CN110624089A - 一种可生发育发的外用中药组合物及其制备方法 - Google Patents
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Abstract
本发明属于中药技术领域,具体涉及一种可生发育发的外用中药组合物及其制备方法和用途。本发明结合现代中药药理研究,以补中益气、活血生发为主,提供的新的生发育发外用中药组合物包含以下原料药:生姜,何首乌,侧柏叶,黑豆,透骨草,当归,红花,丹参,天麻,人参,土茯苓,陈皮,该中药组合物的制备中未使用工业产品,安全无毒,可适用于家庭使用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种可生发育发的外用中药组合物及其制备方法和用途。
背景技术
现代社会,随着生活方式的变化、生活节奏的加快,竞争日益激烈,同时环境污染和饮食结构的不健康,脱发人群逐渐增多。
脱发主要包括斑秃、脂溢性脱发、雄性激素源性脱发、精神性脱发、产后脱发等,脱发患者常常是由于某些因素致使毛发由生长期过早进入毛发生长的静止期,头发毛囊和毛球萎缩,由终毛变为细的毫毛而引起。脱发问题是皮肤科的常见疾病,也是不易根治的疾病。
目前对脱发病的治疗主要有几下几种:(1)激素治疗,激素调节剂有雄激素阻断剂及雌激素介导剂等,但这些药物价格较高,副作用相对较大,不易长期使用且不易根治;(2)毛发移植,效果良好,但治疗过程复杂,并发症高,费用昂贵;(3)中药治疗,根据中医理论,不同类型脱发采用的配方一般不同,外用疗程较长,口服或口服外用同时治疗容易因配伍不合理产生副作用,并可能加重肝肾损伤;(4)治疗脱发的洗发护发产品,化学成分复杂,含有化工产品,不易长期使用,能真正到达病灶患处的药物很有限。
发明内容
本发明的目的就是针对现有技术存在的缺陷,利用中医药理论,针对各类型脱发病症,进行辨证配伍组方,标本兼治,提供一种安全有效的生发育发外用中药组合物及制备方法和用途。
本发明的第一个目的在于提供一种新的生发育发外用中药组合物,该组合物包含以下原料药:生姜,何首乌,侧柏叶,黑豆,透骨草,当归,红花,丹参,天麻,人参,土茯苓,陈皮。
上述中药组合物包含以下重量份的原料药:生姜5-20份,何首乌5-15份,侧柏叶1-10份,黑豆1-10份,透骨草1-10份,当归1-6份,红花1-6份,丹参1-6份,天麻1-6份,人参1-6份,土茯苓1-6份,陈皮1-4份。
优选地,上述中药组合物包含以下重量份的原料药:生姜8-16份,何首乌6-12份,侧柏叶3-8份,黑豆3-8份,透骨草3-8份,当归2-4份,红花2-4份,丹参2-4份,天麻2-4份,人参2-4份,土茯苓2-4份,陈皮1-3份。
在一个具体的实施方案中,本发明的中药组合物包含以下重量份的原料药:生姜13份,何首乌9份,侧柏叶3份,黑豆3份,透骨草3份,当归2份,红花2份,丹参2份,天麻2份,人参2份,土茯苓2份,陈皮1份。
在一个具体的实施方案中,本发明的中药组合物包含以下重量份的原料药:生姜10份,何首乌8份,侧柏叶5份,黑豆5份,透骨草5份,当归3份,红花3份,丹参3份,天麻2份,人参2份,土茯苓2份,陈皮1份。
在一个具体的实施方案中,本发明的中药组合物包含以下重量份的原料药:生姜15份,何首乌10份,侧柏叶8份,黑豆5份,透骨草5份,当归4份,红花4份,丹参4份,天麻3份,人参3份,土茯苓3份,陈皮2份。
在一个具体的实施方案中,本发明的中药组合物中所述生姜为干生姜。
在一个具体的实施方案中,本发明的中药组合物中所述何首乌为制何首乌。
在一个具体的实施方案中,本发明的中药组合物中所述红花为其炮制品,如炒红花、红花炭、醋红花。
在一个具体的实施方案中,本发明的中药组合物中所述人参为红参或园参或野山参或生晒参或糖参。
在一个具体的实施方案中,本发明的中药组合物中所述当归为酒当归。
本发明辨证论治,以益气活血来治疗各种类型的脱发性疾病,不仅可以促进新陈代谢功能,促进发根营养吸收,而且可以活血化瘀和刺激毛囊生长。本发明中何首乌补血生发、侧柏叶生发乌发,为君药;生姜解表散寒控油、透骨草祛风除湿、红花活血通经、丹参活血祛瘀、当归活血行气、土茯苓杀虫除菌,共为臣药;黑豆、天麻、人参佐之益气之效;陈皮导气,引药下行,为使药。以上诸药合用,共凑补中益气、活血生发之功,起生发育发之功效。
(1)生姜
姜科植物姜Zingiber officinale Rosc.的新鲜根茎。辛,微温。归肺、脾、胃经。解表散寒,温中止呕,化痰止咳。用于风寒感冒,胃寒呕吐,寒痰咳嗽。
生姜含挥发油0.25%~3.0%,主要成分为姜醇、姜烯、水芹烯、莰烯、柠檬醛、芳樟醇、甲基庚烯酮、壬醛、d-龙脑等。尚含辣味成分姜辣素,分解则变成油状辣味成分姜烯酮和结晶性辣味成分姜酮、姜萜酮的混合物。又含天门冬素、哌啶酸-2以及谷氨酸、天门冬氨酸、丝氨酸、甘氨酸等。此外,尚含有树脂状物质及淀粉。
药理作用:生姜可用于消化系统、循环和呼吸系统等,具有促进胃液和游离盐酸分泌、止吐、调节肠张力、调节中枢和呼吸系统、抗菌抗原虫等作用。
(2)何首乌
蓼科植物何首乌Polygonum multiflorum Thunb.的块根。苦、甘、涩,微温。归肝、心、肾经。解毒,消痈,截疟,润肠通便。用于疮痈,瘰疬,风疹瘙痒,久疟体虛,肠燥便秘。制何首乌为何首乌的炮制品,其可补肝肾,益精血,乌须发,强筋骨。用于血虚萎黄,眩晕耳鸣,须发早白,腰膝酸软,肢体麻木,崩漏带下,久疟体虚。
主要含蒽醌类化合物,主要成分为大黄酚、大黄素、大黄素甲醚、大黄酸、芦荟大黄素,还含卵磷脂、粗脂肪等。
药理作用:何首乌中蒽醌类成分具有降血脂、抗动脉粥样硬化、抗菌、润肠通便、抗肿瘤及提高免疫力、抗衰老及促进学习记忆力能力等作用。制何首乌可使血液红细胞数及血红蛋白含量增高。
(3)侧柏叶
柏科植物侧柏PLatycladus orientalis(L.)Franco的干燥枝梢和叶。苦、涩,寒。归肺、肝、脾经。凉血止血,生发乌发。用于吐血衄血,咯血,便血,崩漏下血,血热脱发,须发早白。
侧柏叶含挥发油0.6~1%,中含侧柏烯、侧柏酮、小茴香酮、蒎烯、石竹烯等;黄酮类中有香橙素、槲皮素、杨梅树皮素、扁柏双黄酮、穗花杉双黄酮等。新鲜侧柏叶的粗制总黄酮含量为1.72%。还含鞣质、树脂、维生素C等。药理作用:明显缩短出血和凝血时间;提取物有镇静、祛痰作用;可以协同戊巴比妥钠的麻醉作用,有中枢镇静作用;能舒张离体肠段平滑肌;对多种细菌及某些病毒有抑制作用;对结核杆菌的生长有抑制作用。
(4)黑豆
豆科植物大豆Glycine max(L.)Merr.的干燥种子。甘,平。归脾、肾经。益精明目,养血祛风,利水,解毒。用于阴虚烦渴,头晕目昏,体虚多汗,肾虚腰痛,水肿尿少,痹痛拘挛,手足麻木,药食中毒。
黑豆含粗蛋白质34%,每100g黑豆含蛋白质最高可达49.8%,高于其他豆类。还含有粗纤维5%,含脂肪12%,其脂肪组成是棕榈酸2.4%~6.8%,硬脂酸4.4%~7.3%,花生油酸0.4%~1.0%,油酸23.0%~35.6%,亚油酸51.7%~57%亚麻酸2.0%~9.8%不饱和脂肪酸达86.1%。此外,黑豆还含有多种微量元素、维生素和强心苷、大豆皂苷等功能因子。
药理作用:降低人体血胆固醇含量,减少患心脏病的危险;清除自由基,延缓衰老;调理血脂蛋白,预防、治疗血脂升高;免疫调节功能;防癌、改善贫血。
(5)透骨草
大戟科地构叶属植物地构叶Speranskia tuberculata(Bunge)Baill.的全草。辛、苦,温。有小毒,归肝、肾经。祛风除湿,解毒止痛。用于风湿关节痛;外用治疮疡肿毒。
透骨草地上部分含黄酮成分:香叶木素、藤黄菌素、柚皮素-7-O-β-D-(3"-对香豆酰基)吡喃葡萄糖苷、柚皮素-7-O-β-D-(4"-对香豆酰基)吡喃葡萄糖苷、3',8"-双-4',5,7-三羟基黄酮。全草含吡啶生物碱成分。
药理作用:具有抗炎镇痛、抗菌、抗过敏、抗肿瘤等作用。
(6)当归
伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。甘、辛,温。归肝、心、脾经。补血活血,调经止痛,润肠通便。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。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。
当归中主要含挥发油部分:挥发油含量可达0.2%-0.4%,挥发油有酸性、酚性和中性三部分,含量分别为5.88%、3.46%和90.4%。挥发油中以藁木内酯的含量最高,约45%,正丁烯酜内酯约占11.3%,具有特异的芳香味。水溶性部分:含阿魏酸,丁二酸,烟酸,尿嘧啶,腺嘌呤,豆甾醇,D-葡萄糖苷,十四醇-1,香荚兰酸,钩吻荧光素。
药理作用:具有抗血栓形成、改善血液循环、改善冠脉循环、有扩张血管及对去甲肾上腺素(NA)所致血管痉挛有温和解痉、抗炎镇痛、降血糖、肺部保护等作用。
(7)红花
菊科植物红花Carthamus tinctorius L.的干燥花。辛,温。归心、肝经。活血通经,散瘀止痛。用于经闭,痛经,恶露不行,癥瘕痞块,胸痹心痛,瘀滞腹痛,胸胁剌痛,跌扑损伤,褡疡肿痛。
红花主要含红花苷、新红花苷、红花醌苷、红花素、红花黄色素、二十九烷、β-谷甾醇、棕榈酸、肉豆蔻酸、月桂酸、二棕榈酸、甘油酯、油酸、亚油酸,花中的挥发油主要成分为多炔类的混合物,其他还鉴定了85种成分。此外,红花中还含有木聚糖类,脂肪油、红花多糖及16种氨基酸,其中赖氨酸的含量为0.8%。
药理作用:红花有扩张血管、增加血流量、改善微循环和抑制血小板聚集等作用,对血栓性脑血管疾病有疗效,对脑梗塞动物的脑组织有保护作用。
(8)丹参
唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根和根茎。苦,微寒。归心、肝经。活血祛瘀,通经止痛,清心除烦,凉血消痈。用于胸痹心痛,脘腹胁痛,癥瘕积聚,热痹疼痛,心烦不眠,月经不调,痛经经闭,疮疡肿痛。
其主要化学成分有丹参酮、丹参酚酸类、挥发油及无机元素等。
药理作用:丹参具有保护血管内皮细胞、抗心律失常、抗动脉粥样硬化、改善微循环等作用。
(9)天麻
兰科植物天麻Gastrodia elata Blume.的干燥块茎。甘、平。归肝经。息风止痉,平抑肝阳,祛风通络,用于小儿惊风,疯癫抽搐,破伤风,头痛眩晕,手足不遂,肢体麻木,风湿痹痛。
其中药成分为天麻甙,也称天麻素,其化学组成为对-羟甲基苯-β-D-吡喃葡萄糖甙;另含天麻醚甙,其化学组成为双-(4-羟苄基)-醚-单-β-D-吡喃葡萄糖甙。
药理作用:具有镇静、抗惊厥、保护脑神经细胞、抗眩晕、降压、抗血小板聚集、抗血拴、抗炎、镇痛、抗心肌缺血、保护心肌细胞、改善记忆、延缓衰、增强免疫功能等。
(10)人参
五加科植物人参Panax ginseng C.A.Mey.的干燥根。甘、微苦,微温。归脾、肺、心、肾经。大补元气,复脉固脱,补脾益肺,生津养血,安神益智。用于体虚欲脱,肢冷脉微,脾虚食少,肺虚喘咳,津伤口渴,内热消渴,气血亏虚,久病虚羸,惊悸失眠,阳痿宫冷。
根中含人参皂甙0.4%,少量挥发油。油中主要成份为人参烯0.072%。还有皂甙、人参炔醇。此外尚含有单糖类、人参酸,多钟维生素,多种氨基酸、胆碱、酶,精胺。
药理作用:人参对中枢神经系统具有兴奋作用,而大量时反而有抑制作用;对心肌及血管有直接作用;加强机体对有害因素的抵抗力;对因肾上腺素引起的高血糖动物有降低血糖的作用;能促进动物的性腺功能;改善贫血等。
(11)土茯苓
百合科植物光叶菝葜Smilax glabra Roxb的干燥根茎。甘、淡,平。归肝、胃经。除湿,解毒,通利关节。用于湿热淋浊,带下,痈肿,瘰疬,疥癣,梅毒及汞中毒所致的肢体拘挛,筋骨疼痛。
根茎中含落新妇甙,黄杞甙,3-O-咖啡酰莽草酸,莽草酸,阿魏酸,β-谷甾醇,葡萄糖。
药理作用:具有抗肿瘤、棉酚的解毒作用。
(12)陈皮
芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。苦、辛,温。归肺、脾经。理气健脾,燥湿化痰。用于胸脘胀满,食少吐泻,咳嗽痰多。
陈皮含挥发油1.5%(压榨法)至2%(蒸馏法),油中主要成分为D-柠檬烯,还含β-月桂烯α-及β-蒎烯等,另含黄酮类成分橙皮甙、新橙皮甙、柑橘素、二氢川陈皮素及5-去甲二氢川陈皮素;又报道川陈皮含橙皮甙约8.4%,川陈皮素约0.15%.另含辛弗林(对羟福林)0.28%-2.54%.
药理作用:陈皮所含挥发油,对胃肠道有温和的刺激作用,可促进消化液的分泌,排除肠管内积气;陈皮煎剂、醇提物等能兴奋心肌,但剂量过大时反而出现抑制,还可使血管产生轻度的收缩,迅速升高血压,陈皮中的果胶对高脂饮食引起的动脉硬化也有一定的预防作用;陈皮所含挥发油有刺激性被动祛痰作用,使痰液易咯出;可使肾血管收缩,使尿量减少;陈皮煎剂与维生素C、维生素K并用,能增强消炎作用。
在一个具体的实施方案中,本发明的中药组合物,其中还包含可药用辅料。
本发明的中药组合物可以制成各种外用制剂,比如搽剂、纳米乳剂、凝胶剂、透皮贴剂、散剂、洗剂、气雾剂、喷雾剂、微乳凝胶剂、贴剂、脂质体凝胶剂、泡沫制剂。
在一个具体的实施方案中,本发明的中药组合物,其中还包含化妆品基质。
本发明的中药组合物可以制成各种化妆品,比如护发素、头发喷雾、洗发水、精华素、生发液。
本发明的另一目的,是制备本发明的中药组合物的方法。
本发明中药组合物可以这样制备:将上述原料药干燥研成粉末,混匀,得到有效成分。
本发明中药组合物还可以这样制备:
方法一:将上述原料药水提,得所述中药组合物的有效成分;
方法二:将上述原料药水提发酵,得所述中药组合物的有效成分。
本发明中药组合物所含的有效成分的制备步骤中,
水提条件为:加所述原料药总重量的6-12倍水,煎煮1-3小时后浸泡24-72小时;
水提发酵条件为:加所述原料药总重量的6-12倍水,煎煮1-3小时后浸泡24-72小时得煎煮液A;煎煮液A冷却至30-50℃,加入酒曲密封1-3周得发酵液B;发酵液B中加入酵母将罐密封1-2月。
现有技术中大都采用工业乙醇或白酒浸泡对外用生发中药组合物进行醇提,以促进中药原料药药材有效成分的溶解,提高提取率。本发明不使用工业乙醇提取、不使用白酒浸泡,如方法二是利用水提发酵技术,本发明的制备工艺降低工业化成本,安全无毒,也可适用于家庭使用。
在一个具体的实施方案中,本发明中药组合物的制备方法,还可以加入盐、醋精、食用香精中的一种或几种,优选的,醋精为1%食用大米酿制醋精。
在一个具体的实施方案中,本发明中药组合物的制备方法一:取重量份原料药,烘焙后置于提取罐中,加所述原料药总重量的10倍量水,煎煮1小时后浸泡24小时,得有效成分。
在一个具体的实施方案中,本发明中药组合物的制备方法二:取重量份原料药,烘焙后置于提取罐中,加所述原料药总重量10倍量水,煎煮1小时后浸泡24小时得煎煮液A;煎煮液A冷却至30-50℃,加入适量酒曲后将罐密封2周得发酵液B;发酵液B中加入酵母将罐密封1-2月后得发酵液C;发酵液C中加入微量盐、1%食用大米酿制醋精、食用香精,过滤,得有效成分。
制得的有效成分可以直接入药使用或加入可药用辅料或化妆品基质按制备成所需制剂或化妆品。
本发明的中药组合物的有效成分可以筛选辅料制成各种外用制剂,比如搽剂、凝胶剂、透皮贴剂、散剂、洗剂、气雾剂、喷雾剂等,也可制备纳米乳剂、微乳凝胶剂、贴剂、脂质体凝胶剂、泡沫制剂等新型生发外用制剂,能达到透皮效果好,作用时间长等优异效果。
本发明的中药组合物的有效成分也可以制成各种化妆品,比如护发素、头发喷雾、洗发水、精华素、生发液。
在一个具体的实施方案中,本发明中药组合物的有效成分制成的生发液可以这样制备:将有效成分装瓶后,即得生发液。
在一个具体的实施方案中,本发明中药组合物的有效成分制成的精华素可以这样制备:将有效成分中加入甘油、二肽二氨基丁酰苄基酰胺二乙酸盐、葡萄籽油、抗氧化剂,余量为水,混合后加热至60-80℃,搅拌均匀后,得精华素。
在一个具体的实施方案中,本发明中药组合物的有效成分制成的凝胶剂可以这样制备:将卡波姆加入水溶胀完全,用氢氧化钠调pH值至5-7;将有效成分与丙二醇、适量水混合后,搅拌均匀,加入氮酮,再次搅拌均匀,得凝胶剂。
在一个具体的实施方案中,本发明中药组合物的有效成分制成的微乳凝胶剂可以这样制备:将乙醇、亚油酸甘油酯、微乳浓缩液混匀后加入有效成分,充分溶解得均匀透明的微乳液;称取凝胶基质,加入水中,搅拌后静置,溶胀混匀后,将微乳液缓慢加入其中,再加入氮酮,搅拌均匀,调pH值为6-8,得微乳凝胶剂。
在一个具体的实施方案中,本发明中药组合物的有效成分制成的贴剂可以这样制备:将有效成分加热浓缩后加入硅酮压敏胶,混匀后,涂布于防粘材料上,65-85℃干燥,与背衬材料复合,冲切,得贴剂。
在一个具体的实施方案中,本发明中药组合物的有效成分制成的纳米乳剂可以这样制备:将有效成分、豆磷脂、油酸与精制大豆油混匀,加热至65-80℃,至澄明,得到油溶液,将泊洛沙姆、丙二醇分散至注射用水中,搅拌同时加入有效成分的油溶液得油-水相分散体系中,制成粗乳剂,加水,将粗乳剂在压力100-150Mpa的条件下,通过乳匀机乳化,乳化结束后可于110-120℃,灭菌,分装,得纳米乳剂。
上述制备方法仅对本发明所提制法进行列举,但不应将此理解为本发明制备方法仅仅限于上述所列举方法。
本发明的第三个目的,是提供上述中药组合物用于制备生发育发药物中的应用。
本发明中,如无特别说明,其中:
术语“水提”是指原料药水煎煮后取汁的过程。
术语“水提发酵”是指原料药经水提后的煎煮液(包含药渣)经过酒曲和酵母发酵后,某些药物成分在煎煮液中溶解度增大,而达到煎煮液中提取物含量提高的过程。
术语“有效成分”,是指原料药经提取或发酵之后起治疗作用的提取物的溶液。
与现有技术相比,本发明具有以下有益效果:
1、本发明结合现代中药药理研究,以补中益气、活血生发为主,采用本发明的中药组合物生发育发,标本兼治,处方运用灵活且费用低廉。
2、本发明中药组合物的制备中未使用工业产品,安全无毒,可适用于家庭使用。
3、采用本发明的中药组合物制成外用制剂或化妆品,疗效显著,不复发,使用便利,刺激性小。
附图说明
图1为本发明中药组合物对个体试验例中的病例1使用前和使用后的效果对比图;其中,1.1显示了使用前的头顶部位头发生长状况,1.2显示了使用三个月后的头顶部位的头发生长状况。
图2为本发明中药组合物对个体试验例中的病例2使用前和使用后的效果对比图:其中,2.1显示了使用前的斑秃部位头发生长状况,2.2显示了使用三个月后的原斑秃部位头发生长状况。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述,但本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应视为限定本发明的范围。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规产品。
实施例1-8本发明中药组合物的制备
实施例1
取干生姜5g,何首乌5g,侧柏叶1g,黑豆1g,透骨草1g,当归1g,红花1g,丹参1g,天麻1g,人参1g,土茯苓1g,陈皮1g,烘焙后置于提取罐中,加200ml水,煎煮1小时后浸泡48小时得110ml煎煮液A;煎煮液A冷却至50℃,加入适量酒曲后将罐密封2周得105ml发酵液B;发酵液B中加入酵母将罐密封2个月后得98ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得85ml有效成分。装瓶后,得生发液。
实施例2
取干生姜8g,何首乌6g,侧柏叶3g,黑豆3g,透骨草3g,当归2g,红花2g,丹参2g,天麻2g,人参2g,土茯苓2g,陈皮1g,烘焙后置于提取罐中,加340ml水,煎煮2小时后浸泡48小时得185ml煎煮液A;煎煮液A冷却至40℃,加入适量酒曲后将罐密封3周得180ml发酵液B;发酵液B中加入酵母将罐密封1月后得175ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得160ml有效成分。装瓶后,得生发液。
实施例3
取干生姜13g,制何首乌9g,侧柏叶3g,黑豆3g,透骨草3g,当归2g,红花2g,丹参2g,天麻2g,红参2g,土茯苓2g,陈皮1g,烘焙后置于提取罐中,加440ml水,煎煮1小时后浸泡48小时得225ml煎煮液A;煎煮液A冷却至40℃,加入适量酒曲后将罐密封2周得218ml发酵液B;发酵液B中加入酵母将罐密封2月后得210ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得198ml有效成分;将80g卡波姆加入适量水溶胀完全后,用微量氢氧化钠调节pH值至6,将有效成分与600g丙二醇、1000ml水混合后,搅拌均匀,加入50g氮酮,再次搅拌均匀,得凝胶剂。
实施例4
取干生姜10g,何首乌8g,侧柏叶5g,黑豆5g,透骨草5g,当归3g,红花3g,丹参3g,天麻2g,人参2g,土茯苓2g,陈皮1g,烘焙后置于提取罐中,加560ml水,煎煮1小时后浸泡24小时得335ml煎煮液A;煎煮液A冷却至40℃,加入适量酒曲后将罐密封2周得330ml发酵液B;发酵液B中加入酵母将罐密封1.5月后得325ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得295ml有效成分。装瓶后,得生发液。
实施例5
取干生姜16g,何首乌10g,侧柏叶5g,黑豆5g,透骨草5g,当归4g,红花4g,丹参4g,天麻4g,人参3g,土茯苓2g,陈皮2g,烘焙后置于提取罐中,加760ml水,煎煮2小时后浸泡72小时得480ml煎煮液A;煎煮液A冷却至30℃,加入适量酒曲后将罐密封2周得470ml发酵液B;发酵液B中加入酵母将罐密封1.5月后得465ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得425ml有效成分。将有效成分加热至100℃,浓缩1小时后加入200g硅酮压敏胶,混匀后,涂布于防粘材料上,65-85℃干燥,与背衬材料复合,冲切,得贴剂。
实施例6
取干生姜15g,何首乌10g,侧柏叶8g,黑豆5g,透骨草5g,当归4g,红花4g,丹参4g,天麻3g,人参3g,土茯苓3g,陈皮2g,烘焙后置于提取罐中,加570ml水,煎煮1小时后浸泡72小时得340ml煎煮液A;煎煮液A冷却至40℃,加入适量酒曲后将罐密封3周得334ml发酵液B;发酵液B中加入酵母将罐密封1月后得330ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得310ml有效成分。将20g乙醇、18g亚油酸甘油酯混匀后加入上述有效成分,充分溶解得均匀透明的微乳液;称取5g凝胶基质,加入水中,搅拌后静置,溶胀混匀后,将微乳液缓慢加入其中,再加入2g氮酮,搅拌均匀,调pH值为7,得微乳凝胶剂。
实施例7
取干生姜16g,何首乌12g,侧柏叶8g,黑豆8g,透骨草8g,当归4g,红花3g,丹参3g,天麻2g,人参2g,土茯苓1g,陈皮1g,烘焙后置于提取罐中,加680ml水,煎煮1小时后浸泡72小时得390ml煎煮液A;煎煮液A冷却至40℃,加入适量酒曲后将罐密封3周得374ml发酵液B;发酵液B中加入酵母将罐密封1月后得372ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得355ml有效成分。将有效成分中加入20g甘油、20g二肽二氨基丁酰苄基酰胺二乙酸盐、26g葡萄籽油,3g抗氧化剂,补充余量至400ml,混合后加热至80℃,搅拌均匀后,得精华素。
实施例8
取干生姜20g,何首乌15g,侧柏叶10g,黑豆10g,透骨草10g,当归6g,红花6g,丹参6g,天麻4g,人参4g,土茯苓4g,陈皮2g,烘焙后置于提取罐中,加970ml水,煎煮2小时后浸泡48小时得640ml煎煮液A;煎煮液A冷却至40℃,加入适量酒曲后将罐密封3周得635ml发酵液B;发酵液B中加入酵母将罐密封2月后得625ml发酵液C;发酵液C中加入盐、1%食用大米酿制醋精、食用香精,过滤,得595ml有效成分。装瓶后,得生发液。
以下通过测试试验例来进一步阐述本发明中药组合物在生发育发方面的有益效果。
群体试验例:
1、试验药物及对象
本发明:实施例3制得的凝胶剂
对比药物1:章光101育发剂(北京章光101科技股份有限公司,批准文号:G20140397)
对比药物2:非那雄胺片(保法止,杭州默沙东制药有限公司,国药准字:J20150142)
试验记录病例164名25-65岁年龄段的斑秃、全秃、秃顶患者,其中男84人、女80人,分为三组,生发液组68人,其中男28人,女40人;101对照组68人,其中男28人,女40人;非那雄胺组28人,全部为男性(非那雄胺片仅适用于治疗男性秃发)。
2、试验方法
本发明组:每位患者洗净并擦干头发,然后将实施例3制得的凝胶剂10mL涂抹到头皮上,按揉3-5分钟,每天一次,使用至六个月(秃顶使用三个月时就可以使头发生长出来,而使用六个月使头发固定)。
101对照组:每位患者洗净并擦干头发,然后将对比药物1章光101育发剂10mL涂抹到头皮上,按揉3-5分钟,每日两次,使用至六个月。
非那雄胺组:每位男性患者每天一次,一次一片(1mg),口服对比药物2六个月。
3、疗效评价标准
1)显效:停止脱发,无发区域重新长出头发;
2)有效:停止脱发,部分无发区域重新长出绒毛;
3)无效:脱发无改善,无发处没长出新头发。
4、治疗结果
治疗三个月后总体治疗情况如下:
组 | 治疗病例 | 显效 | 有效 | 无效 | 总有效率 |
本发明组 | 68 | 21 | 36 | 11 | 83.8% |
101对照组 | 68 | 21 | 24 | 23 | 66.2% |
非那雄胺组 | 28 | 0 | 7 | 21 | 25.0% |
治疗六个月后总体治疗情况如下:
组 | 治疗病例 | 显效 | 有效 | 无效 | 总有效率 |
本发明组 | 68 | 41 | 23 | 4 | 94.1% |
101对照组 | 68 | 26 | 26 | 16 | 76.5% |
非那雄胺组 | 28 | 12 | 7 | 9 | 67.8% |
六个月治疗期结束后,再过六个月回访情况如下:
组 | 治疗病例 | 显效 | 有效 | 无效 | 总有效率 |
本发明组 | 68 | 40 | 20 | 8 | 88.2% |
101对照组 | 68 | 12 | 19 | 37 | 45.6% |
非那雄胺组 | 28 | 0 | 5 | 23 | 17.9% |
结果表明,本发明中药组合物制备的凝胶剂用于生发育发,与传统外用中药育发剂、西药相比,具有见效快、疗程短、治愈率高、复发率低优势,值得临床推广和应用。
个体试验例:
病例1:孙某,男,58岁,油性发质,脱发已有八年,头顶头发稀疏,并往外蔓延扩展,自述曾就诊,并诊断为脂溢性脱发,口服某中成药后未见效。后曾使用章光101产品,仍未见效。患者于2018年2月使用本发明实施例4制得的生发液每日一次,一个月后头顶部位长出绒毛,后继续使用至三个月,长出头发并且密度明显增厚,后回访无复发。使用前后的对比图如图1所示。
病例2:胡某,女,61岁,斑秃,伴有大量脱发,发病已有两年,患者自诉既往无类似脱发症状,体健。患者于2018年5月使用本发明实施例4制得的生发液每日一次,一周后脱发问题已改善,不再脱发,一个月后,斑秃位置长出些许短发,使用三个月后,原秃顶部位已治愈,脱发问题已完全改善,后回访无复发。使用前后对比图如图2所示。
病例3:马某,男,28岁,头发稀疏,掉发严重。患者自述常饮酒无量,膳食多荤少素,因工作压力大,睡眠质量差,经常熬夜至凌晨。患者于2018年2月使用本发明实施例2制得的生发液一个月后,发质和掉发量明显改善,头发密度已正常,后回访无复发。
以上所述,仅为本发明的具体实施方式,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,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (10)
1.一种生发育发的中药组合物,其特征在于,所述中药组合物包含以下重量份的原料药:生姜5-20份,何首乌5-15份,侧柏叶1-10份,黑豆1-10份,透骨草1-10份,当归1-6份,红花1-6份,丹参1-6份,天麻1-6份,人参1-6份,土茯苓1-6份,陈皮1-4份。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物包含以下重量份的原料药:生姜8-16份,何首乌6-12份,侧柏叶3-8份,黑豆3-8份,透骨草3-8份,当归2-4份,红花2-4份,丹参2-4份,天麻2-4份,人参2-4份,土茯苓2-4份,陈皮1-3份;
优选地,所述中药组合物包含以下重量份的原料药:生姜13份,何首乌9份,侧柏叶3份,黑豆3份,透骨草3份,当归2份,红花2份,丹参2份,天麻2份,人参2份,土茯苓2份,陈皮1份;
优选地,所述中药组合物包含以下重量份的原料药:生姜10份,何首乌8份,侧柏叶5份,黑豆5份,透骨草5份,当归3份,红花3份,丹参3份,天麻2份,人参2份,土茯苓2份,陈皮1份;
优选地,所述中药组合物包含以下重量份的原料药:生姜15份,何首乌10份,侧柏叶8份,黑豆5份,透骨草5份,当归4份,红花4份,丹参4份,天麻3份,人参3份,土茯苓3份,陈皮2份。
3.根据权利要求1所述的中药组合物,其特征在于如下1)至5)中的一项或多项:
1)所述生姜为干生姜;
2)所述何首乌为制何首乌;
3)所述红花为炒红花或红花炭或醋红花;
4)所述人参为红参或园参或野山参或生晒参或糖参;
5)所述当归为酒当归。
4.根据权利要求1所述的中药组合物,其特征在于,还包含可药用辅料或化妆品基质。
5.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物可制成外用制剂或化妆品,优选的,所述制剂或化妆品为搽剂、纳米乳剂、凝胶剂、透皮贴剂、散剂、洗剂、气雾剂、喷雾剂、微乳凝胶剂、贴剂、脂质体凝胶剂、泡沫制剂、护发素、头发喷雾、洗发水、精华素、生发液中的一种。
6.一种制备权利要求1所述中药组合物的方法,其特征在于,将所述原料药干燥研成粉末,混匀,得到有效成分;或将所述原料药水提,得所述中药组合物的有效成分;或将所述原料药水提发酵,得所述中药组合物的有效成分。
7.根据权利要求6所述的制备方法,其特征在于:
水提条件为:加所述原料药总重量的6-12倍水,煎煮1-3小时后浸泡24-72小时;
水提发酵条件为:加所述原料药总重量的6-12倍水,煎煮1-3小时后浸泡24-72小时得煎煮液A;煎煮液A冷却至30-50℃,加入酒曲后密封1-3周得发酵液B;发酵液B中加入酵母后密封1-2月。
8.根据权利要求6所述的制备方法,其特征在于,还可以加入盐、醋精、食用香精中的一种或几种,优选的,醋精为1%食用大米酿制醋精。
9.根据权利要求6所述的制备方法,其特征在于,如下1)或2):
1)取所述重量份原料药,烘焙后置于提取罐中,加所述原料药总重量的10倍量水,煎煮1小时后浸泡24小时,得有效成分;
2)取所述重量份原料药,烘焙后置于提取罐中,加所述原料药总重量10倍量水,煎煮1小时后浸泡24小时得煎煮液A;煎煮液A冷却至30-50℃,加入适量酒曲后将罐密封2周得发酵液B;发酵液B中加入酵母将罐密封1-2月后得发酵液C;发酵液C中加入微量盐、1%食用大米酿制醋精、食用香精,过滤,得有效成分。
10.根据权利要求1-5任一所述中药组合物在制备生发育发药物中的应用。
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