CN108379544A - 一种治疗痤疮的药物及其制备方法 - Google Patents
一种治疗痤疮的药物及其制备方法 Download PDFInfo
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- CN108379544A CN108379544A CN201810509420.0A CN201810509420A CN108379544A CN 108379544 A CN108379544 A CN 108379544A CN 201810509420 A CN201810509420 A CN 201810509420A CN 108379544 A CN108379544 A CN 108379544A
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Abstract
本发明公开了一种治疗痤疮的药物组合物及其制备方法，属于中医药技术领域。本发明提供的治疗痤疮的药物采用银耳母种以中药原料药混合物的中药水提取液为培养基的发酵产物，所述中药原料药混合物的重量份组份为：苍耳子：30‑50份，白茅根：10‑30份，生川乌：10‑30份，草决明；5‑15份，白蒺藜：5‑15份，胆南星：5‑15份，车前子：10‑30份，蝉蜕：30‑50份，白术：10‑30份，干姜：5‑15份，生地榆：5‑15份，地肤子：10‑30份。本发明提供的治疗痤疮的药物疗效好，见效快，无副作用。
Description
技术领域
本发明涉及中医药技术领域，尤其涉及一种治疗痤疮的药物组合物。
背景技术
痤疮是一种多因素的疾病，常见于头部、面部、胸部、后背，其发病主要与性激素水平、皮脂腺大量分泌、痤疮丙酸杆菌增殖，毛囊皮脂腺导管的角化异常及炎症等因素相关。多种因素常为：①雄激素及其代谢产物增多,使皮脂腺活性增强；②毛囊漏斗部角化过程增强,其细胞膜致密增厚不易脱落；③皮脂腺中游离脂肪酸升高；④毛囊内寄生痤疮丙酸菌；⑤遗传因素；⑥体内微量元素特别是锌的缺乏。西医多采用口服糖皮质激素、异维A酸，抗生素，以及外用维A酸类等，用来治疗痤疮。常常带来多种副作用，如造成皮肤刺激症状，出现表皮剥落、红斑、灼痛感，同时造成皮肤黏膜、眼睛、胃肠道、神经系统、精神心理的不良反应。
中医认为，痤疮由热毒，淤血所致，《外科正宗》说:“粉刺属肺,齇鼻属脾,总皆血热郁滞不散所致”，其病因为肺经郁热,或饮食不节,过食肥甘厚味,胃热上蒸,或月经不调瘀滞化热等。需要通过清热解毒治疗。中成药虽然副作用小，但是见效慢，目前尚未发现对痤疮具有明显治疗效果的中药。
因此，开发对痤疮具有疗效好、见效快、副作用小的药物是目前亟待解决的问题。
发明内容
针对现有技术中尚未发现具有疗效好、见效快、副作用小的中药物的缺陷，本发明提供一种治疗痤疮的药物组合物及其制备方法。
为此，本发明提供如下技术方案：
一种用于治疗痤疮的药物组合物，银耳母种以中药原料药混合物的中药水提取液为培养基的发酵产物，其中，所述中药原料药混合物的重量份组份为：苍耳子：30-50份，白茅根：10-30份，生川乌：10-30份，草决明；5-15份，白蒺藜：5-15份，胆南星：5-15份，车前子：10-30份，蝉蜕：30-50份，白术：10-30份，干姜：5-15份，生地榆：5-15份，地肤子：10-30份。
所述中药原料药混合物的重量份组份选自如下任一：
苍耳子：30份，白茅根：30份，生川乌：10份，草决明；5份，白蒺藜：5份，胆南星：8份，车前子：10份，蝉蜕：33份，白术：17份，干姜：5份，生地榆：5份，地肤子：23份；
苍耳子：33份，白茅根：17份，生川乌：15份，草决明；7份，白蒺藜：8份，胆南星：15份，车前子：15份，蝉蜕：50份，白术：10份，干姜：7份，生地榆：7份，地肤子：10份；
苍耳子：41份，白茅根：10份，生川乌：23份，草决明；17份，白蒺藜：11份，胆南星：5份，车前子：22份，蝉蜕：39份，白术：30份，干姜：10份，生地榆：10份，地肤子：30份；
苍耳子：50份，白茅根：23份，生川乌：30份，草决明；15份，白蒺藜：15份，胆南星：11份，车前子：30份，蝉蜕：30份，白术：21份，干姜：15份，生地榆：15份，地肤子：17份。
所述银耳母种指银耳菌丝母种液，所述银耳菌丝母种液与中药水提取液的体积比例为8～15：100-155。
所述银耳菌丝母种液是由银耳试管母种以含有辅料的中药水提取液作为培养基制备而得，所述辅料的重量份组分为：磷酸氢二钾5-10份、碳酸二氢钾5-15份、硫酸镁2-5份、蜂蜜10-15份、蔗糖50-80份、酵母浸膏20-80份、玉米粉琼脂培养基100-150份。
所述辅料的重量份组分为：磷酸氢二钾8份、碳酸二氢钾7份、硫酸镁4份、蜂蜜12份、蔗糖70份、酵母浸膏50份、玉米粉琼脂培养基120份。
以所述的药物组合物为有效成分的药剂。
上述用于治疗痤疮的药物组合物的制备方法，其特征在于：将银耳母种接种到所述中药水提取液中发酵。
所述发酵的步骤为：
(1)制备中药水提取液：将中药原料药的混合物切碎后与纯净水混合置于超声提取机中萃取后过滤得到中药水提取液，萃取温度40-50℃，萃取时间为30-60min，萃取功率为260W，所述中药原料药的混合物与纯净水的重量份配比为：1：8-15；
(2)接种：对所述中药水提取液进行常压灭活，待冷却至常温，接种银耳母种；
(3)深层发酵：发酵时间为72～144小时，发酵温度为20℃-27℃。
所述步骤(1)所述萃取温度为45℃，萃取时间为45min，所述中药原料药的混合物与纯净水的重量份配比为1:10。
在步骤(3)所述深层发酵后，还需要对发酵产物进行放罐、浓缩、焙干、过筛最后得粉状制品。
苍耳子：英文名XANTHII FRUCTUS，菊科植物苍耳Xanthium sibiricum Patr.的带总苞的果实。性味与归经：味苦；甘；辛；性温；小毒。化学成分：果实含苍耳子甙1.2％、树脂3.3％，以及脂肪油、生物碱、维生素C和色素等。干燥果实含脂肪油9.2％，其脂肪酸中亚油酸占64.20％、油酸26.8％，棕榈酸5.32％、硬脂酸3.63％。不皂化物中有蜡醇，β-，γ-，和ε-谷甾醇，丙酮不溶脂中卵磷脂占33.2％，脑磷脂占66.8％。种仁含水6～7％，脂肪油40％，其脂肪酸组成为亚油酸64.8％、油酸26.7％、硬脂酸7.0～7.5％、棕榈酸1.5～2.0％，并含β-谷甾醇和豆甾醇。种壳含戊聚糖15.86％。功效为发散风寒，通鼻窍，祛风湿，止痛。
白茅根：英文名IMPERATAE RHIZOMA，禾本科植物白茅Imperata cylindricaBeauv.var.major(Nees)C.E.Hubb.的干燥根茎。性味与归经：味甘，性寒。化学成分：根茎含有三萜成分芦竹素(Arundoin 0.1％)、白茅素(Cylindrin0.001％)、羊齿烯醇(Fernenol)、异乔木萜醇(Isoarborinol)、西米杜鹃醇(simiarenol)、羊齿烯酮(Arborinone)、乔木萜醇(Arborinol)、无羁萜(Friedelin)；叶含乔木萜醇甲醚，黄酮类化合物苜蓿素-5-葡萄糖甙、异荭草素、异荭草素-7-O-葡萄糖甙等。此外，全草含5-羟色胺、木犀草定、薏苡素等。用于凉血止盘，清热利尿。
生川乌：英文名ACONITI RADIX，毛莨科一年生草本植物RadixAconiti的母根。化学成分为总生物碱含量2.3％，酯1.0％，乌头碱0.3％。主要含乌头碱(aconitine)、中乌头碱(mesaconitine)、塔技乌头胺(talatisamine)、杰斯乌头胺(jasaconitine)、苯甲酰乌头胺(benzoylaconine)、苯甲酰中乌头胺(benzoylmesaconine)和苯甲酰下乌头胺(benzoylhypaconine)等。功效为：祛风除湿、温经止痛。
草决明；英文名PLANTAGINIS SEMEN，豆科植物决明或小决明Catsia tora Linn的干燥成熟种子，味苦、甘、咸，性微寒。功效为：润肠通便，降脂明目，治疗便秘及高血脂，高血压。清肝明目，利水通便，有缓泻作用，降血压降血脂。
白蒺藜：英文名FRUCTUS TRIBULI，蒺藜科植物蒺藜Tribulus terrestris L.的果实，味苦、辛，平，有小毒，含刺蒺藜苷、紫云英苷、山柰酚-3-芸香糖苷、山柰酚。种子含哈尔满碱、哈尔明碱，少量挥发油和油酯。可用于平肝解郁，祛风明目。用于肝阳眩晕头痛，肝郁胁痛，风热头痛，目赤肿痛，皮肤瘙痒等症。
胆南星：英文名ARISAEMA CUM BILE，胆南星由天南星的细粉与牛、羊或猪胆汁经加工而成，或为生天南星细粉与牛、羊或猪胆汁经发酵加工而成，呈方块状或圆柱状；棕黄色、灰棕色或棕黑色；质硬；气微腥，味苦。胆南星有清热化痰，胆南星苦凉，苦能燥湿化痰，寒能清热功效，可用治痰火咳嗽，头风眩晕，中风痰壅，老年神困，产后怔忡，痰火失眠等症状。功效有：清火化痰，镇惊定痼，可治中风痰迷，惊风癫痫，痰火喘嗽，头风眩晕。
车前子：英文名PLANTAGINIS SEMEN，车前科植物车前Plantago asiatica L.或平车前Plantagodepressa Willd.的干燥成熟种子，主要成分月桃叶珊瑚甙(aucubin)，车前粘多糖(plantago-mulilage)，消旋-车前子甙(plantago-side)，都桷子甙酸(geniposidicacid)，车前子酸(plantenolic acid)，琥珀酸(succinic acid)，腺嘌呤(adenine)，胆碱(choline)及10.43％的脂肪油，β-谷甾醇(β-sitosterol)、β-谷甾醇-3-O-β-D-吡喃葡萄糖甙(β-sitosteryl-3-O-β-D-glucopyranoside)，功能利水通淋、渗湿止泻、清肝明目、清热化痰。
蝉蜕：英文名CICADAE PERIOSTRACUM，蝉科昆虫黑蚱Cryptotympana pustulataFabricius的若虫羽化时脱落的皮壳；味甘，寒。功能为：疏散风热，利咽，透疹，明目退翳，解痉。
白术：英文名ATRACTΜLODIS MACROCEPHALAE RHIZOMA，拉丁学名Atractylodesmacrocephala。别名桴蓟，于术，冬白术，淅术，杨桴，吴术，片术、苍术等，属于菊科、苍术属多年生草本植物。喜凉爽气候，以根茎入药,根茎含挥发油，主要含有挥发油，挥发油中的主要成分为苍术酮，还分离得甘露聚糖AM-3，有免疫增强作用，另外本品还含α-葎草烯、石竹烯、桉叶醇、双白术内酯、东莨菪素、γ-固醇等。主治：健脾益气，燥湿利水，止汗，安胎。用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安。
干姜：英文名：ZINGIBERIS RHIZOMA，姜科植物姜Zingiber oj-jicinale Rosc.的干燥根茎，味辛，性热。主要成分为姜酮(zingiberone)、β-没药烯(β-bisabolene)、姜醇(zingiberol)、姜烯(zingiberene)及姜辣醇类(gingerols)、6-姜辣烯酮(6-shogaol)，8-姜辣烯酮(8-shogaol)等。功效有：温中散寒，回阳通脉，温肺化饮。
生地榆：英文名：SANGUISORBAE RADIX，蔷薇科植物地榆Sanguisorbaofficinalis L.或长叶地榆Sanguisorba officinalis L.var.longifolia(Bert.)YuetLi的干燥根，根含鞣质和三萜皂甙.分离出的皂甙有地榆糖甙Ⅰ(Ziyu glycosideⅠ)、地榆糖甙Ⅱ(Ziyu glycosideⅡ)，其水解后产生坡模醇酸(Pomolic acid)和阿拉伯糖等.另含有地榆甙A、B及E(Sanguisorbin A、B及E),其甙元均为熊果酸(Ursolic acid).叶含维生素C,花含矢车菊甙(Chrysanthemin)、矢车菊双甙(Cyanin)。主治凉血止血，清热解毒，消肿敛疮主治吐血，咯血，衄血，尿血，便血，痔血，血痢，崩漏，赤白带下，疮痈肿痛，湿疹，阴痒，水火烫伤，蛇虫咬伤。
地肤子：英文名KOCHIAE FRUCTUS，藜科植物地肤Kochia scoparia(L.)Schrad.的干燥成熟果实。主含三萜及其甙。功效为清热利湿，祛风止痒。
蜂蜜：含微量维生素，其中有维生素A、维生素B1、维生素B2、维生素B6、维生素C、维生素D、维生素K、尼克酸、泛酸、叶酸、生物素、胆碱等。在含氮化合物中有蛋白质、胨、氨基酸等。尚含转化酶、过氧化氢酶、淀粉酶、氧化酶、还原酶等酶类，并含乙酰胆碱。灰分中主要含镁、钙、钾、钠、硫、磷以及微量元素铁、铜、锰、镍等。有机酸中含有柠檬酸、苹果酸、琥珀酸、甲酸、乙酸等。蜂蜜中含葡萄糖和果糖，蔗糖糊精和非糖物质、矿物质、有机酸等含量在5％左右。此外，还含有少量的酵素、芳香物质和维生素等。可以润肠通便，润肺止咳解毒、医疮、止痛。有消炎、止痛、止血、减轻水肿、促进伤口愈合的作用；可众中益气、调和诸药，提高药性。蜂蜜性平，味甘(甜)，常作引药用。
银耳：银耳味甘、淡、性平、无毒，既有补脾开胃的功效，又有益气清肠、滋阴润肺的作用。既能增强人体免疫力，又可增强肿瘤患者对放、化疗的耐受力。银耳富有天然植物性胶质，外加其具有滋阴的作用，是可以长期服用的良好润肤食品。银耳具有强精、补肾、润肠、益胃、补气、和血、强心、壮身、补脑、提神、美容、嫩肤、延年益寿之功效。它能提高肝脏解毒能力，保护肝脏功能，它不但能增强机体抗肿瘤的免疫能力，还能增强肿瘤患者对放疗、化疗的耐受力。可以滋补生津；润肺养胃，补肺益气。虚劳咳嗽；痰中带血；津少口渴；病后体虚；气短乏力，银耳也是一味滋补良药，特点是滋润而不腻滞，具有补脾开胃、益气清肠、安眠健胃、补脑、养阴清热、润燥之功，银耳富有天然特性胶质，加上它的滋阴作用，长期服用可以润肤，并有祛除脸部黄褐斑、雀斑的功效。银耳是种含膳食纤维的减肥食品，它的膳食纤维可助胃肠蠕动，减少脂肪吸收。
与现有技术相比，本发明提供的药物组合物具有如下有益效果：
1、本发明提供的治疗痤疮的药物组合物具有疗效好，见效快，无副作用，对多种痤疮症型都具有很好疗效，对痤疮顽疾患者效果甚佳，可以治愈多症型患者以及长期顽疾患者。
2、本发明提供的治疗痤疮的药物组合物用银耳母种以中药原料药混合物的水提取液为液体培养基进行共菌发酵的产物，其主要是通过提取中药原料药的水提取液，然后在中药水提取液中接种银耳菌丝母种液，进行深层发酵，其中中药中的多糖以及银耳中的多种多糖物质在第一次发酵和深层发酵中发生两次缀合过程，使本发明的药物中含有更高含量，更多种类的多糖缀合物，能够促进肝脏蛋白质合成的主要环节如促进转录过程，增加、促进RNA合成，有效提高肝脏解毒能力，进而调节体内激素平衡，同时促进T淋巴细胞的增殖,增强人体免疫能力，从痤疮的发病源头进行治疗。
3、本发明提供的治疗痤疮的药物组合物所用的银耳母种液中还加入了蜂蜜，深层发酵使中药原料药中的植物多糖，动物多糖，银耳多糖以及蜂蜜中糖分子有机会发生缀合形成更复杂的大分子杂多糖，服用本品后，人体将受到植物多糖，银耳多糖，动物源多糖以及它们的缀合物四类大分子物质的主动刺激，改善身体机能，促进新陈代谢，对于痤疮患者治标又固本。
4、本发明提供的治疗痤疮的药物组合物将银耳保护、修复脏腑脾肺以及活血养血方面的效果，结合苍耳子、白茅根，车前子和地肤子祛风除湿、凉血、解热，清肝等方面的功效，以及其他中药原料药的功效，共同发酵，各有效成分在发酵过程中相互间产生了协同作用，增强治疗痤疮的作用效果，并且各有效成分的效果相互得到增强。
5、本发明提供的治疗痤疮的药物组合物通过清热散毒，顺通脉络，调节脏腑，凉血清火达到增强免疫力，恢复活力，全面调节机体代谢状态的效果；该药物对饮食不节，复感外邪，使毛囊闭塞，内热不通，以及肺经蕴热，外感风邪，或脾胃湿热导致的痤疮有显著效果，并且无任何毒副作用。
6.本发明提供的制备方法制备得到的治疗痤疮的药物组合物配方天然，疗效显著，不易产生耐受性，可实现工业规模生产。
具体实施方式
提供下述实施例是为了更好地进一步理解本发明，并不局限于所述最佳实施方式，不对本发明的内容和保护范围构成限制，任何人在本发明的启示下或是将本发明与其他现有技术的特征进行组合而得出的任何与本发明相同或相近似的产品，均落在本发明的保护范围之内。
实施例中未注明具体实验步骤或条件者，按照本领域内的文献所描述的常规实验步骤的操作或条件即可进行。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试剂产品。
一、材料：
银耳试管母种ACCC 50546：商购中国农业微生物菌种保藏管理中心(ACCC)，保藏编号为：ACCC 50546。
试管斜面种(试管规格18mm×180mm，约40毫升)。购买到的或现有技术中记载的其它银耳试管母种也适用本发明。申请人实验室亦有亦有保存，并制备成试管菌丝母种，自申请日起二十年可向公众发放用于实验研究。
中药原料药在一般中药房可购买到。
二、设备：
超高压锅：DEPCOA-500,采用超高压灭菌技术(Ultra-highpressureprocessing),简称UHP；高压食品加工技术(highpressure processing)。发酵罐：为专利号03270560.3，名称为“食用菌液体菌种培养罐的罐盖及培养罐”的实用新型专利中记载的发酵罐。
注射器：专利号200320126960.X，名称为“食用菌液体注射杆及包含该注射杆的注射器”的实用新型专利中记载的注射器。
实施例1.
步骤1、制备中药水提取液
中药原料药及其重量份为：苍耳子：30份，白茅根：30份，生川乌：10份，草决明；5份，白蒺藜：5份，胆南星：8份，车前子：10份，蝉蜕：33份，白术：17份，干姜：5份，生地榆：5份，地肤子：23份。
取上述中药原料药的混合物切碎后与纯净水混合置于超声提取机中萃取后过滤得到中药水提取液，萃取温度40℃，萃取时间为45min，萃取功率为260W，所述中药原料药的混合物与纯净水的重量分配比为：1：8；
步骤2、准备银耳菌丝母种液：
1)取15kg步骤1所得的中药水提取液，然后加入磷酸氢二钾50g、碳酸二氢钾150g、硫酸镁20g、蜂蜜120g、蔗糖500g、酵母浸膏800g、玉米粉琼脂培养基1000g，再添加步骤1的中药水提取液制备成25kg的混浊液。
2)将12.5kg的混浊液注入500ml玻璃瓶内，每瓶400ml，共制12瓶，置入手提高压锅内在0.012MP/cm2，30min，取出后冷却至28℃～34℃，放入超净工作台内。
3)将工具、器皿以及液体培养基放入超净工作台内，用30g高锰酸钾置入盛有50％福尔马林30ml的器皿中，接种用的勾、耙、针、刀放入该器皿中灭菌30min。
4)将试管内银耳母种，切成3份，每份分别接入400ml/瓶的混浊液内，静置120min-150min。
5)在摇床上以20次/min，振荡72-96小时，镜检无杂菌，即得银耳菌丝母种液。
步骤3、深层发酵
将步骤1获得的中药水提取液置于题为《食用菌液体菌种培养罐的罐盖及培养罐》专利号为ZL03270560.3的发酵罐中作为发酵底物。并将发酵罐推入《饱和蒸气无压锅炉》专利号为ZL200320126611.8的的锅炉中常压水蒸汽灭活12小时。待罐内底物冷却至28～34℃时，用名称为“食用菌液体注射杆及包含该注射杆的注射器”专利号为ZL200320126960.X的接种注射器，将步骤2制备得到的银耳菌丝母种液注入到中药水提取液中；接种量为：银耳菌丝母种液与中药水提取液的体积比例为8：155，在22～28℃(银耳生长适宜温度为：20℃～30℃)环境下深层发酵72小时，放罐。
步骤4.制取药物：
放罐后得到的深层发酵产物，进行浓缩，焙干，过筛得粉状制品8kg，部分保留粉剂状态，制成胶囊，每粒含0.35g粉剂。
实施例2.
步骤1、制备中药水提取液
中药原料药及其重量份为：苍耳子：33份，白茅根：17份，生川乌：15份，草决明；7份，白蒺藜：8份，胆南星：15份，车前子：15份，蝉蜕：50份，白术：10份，干姜：7份，生地榆：7份，地肤子：10份。
取上述中药原料药的混合物切碎后与纯净水混合置于超声提取机中萃取后过滤得到中药水提取液，萃取温度40℃，萃取时间为45min，萃取功率为260W，所述中药原料药的混合物与纯净水的重量分配比为：1：10；
步骤2、准备银耳菌丝母种液：
1)取15kg步骤1所得的中药水提取液，然后加入磷酸氢二钾80g、碳酸二氢钾70g、硫酸镁40g、蜂蜜120g、蔗糖700g、酵母浸膏500g、玉米粉琼脂培养基1200g，再添加步骤1的中药水提取液制备成25kg的混浊液。
2)将12.5kg的混浊液注入500ml玻璃瓶内，每瓶400ml，共制12瓶，置入手提高压锅内在0.012MP/cm2，30min，取出后冷却至28℃～34℃，放入超净工作台内。
3)将工具、器皿以及液体培养基放入超净工作台内，用30g高锰酸钾置入盛有50％福尔马林30ml的器皿中，接种用的勾、耙、针、刀放入该器皿中灭菌30min。
4)将试管内银耳母种，切成3份，每份分别接入400ml/瓶的混浊液内，静置120min-150min。
5)在摇床上以20次/min，振荡72-96小时，镜检无杂菌，即得银耳菌丝母种液。
步骤3、深层发酵
将步骤1获得的中药水提取液置于题为《食用菌液体菌种培养罐的罐盖及培养罐》专利号为ZL03270560.3的发酵罐中作为发酵底物。并将发酵罐推入《饱和蒸气无压锅炉》专利号为ZL200320126611.8的的锅炉中常压水蒸汽灭活12小时。待罐内底物冷却至28～34℃时，用名称为“食用菌液体注射杆及包含该注射杆的注射器”专利号为ZL200320126960.X的接种注射器，将步骤2制备得到的银耳菌丝母种液注入到中药水提取液中；接种量为：银耳菌丝母种液与中药水提取液的体积比例为15：130，在22～28℃(银耳生长适宜温度为：20℃～30℃)环境下深层发酵100小时，放罐。
步骤4.制取药物：
放罐后得到的深层发酵产物，进行浓缩，焙干，过筛得粉状制品7.5kg，部分保留粉剂状态，制成胶囊，每粒含0.35g粉剂。
实施例3.
步骤1、制备中药水提取液
中药原料药及其重量份为：苍耳子：41份，白茅根：10份，生川乌：23份，草决明；17份，白蒺藜：11份，胆南星：5份，车前子：22份，蝉蜕：39份，白术：30份，干姜：10份，生地榆：10份，地肤子：30份。
取上述中药原料药的混合物切碎后与纯净水混合置于超声提取机中萃取后过滤得到中药水提取液，萃取温度40℃，萃取时间为45min，萃取功率为260W，所述中药原料药的混合物与纯净水的重量分配比为：1：12；
步骤2、准备银耳菌丝母种液：
1)取15kg步骤1所得的中药水提取液，然后加入磷酸氢二钾70g、碳酸二氢钾100g、硫酸镁50g、蜂蜜100g、蔗糖800g、酵母浸膏200g、玉米粉琼脂培养基1500g，再添加步骤1的中药水提取液制备成25kg的混浊液。
2)将12.5kg的混浊液注入500ml玻璃瓶内，每瓶400ml，共制12瓶，置入手提高压锅内在0.012MP/cm2，30min，取出后冷却至28℃～34℃，放入超净工作台内。
3)将工具、器皿以及液体培养基放入超净工作台内，用30g高锰酸钾置入盛有50％福尔马林30ml的器皿中，接种用的勾、耙、针、刀放入该器皿中灭菌30min。
4)将试管内银耳母种，切成3份，每份分别接入400ml/瓶的混浊液内，静置120min-150min。
5)在摇床上以20次/min，振荡72-96小时，镜检无杂菌，即得银耳菌丝母种液。
步骤3、深层发酵
将步骤1获得的中药水提取液置于题为《食用菌液体菌种培养罐的罐盖及培养罐》专利号为ZL03270560.3的发酵罐中作为发酵底物。并将发酵罐推入《饱和蒸气无压锅炉》专利号为ZL200320126611.8的的锅炉中常压水蒸汽灭活12小时。待罐内底物冷却至28～34℃时，用名称为“食用菌液体注射杆及包含该注射杆的注射器”专利号为ZL200320126960.X的接种注射器，将步骤2制备得到的银耳菌丝母种液注入到中药水提取液中；接种量为：银耳菌丝母种液与中药水提取液的体积比例为10：100，在22～28℃(银耳生长适宜温度为：20℃～30℃)环境下深层发酵144小时，放罐。
步骤4.制取药物：
放罐后得到的深层发酵产物，进行浓缩，焙干，过筛得粉状制品8kg，部分保留粉剂状态，制成胶囊，每粒含0.35g粉剂。
实施例4.
步骤1、制备中药水提取液
中药原料药及其重量份为：苍耳子：50份，白茅根：23份，生川乌：30份，草决明；15份，白蒺藜：15份，胆南星：11份，车前子：30份，蝉蜕：30份，白术：21份，干姜：15份，生地榆：15份，地肤子：17份。
取上述中药原料药的混合物切碎后与纯净水混合置于超声提取机中萃取后过滤得到中药水提取液，萃取温度40℃，萃取时间为45min，萃取功率为260W，所述中药原料药的混合物与纯净水的重量分配比为：1：15；
步骤2、准备银耳菌丝母种液：
1)取15kg步骤1所得的中药水提取液，然后加入磷酸氢二钾100g、碳酸二氢钾50g、硫酸镁30g、蜂蜜150g、蔗糖750g、酵母浸膏650g、玉米粉琼脂培养基1300g，再添加步骤1的中药水提取液制备成25kg的混浊液。
2)将12.5kg的混浊液注入500ml玻璃瓶内，每瓶400ml，共制12瓶，置入手提高压锅内在0.012MP/cm2，30min，取出后冷却至28℃～34℃，放入超净工作台内。
3)将工具、器皿以及液体培养基放入超净工作台内，用30g高锰酸钾置入盛有50％福尔马林30ml的器皿中，接种用的勾、耙、针、刀放入该器皿中灭菌30min。
4)将试管内银耳母种，切成3份，每份分别接入400ml/瓶的混浊液内，静置120min-150min。
5)在摇床上以20次/min，振荡72-96小时，镜检无杂菌，即得银耳菌丝母种液。
步骤3、深层发酵
将步骤1获得的中药水提取液置于题为《食用菌液体菌种培养罐的罐盖及培养罐》专利号为ZL03270560.3的发酵罐中作为发酵底物。并将发酵罐推入《饱和蒸气无压锅炉》专利号为ZL200320126611.8的的锅炉中常压水蒸汽灭活12小时。待罐内底物冷却至28～34℃时，用名称为“食用菌液体注射杆及包含该注射杆的注射器”专利号为ZL200320126960.X的接种注射器，将步骤2制备得到的银耳菌丝母种液注入到中药水提取液中；接种量为：银耳菌丝母种液与中药水提取液的体积比例为12：150，在22～28℃(银耳生长适宜温度为：20℃～30℃)环境下深层发酵120小时，放罐。
步骤4.制取药物：
放罐后得到的深层发酵产物，进行浓缩，焙干，过筛得粉状制品8kg，部分保留粉剂状态，制成胶囊，每粒含0.35g粉剂。
对比例1.
采用根据中国专利CN107890534A制备得到用于治疗痤疮的中草药内服药剂作为对照例X1。
对比例2.
采用银耳母种ACCC 50546按照常规方法培养的银耳作为对照例X2。
实验例
1、实验目的
研究本发明的药物组合物治疗痤疮的效果。
2、材料与方法
2.2实验药物
中草药内服药剂(根据专利文献CN107890534A制备)，银耳(采用银耳母种ACCC50546按照常规方法培养的银耳)，实施例1制备得到的产品，实施例2制备得到的产品，实施例3制备得到的产品，实施例4制备得到的产品
2.3分组及给药方法
目前，根据国际上通用的痤疮的三度四级分类法，1、轻度即为Ⅰ级，表现为粉刺为主，少量丘疹和脓疱，总病灶数少于30个。2、中度分为Ⅱ、Ⅲ两级；Ⅱ级表现为有粉刺，中等量的丘疹和脓疱，总病灶数31～50之间；Ⅲ级表现为大量丘疹和脓疱，偶见大的炎性皮损，分布广泛，总病灶数在51～100之间，结节小于3个。3、重度即为Ⅳ级，表现为结节/囊肿性痤疮或聚合性痤疮，多数有疼痛并形成囊肿和窦道，总病灶数在100个以上，结节/囊肿在3个以上。
选择540例痤疮患者分成6组：组1-组4，中草药制剂X1组，银耳X2组，每组90例，并且每组由A、B、C三个小组构成，其分别包括30例轻度痤疮患者，30例中度痤疮患者，30例中度痤疮患者，组1-4、中草药制剂X1组分别服用实施例1-4的制品以及X1 6g/次，一日3次，银耳X2组的患者服用X2制品20g/次，一日3次，服用时间为早、中、晚餐后1小时，连续服用2个月，其余时间不限制饮食，不改变生活方式。观察患者2周、4周、6周、7周、8周的治疗效果。
实验期间，受试者尽量保持膳食和生活习惯不限，不能服用治疗痤疮的其他药物。
3、治疗结果
统计患者者2周、4周、6周、7周、8周观察痊愈效果，统计痊愈情况，痊愈是指轻度患者的粉刺、炎性丘疹消失，无病灶。中度患者粉刺基本消失，无丘疹、脓疱炎性、皮损和结节，总病灶少于3个。重度患者深在性脓包基本消失，无结节、囊肿性痤疮、聚合性痤疮，窦道，无疼痛感，总病灶数少于5个。
表一 轻度痤疮患者治疗效果
从表一可以看出，相比中草药制剂组和银耳组，组1-4见效更快，至第6周已经达到全部治愈，治愈效果更加理想。
表二：中度痤疮患者治疗效果
从表二可以看出，相比中草药制剂组和银耳组，组1-4中的中度痤疮患者疗效较好，并且治疗效果稳定，无反复情况。
表三 中度痤疮患者治疗效果
从表三可以看出，相比中草药制剂组和银耳组，组1-4重度痤疮患者治疗效果显著，治愈人数显著多于对照组。
表四 痤疮患者总体治疗效果
从表四看出，接受本申请的药物治疗后，治愈率达到90％以上，最高达99％，治疗效果显著。
治疗过程中，患者普遍认为，本发明的药物组合物不会对肠胃消化造成干扰，对身体无任何毒副作用，经检测，患者接受治疗后，皮脂腺功能降低，皮脂分泌显著减少，抑制黑头粉刺的形成；血清睾酮水平下降，皮损得以改善；血清中雌二醇水平有效升高，对痤疮丙酸杆菌、葡萄球菌、糠秕孢子菌产生抑制作用，减轻毛囊炎症的发生；抗炎因子脂联素升高，这表明机体消除炎性反应的机能在治疗后恢复。由此可见，本发明的药物可全面的调节身体机能，改善皮脂分泌，调节体内环境，从根本上治疗痤疮。
4、跟踪观察治疗效果
540例患者2个月的治疗过程后，组1-4、中草药制剂X1组和银耳X2组中A、B、C组中1/2的患者停止服药，另外1/2的患者每日晚餐后半小时分别服用实施例1-4的制品以及X13g、X2制品10g，连续服用4周，其余时间不限制饮食，不改变生活方式。观察患者4周后情况。
4周后跟踪观察发现，停止用药后，组1-4中的患者痤疮基本无复发现象、少数中草药制剂X1组患者出现痤疮复发情况，银耳X2组中的患者痤疮整体情况加重。这表明本申请的药物治疗效果稳定，效果持续时间长。
减量服药的组1-4中的患者总体痤疮情况持续好转，另外还观察到已经治愈的患者持续服药后，痤疮留下的疤痕、痘坑、痘印出现明显消退，皮肤情况显著得到改善，中草药制剂组和银耳组的患者情况与治疗阶段第7-8周情况接近，未观察到对痤疮留下的疤痕、痘坑、痘印有修复效果。
5、实验结论
本发明的药物组合物，各原料在特定的配比下相互配合、共同作用，显效快，治愈率高，治疗彻底，不反复，因此具有显著的治疗痤疮的作用。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种用于治疗痤疮的药物组合物，其特征在于，银耳母种以中药原料药混合物的中药水提取液为培养基的发酵产物，其中，所述中药原料药混合物的重量份组份为：苍耳子：30-50份，白茅根：10-30份，生川乌：10-30份，草决明；5-15份，白蒺藜：5-15份，胆南星：5-15份，车前子：10-30份，蝉蜕：30-50份，白术：10-30份，干姜：5-15份，生地榆：5-15份，地肤子：10-30份。
2.根据权利要求1所述的药物组合物，其特征在于，所述中药原料药混合物的重量份组份选自如下任一：
苍耳子：30份，白茅根：30份，生川乌：10份，草决明；5份，白蒺藜：5份，胆南星：8份，车前子：10份，蝉蜕：33份，白术：17份，干姜：5份，生地榆：5份，地肤子：23份；
苍耳子：33份，白茅根：17份，生川乌：15份，草决明；7份，白蒺藜：8份，胆南星：15份，车前子：15份，蝉蜕：50份，白术：10份，干姜：7份，生地榆：7份，地肤子：10份；
苍耳子：41份，白茅根：10份，生川乌：23份，草决明；17份，白蒺藜：11份，胆南星：5份，车前子：22份，蝉蜕：39份，白术：30份，干姜：10份，生地榆：10份，地肤子：30份；
苍耳子：50份，白茅根：23份，生川乌：30份，草决明；15份，白蒺藜：15份，胆南星：11份，车前子：30份，蝉蜕：30份，白术：21份，干姜：15份，生地榆：15份，地肤子：17份。
3.根据权利要求1所述的药物组合物，其特征在于，所述银耳母种指银耳菌丝母种液，所述银耳菌丝母种液与中药水提取液的体积比例为8～15：100-155。
4.根据权利要求1所述的药物组合物，其特征在于，所述银耳菌丝母种液是由银耳试管母种以含有辅料的中药水提取液作为培养基制备而得，
所述辅料的重量份组分为：磷酸氢二钾5-10份、碳酸二氢钾5-15份、硫酸镁2-5份、蜂蜜10-15份、蔗糖50-80份、酵母浸膏20-80份、玉米粉琼脂培养基100-150份。
5.根据权利要求4所述的药物组合物，其特征在于，所述辅料的重量份组分为：磷酸氢二钾8份、碳酸二氢钾7份、硫酸镁4份、蜂蜜12份、蔗糖70份、酵母浸膏50份、玉米粉琼脂培养基120份。
6.以权利要求1～5任一所述的药物组合物为有效成分的药剂。
7.权利要求1～6任一所述的用于治疗痤疮的药物组合物的制备方法，其特征在于：将银耳母种接种到所述中药水提取液中发酵。
8.根据权利要求8所述的方法，其特征在于，所述发酵的步骤为：
(1)制备中药水提取液：将中药原料药的混合物切碎后与纯净水混合置于超声提取机中萃取后过滤得到中药水提取液，萃取温度40-50℃，萃取时间为30-60min，萃取功率为260W，所述中药原料药的混合物与纯净水的重量分配比为：1：8-15；
(2)接种：对所述中药水提取液进行常压灭活，待冷却至常温，接种银耳母种；
(3)深层发酵：发酵时间为72～144小时，发酵温度为20℃-27℃。
9.根据权利要求8所述的方法，其特征在于，所述步骤(1)所述萃取温度为45℃，萃取时间为45min，所述中药原料药的混合物与纯净水的重量分配比为1:10。
10.根据权利要求9所述的方法，其特征在于，在步骤(3)所述深层发酵后，还需要对发酵产物进行放罐、浓缩、焙干、过筛最后得粉状制品。
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