物中仅使用提取液。
效果实施例:
试验例1:
本试验例的目的为探究前述实施例1制备得到的外用中药组合物中的芳香水和提取液对马拉色菌抑制效果,以此判断去屑功效能力。
试验方法:
1)菌种预培养,制成染糠秕马拉色菌平板。
2)分别取芳香水和提取液滴加到无菌滤纸片,自然干燥。
3)用镊子将滤纸片贴放于染糠秕马拉色菌平板上。
4)贴放好的染糠秕马拉色菌平板放入培养箱,在30摄氏度温度下培养3-7天。
5)用直尺测量对染糠秕马拉色菌的抑制环直径。
结果判定依据:
试验样品的抑菌环直径大于7mm,具有抑菌效果,判定试验样品具有去屑功效;抑菌环直径不大于7mm,不具有抑菌作用,判定试验样品没有去屑功效。
结果:
前述组合物的芳香水、提取物的抑菌环直径均大于7mm,芳香水和提取物有抑菌的效果,判定前述组合物经水蒸气蒸馏制备工艺得到的芳香水和提取物均有去屑功效。并且,发现将芳香水与提取物组合使用后,抑菌环的直径显著增加,提示将芳香水与提取物组合后其在抑菌效果方面可能产生了显著的协同增效作用。
试验例2:
招募自述存在头发油腻、头皮屑、头皮瘙痒和脱发的健康成人,进行60次梳发法,脱发计数大于10根的参加产品试用,每组10人,分别用实施例1、对照例1、对照例2、对照例3、对照例4、对照例5按照实施例2中所述的方法制备的洗发水洗头,隔日1次,持续12周。
在使用前、使用后4周、8周、12周对油腻感、头皮屑、头皮瘙痒程度等进行自我体感评价,并进行60次梳发法,计算脱发数量。试用结束后,60次梳发法,脱发数量小于10根,几乎无油腻感、头皮屑、头皮瘙痒症状,为痊愈;相比初始,脱发数量减少一半及以上,油腻感、头皮屑减少明显,瘙痒明显减轻为显效;脱发数量减少三分之一,油腻感及头皮屑有所减少,瘙痒有所减轻为有效;脱发数量减少不明显,油腻感、头皮屑基本无变化,瘙痒无明显变化为无效,总有效率=(痊愈+显效+有效)/总例数×100%。
表1:各组试用人群脱发数量改善情况
如表1中的结果所示,从脱发数量改善情况来看,本发明所提供的以特定比例的提取液和芳香水制成的外用中药组合物配制的洗发水相比2个仅使用芳香水或提取液的对照例(对照例4和对照例5)能更有效减少脱发数量,实施例1的总有效率可达100%,可见芳香水和提取液的成分针对脱发可能产生了显著的协同增效作用。
另外,从对照例1-对照例3的数据可以看出,当增减、替换本发明外用中药组合物中的某些组分或改变其用量比例后,所述外用中药组合物的疗效显著变差,因此说明中药组合物中各药味的种类以及用量比例对于本发明外用中药组合物的疗效均是至关重要的。
表2:各组试用人群油腻感改善情况
组别 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
实施例1 | 4(40%) | 4(40%) | 2(20%) | 0 | 10(100%) |
对照例1 | 1(10%) | 4(40%) | 3(30%) | 2(20%) | 8(80%) |
对照例2 | 0 | 4(40%) | 4(40%) | 2(20%) | 8(80%) |
对照例3 | 0 | 3(30%) | 4(40%) | 3(30%) | 7(70%) |
对照例4 | 1(10%) | 4(40%) | 3(30%) | 2(20%) | 8(80%) |
对照例5 | 0 | 3(30%) | 4(40%) | 3(30%) | 7(70%) |
如表2中的结果所示,从油腻感改善情况来看,本发明所提供的以特定比例的提取液和芳香水制成的外用中药组合物配制的洗发水相比2个仅使用芳香水或提取液的对照例(对照例4和对照例5)能更有效减少油腻感,实施例1的总有效率可达100%,可见芳香水和提取液的成分的去油作用可能产生了显著的协同增效作用。
另外,从对照例1-对照例3的数据可以看出,当增减、替换本发明外用中药组合物中的某些组分或改变其用量比例后,所述外用中药组合物的疗效显著变差,因此说明中药组合物中各药味的种类以及用量比例对于本发明外用中药组合物的疗效均是至关重要的。
表3:各组试用人群头皮屑改善情况
组别 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
实施例1 | 8(80%) | 2(20%) | 0 | 0 | 10(100%) |
对照例1 | 4(40%) | 3(30%) | 2(20%) | 1(10%) | 9(90%) |
对照例2 | 3(30%) | 3(30%) | 3(30%) | 1(10%) | 9(90%) |
对照例3 | 4(40%) | 3(30%) | 1(10%) | 2(20%) | 8(80%) |
对照例4 | 5(50%) | 3(30%) | 1(10%) | 1(10%) | 9(90%) |
对照例5 | 3(30%) | 4(40%) | 1(10%) | 2(20%) | 8(80%) |
如表3中的结果所示,从头屑改善情况来看,各试验组对试用人群的头皮屑均有良好的改善作用,各试验组的总有效率均在80%以上。
本发明所提供的以特定比例的提取液和芳香水制成的外用中药组合物配制的洗发水相比2个仅使用芳香水或提取液的对照例(对照例4和对照例5)能更有效减少头皮屑,实施例1的总有效率可达100%,可见芳香水和提取液的成分的去屑作用可能产生了显著的协同增效作用。并且,可以看出芳香水成分的去屑作用可能优于提取液成分。
另外,从对照例1-对照例3的数据可以看出,当增减、替换本发明外用中药组合物中的某些组分或改变其用量比例后,所述外用中药组合物的疗效显著变差,因此说明中药组合物中各药味的种类以及用量比例对于本发明外用中药组合物的疗效均是至关重要的。
表4:各组试用人群头皮瘙痒改善情况
组别 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
实施例1 | 10(100%) | 0 | 0 | 0 | 10(100%) |
对照例1 | 6(60%) | 4(40%) | 0 | 0 | 10(100%) |
对照例2 | 6(60%) | 3(30%) | 1(10%) | 0 | 10(100%) |
对照例3 | 6(60%) | 4(40%) | 0 | 0 | 10(100%) |
对照例4 | 8(80%) | 2(20%) | 0 | 0 | 10(100%) |
对照例5 | 6(60%) | 3(30%) | 1(10%) | 0 | 10(100%) |
如表4中的结果所示,从头皮瘙痒改善情况来看,各试验组对试用人群的头皮瘙痒均有良好的改善作用,各试验组的总有效率均为100%。
本发明所提供的以特定比例的提取液和芳香水制成的外用中药组合物配制的洗发水相比2个仅使用芳香水或提取液的对照例(对照例4和对照例5)能更有效地改善头皮瘙痒,实施例1的痊愈率为100%,可见芳香水和提取液的成分的改善头皮瘙痒作用可能产生了显著的协同增效作用。并且,可以看出芳香水成分的改善头皮瘙痒作用可能优于提取液成分。
另外,从对照例1-对照例3的数据可以看出,当增减、替换本发明外用中药组合物中的某些组分或改变其用量比例后,所述外用中药组合物的疗效显著变差,因此说明中药组合物中各药味的种类以及用量比例对于本发明外用中药组合物的疗效均是至关重要的。
显然,本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。
Claims (9)
1.一种防治脱发的外用中药组合物,其特征在于:以重量份数计,所述中药组合物包含艾叶2-8份,菊花2-8份、九节茶2-8份、荆芥2-8份、防风2-8份、薄荷4-16份、藿香2-8份、甘松2-8份。
2.根据权利要求1所述的外用中药组合物,其特征在于:以重量份数计,所述中药组合物包含艾叶4-6份,菊花4-6份、九节茶4-6份、荆芥4-6份、防风4-6份、薄荷8-12份、藿香4-6份、甘松4-6份。
3.权利要求1或权利要求2所述的外用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:
(1)按比例称取艾叶、菊花、九节茶、荆芥、防风、薄荷、藿香、甘松,粗碎备用;
(2)将药材粗粉放入水蒸气蒸馏提取装置中,加入10-20倍药材量的水,浸泡过夜,使药材完全吸水浸润;
(3)加热至沸腾,后调低加热温度至80℃-100℃并保持4-8小时,收集冷凝液,得芳香水;
(4)药渣过滤,收集滤液,得提取液。
4.根据权利要求3所述的制备方法,其特征在于:在所述外用中药组合物中,以重量百分比计,所述芳香水的添加量为10-80%,所述提取液的添加量为10-80%。
5.权利要求1或权利要求2所述的外用中药组合物或者采用权利要求3或权利要求4所述的制备方法制备得到的外用中药组合物在制备用于防治脱发的外用产品中的用途。
6.根据权利要求5所述的用途,其特征在于:所述外用产品为药物、化妆品或洗护产品。
7.根据权利要求5所述的用途,其特征在于:所述外用产品为凝胶剂、软膏剂、乳膏剂、泡沫剂、洗发水、护发素或喷雾型液体制剂。
8.根据权利要求5所述的用途,其特征在于:所述脱发为雄激素性脱发、神经性脱发、内分泌脱发、营养性脱发、物理性脱发、化学性脱发、感染性脱发、先天性脱发和季节性脱发中的一种或多种。
9.根据权利要求5所述的用途,其特征在于:所述外用产品提高毛囊组织活性,促使休止期的毛囊进入再生周期,促进毛发生长。
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