CN106267120A - 一种治疗鼻炎的中药制剂及其制备方法 - Google Patents
一种治疗鼻炎的中药制剂及其制备方法 Download PDFInfo
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- CN106267120A CN106267120A CN201610879344.3A CN201610879344A CN106267120A CN 106267120 A CN106267120 A CN 106267120A CN 201610879344 A CN201610879344 A CN 201610879344A CN 106267120 A CN106267120 A CN 106267120A
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Abstract
本发明涉及中医药领域,尤其涉及一种治疗鼻炎的中药制剂。由川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生等组成。本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明各原料有效成份相互影响、协同作用,对鼻炎有很好的治疗效果。而且本发明中药制备方法简单、配伍严谨、药性平和、安全无副作用、成本低廉,适宜各类人群服用,便于在临床上大面积推广应用。
Description
技术领域
本发明属于中药学技术领域,具体涉及一种治疗鼻炎的中药制剂及其制备方法。
背景技术
鼻炎分为急性鼻炎和慢性鼻炎,慢性鼻炎又包括慢性单纯性鼻炎和慢性肥厚性鼻炎。慢性单纯性鼻炎表现为鼻粘膜充血、肿胀,呈红色或暗红色,以间歇性、交替性鼻塞,鼻涕量多为主要症状;慢性肥厚性鼻炎鼻塞较重,多为持续性,有闭塞性鼻音,嗅觉减退,鼻涕为黏液性或黏脓性,不易擤出,多伴有头痛、头昏、失眠及精神萎靡等症状。以上两种慢性鼻炎一般病程较长,疲劳、感寒后症状加重,易并发耳胀、耳闭等症。急性鼻炎又称伤风鼻塞,以鼻塞、喷嚏、清涕为主要症状,通过鼻腔检查,表现为鼻粘膜充血,鼻腔内分泌物增多,起症较急,病程较短。
当前,治疗鼻炎的药物很多,常用的主要有内服刑和外用型,内服药由于需要经过全身循环送至鼻腔粘膜等原因,能够到达鼻部的药物已经很少,因此具有起效慢、药效小的缺点。外用型对此病虽然有一定的疗效,但是多能治标而不能治本。
发明内容
为了克服现有技术中的不足,本发明提供一种治疗鼻炎的中药制剂,具有显著疗效。
为了解决上述技术问题,本发明采用的技术方案如下:一种治疗鼻炎的中药制剂,由以下各组分组成:
川芎1-20份、麝香1-20份、冰片1-20份、苍耳子1-20份、麻黄1-20份、细辛1-20份、薄荷1-20份、黄柏1-20份、党参1-20份、甘草1-20份、黄芩1-20份、益母草1-20份、金银花1-20份、地榆1-20份、大枣1-20份、徐长卿1-20份、白芷1-20份、辛夷1-20份、瓜蒌1-20份、羌活1-20份、虎杖1-20份、芦荟1-20份、防风1-20份、枸杞1-20份、五味子1-20份、干姜1-20份、黄精1-20份、鹅不食草1-20份、桔梗1-20份、贝母1-20份、沙苑子1-20份、莪术1-20份、没药1-20份、血竭1-20份、乳香1-20份、桑寄生1-20份、苦参1-20份、当归1-20份、三七1-20份、桂枝1-20份、紫苏1-20份、鱼腥草1-20份、大黄1-20份、桑叶1-20份、杏仁1-20份。
所述治疗鼻炎的中药组合物,其所述中药制剂中各种原料药的重量份数可以优选为:川芎1-15份、麝香1-15份、冰片1-15份、苍耳子1-15份、麻黄1-15份、细辛1-15份、薄荷1-15份、黄柏1-15份、党参1-15份、甘草1-15份、黄芩1-15份、益母草1-15份、金银花1-15份、地榆1-15份、大枣1-15份、徐长卿1-15份、白芷1-15份、辛夷1-15份、瓜蒌1-15份、羌活1-15份、虎杖1-15份、芦荟1-15份、防风1-15份、枸杞1-15份、五味子1-15份、干姜1-15份、黄精1-15份、鹅不食草1-15份、桔梗1-15份、贝母1-15份、沙苑子1-15份、莪术1-15份、没药1-15份、血竭1-15份、乳香1-15份、桑寄生1-15份、苦参1-15份、当归1-15份、三七1-15份、桂枝1-15份、紫苏1-15份、鱼腥草1-15份、大黄1-15份、桑叶1-15份、杏仁1-15份。
所述治疗鼻炎的中药组合物,其所述中药制剂中各种原料药的重量份数还可以优选为:川芎1-10份、麝香1-10份、冰片1-10份、苍耳子1-10份、麻黄1-10份、细辛1-10份、薄荷1-10份、黄柏1-10份、党参1-10份、甘草1-10份、黄芩1-10份、益母草1-10份、金银花1-10份、地榆1-10份、大枣1-10份、徐长卿1-10份、白芷1-10份、辛夷1-10份、瓜蒌1-10份、羌活1-10份、虎杖1-10份、芦荟1-10份、防风1-10份、枸杞1-10份、五味子1-10份、干姜1-10份、黄精1-10份、鹅不食草1-10份、桔梗1-10份、贝母1-10份、沙苑子1-10份、莪术1-10份、没药1-10份、血竭1-10份、乳香1-10份、桑寄生1-10份、苦参1-10份、当归1-10份、三七1-10份、桂枝1-10份、紫苏1-10份、鱼腥草1-10份、大黄1-10份、桑叶1-10份、杏仁1-10份。
所述治疗鼻炎的中药组合物,其所述中药制剂的剂型可以为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
为解决上述技术问题,本发明还提供治疗鼻炎的中药组合物的制备方法,所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁放入乙醇中浸泡,热提取2次,成膏状,为组分1;
b、药渣水提取2次,浓缩过滤为膏状,为组分2;
c、将上述两种膏状浓缩成糊状,加入血竭、麝香、冰片,灭菌,再加入糊精,然后真空冷冻密封。
所述步骤a中,取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1。
所述步骤b中,将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2。
所述步骤c中,将上述两种组分膏状浓缩成糊状,加入血竭、麝香、冰片,用CO 60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
为解决上述技术问题,本发明也提供治疗鼻炎的中药组合物的制备方法,所述制剂剂型为胶囊剂,其制备方法的包括:
a.将所述原料川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁放入粉碎机粉碎后过筛;
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取1次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;加入血竭、麝香、冰片,混合过筛得到的药粉装入胶囊制为胶囊剂。
为解决上述技术问题,本发明也提供治疗鼻炎的中药组合物的制备方法,所述内服药物的剂型为丸剂,其制备步骤包括:
a.将所述原料药川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁混合,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉、血竭、麝香、冰片,合并加入蜂蜜搓成丸剂。
所述治疗鼻炎的中药组合物,其所述中药的使用方法为,本发明做煎汤剂服用时,每日1剂,水煎分两次服,每10天为一疗程;胶囊剂、片剂、丸剂使用时,每次1片、1粒或1丸,每日三次,每7日为一疗程。
本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明各原料有效成份相互影响、协同作用,对鼻炎患者有很好的治疗效果。而且本发明中药制备方法简单、配伍严谨、药性平和、安全无副作用、成本低廉,适宜各类人群服用,便于在临床上大面积推广应用。
具体实施方式
鼻炎,中医名鼻渊、脑漏、脑渗、脑崩、控脑砂、脑砂等。本病的发生,外因感受风寒、风热之邪,内因脏腑功能失调,主要与肺、胃、肝、胆、脾等脏腑邪实或虚损有关。鼻渊以热证居多,病久可以伤气,多与肺有关。鼻渊的辨证要点首分虚实。一般暴起,初病,体质壮实者多为实证;久病,体弱,病情缠绵,时轻时重者多虚中夹实,纯虚者少。实证应分清风、湿、热的偏重;虚证要注意气虚、阴虚、阳虚的不同,同时还须辨别与肺、胆、脾(胃)、肾的关系。
川芎:性味:辛,温。归经:归肝、胆、心包经。功能主治:活血行气,祛风止痛。用于月经不调,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
麝香:温、无毒、味苦。入心、脾、肝经,有开窍、辟秽、通络、散淤之功能。主治中风、痰厥、惊痫、中恶烦闷、心腹暴痛、跌打损伤、痈疽肿毒。
冰片:功能主治:开窍,辟秽,通络,散瘀。治中风,痰厥,惊痫,中恶烦闷,心腹暴痛,癥瘕癖积,跌打损伤,痈疽肿毒
苍耳子:性味:辛、苦,温;有毒。归经:归肺经。功能主治:苍耳子:散风除湿,通鼻窍。用于风寒头痛,鼻渊流涕,风疹瘙痒,湿痹拘挛。
麻黄:麻黄:性味:辛、微苦,温。归经:归肺、膀胱经。功能主治:发汗散寒,宣肺平喘,利水消肿。用于风寒感冒,胸闷喘咳,风水浮肿;支气管哮喘。蜜麻黄润肺止咳。多用于表症已解,气喘咳嗽。
细辛:性味:辛,温。归经:归心、肺、肾经。功能主治:祛风散寒,通窍止痛,温肺化饮。用于风寒感冒,头痛,牙痛,鼻塞鼻渊,风湿痹痛,痰饮喘咳。
薄荷:性味:辛,凉。归经:归肺、肝经。功能主治:宣散风热。清头目,透疹。用于风热感冒,风温初起,头痛,目赤,喉痹,口疮,风疹,麻疹,胸胁胀闷。
黄柏:性味:苦,寒。归经:归肾、膀胱经。功能主治:清热燥湿,泻火除蒸,解毒疗疮。用于湿热泻痢,黄疸,带下,热淋,脚气,痿{辟},骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹瘙痒。盐黄柏滋阴降火。用于阴虚火旺,盗汗骨蒸。《本草经疏》:"阴阳两虚之人,病兼脾胃薄弱,饮食少进及食不消,或兼泄泻,或恶冷物及好热食;肾虚天明作泄;上热下寒,小便不禁;少腹冷痛,子宫寒;血虚不孕,阳虚发热,瘀血停滞,产后血虚发热,金疮发热;痈疽溃后发热,伤食发热,阴虚小水不利,痘后脾虚小水不利,血虚不得眠,血虚烦躁,脾阴不足作泄等证,法咸忌之。"
党参:党参:性味:甘,平。①《本经逢原》:"甘,平。"②《本草再新》:"甘,平,无毒。"归经:《得配本草》:"入手、足太阴经气分。"功能主治:补中,益气,生津。治脾胃虚弱,气血两亏,体倦无力,食少,口渴,久泻,脱肛。①《本经逢原》:"清肺。"②《本草从新》:"补中益气,和脾胃,除烦渴。"③《纲目拾遗》:"治肺虚,益肺气。"④《科学的民间药草》:"补血剂。适用于慢性贫血,萎黄病,白血病,腺病,佝偻病。"⑤《中药材手册》:"治虚劳内伤,肠胃中冷,滑泻久痢,气喘烦渴,发热自汗,妇女血崩、胎产诸病。"
甘草:性味:甘,平。①《本经》:"味甘,平。"②《别录》:"无毒。"③《本草衍义》:"微凉。"④《珍珠囊》:"生甘,平;炙甘,温。"归经:入脾、胃、肺经。①《汤液本草》:"入足厥阴、太阴、少阴经。"②《雷公炮制药性解》:"入心、脾二经。"③《本草通玄》:"入脾、胃。"④《本草经 解》:"入手太阴肺经、足太阴脾经。"功能主治:和中缓急,润肺,解毒,调和诸药。炙用,治脾胃虚弱,食少,腹痛便溏,劳倦发热,肺痿咳嗽,心悸,惊痫;生用,治咽喉肿痛,消化性溃疡,痈疽疮疡,解药毒及食物中毒。
黄芩:性味:苦,寒。归经:归肺、胆、脾、大肠、小肠经。功能主治:清热燥湿,泻火解毒,止血,安胎。用于湿温、暑温胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。
益母草:性味:苦、辛,微寒。归经:归肝、心包经。功能主治:活血调经,利尿消肿。用于月经不调,痛经,经闭,恶露不尽,水肿尿少;急性肾炎水肿。
金银花:金银花:性味:甘,寒。归经:归肺、心、胃经。功能主治:清热解毒,凉散风热。用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
地榆:性味:苦、酸、涩,微寒。功能主治:凉血止血,解毒敛疮。用于便血,痔血,血痢,崩漏,水火烫伤,痈肿疮毒。
大枣:性温、味甘,具益气补血、健脾和胃、袪风功效,对治疗过敏性紫癜、贫血、高血压、急慢性肝炎和肝硬化患者的血清转氨酶增高,以及预防输血反应等均有理想效果;大枣含有三萜类化合物及环磷酸腺苷,有较强的抑癌、抗过敏作用;枣中含有抗疲劳作用的物质,能增强人的耐力;枣还具有减轻毒性物质对肝脏损害的功效;枣中的黄酮类化合物,有镇静降血压的作用。
徐长卿:性味:辛,温。归经:归肝、胃经。功能主治:祛风化湿,止痛止痒。用于风湿痹痛,胃痛胀满,牙痛,腰痛,跌扑损伤,荨麻疹、湿疹。
白芷:性味:辛,温。归经:归胃、大肠、肺经。功能主治:散风除湿,通窍止痛,消肿排脓。用于感冒头痛,眉棱骨痛,鼻塞,鼻渊,牙痛,白带,疮疡肿痛。
辛夷:性味:辛,温。归经:归肺、胃经。功能主治:散风寒,通鼻窍。用于风寒头痛,鼻塞,鼻渊,鼻流浊涕。
瓜蒌:性味:甘、微苦、寒。归经:归肺、胃、大肠经。功能主治:清热涤痰,宽胸散结,润燥滑肠。用于肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结。
羌活:性味:辛、苦,温。归经:归膀胱、肾经。功能主治:散寒,祛风,除湿,止痛。用于风寒感冒头痛,风湿痹痛,肩背酸痛。
虎杖:祛风,利湿,破瘀,通经。治风湿筋骨疼痛,湿热黄疸,淋浊带下,妇女经闭,产后恶露不下,症瘕积聚,痔漏下血。跌扑损伤,烫伤,恶疮癣疾。
芦荟:性味:苦,寒。归经:归肝、胃、大肠经。功能主治:清肝热,通便。用于便秘,小儿疳积,惊风;外治湿癣。
防风:性味:辛、甘,温。归经:归膀胱、肝、脾经。功能主治:解表祛风,胜湿,止痉。用于感冒头痛,风湿痹痛,风疹瘙痒,破伤风。
枸杞:味甘,性平。入肝、肾经。滋肾,润肺,补肝,明目。治肝肾阴亏,腰膝酸软,头晕,目眩,目昏多泪,虚劳咳嗽,消渴,遗精。
五味子:性味:酸、甘,温。归经:归肺,心、肾经。功能主治:收敛固涩,益气生津,补肾宁心。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内热消渴,心悸失眠。
干姜:性味:辛、热。归经:归脾、胃、肾、心、肺经。功能主治:干姜温中散寒,回阳通脉,燥湿消痰。用于脘腹冷痛,呕吐泄泻,肢冷脉微,痰饮喘咳。
黄精:性味:甘,平。归经:归脾、肺、肾经。功能主治:补气养阴,健脾,润肺,益肾。用于脾胃虚弱,体倦乏力,口干食少,肺虚燥咳,精血不足,内热消渴。
鹅不食草:性味:辛,温。归经:归肺、肝经。功能主治:通鼻窍,止咳,用于风寒头痛,咳嗽痰多,鼻塞不通,鼻渊流涕
桔梗:性味:苦、辛,平。归经:归肺经。功能主治:宣肺,利咽,祛痰,排脓。用于咳嗽痰多,胸闷不畅,咽痛,音哑,肺痈吐脓,疮疡脓成不溃。
贝母:性味:《本草正》:"味大苦,性寒。"归经:《本草正》:"入手太阴、少阳,足阳明、厥阴。"功能主治:清热化痰,散结解毒。治风热咳嗽,肺痈喉痹,瘰疬,疮疡肿毒。①《本草正》:"大治肺痈肺萎,咳喘,吐血,衄血,最降痰气,善开郁结,止疼痛,消胀满,清肝火,明耳目,除时气烦热,黄疸淋闭,便血溺血;解热毒,杀诸虫及疗喉痹,瘰疬,乳痈发背,一切痈疡肿毒,湿热恶疮,痔漏,金疮出血,火疮疼痛,较之川贝母,清降之功,不啻数倍。"②《本草从新》:"去时感风痰。"③《纲目拾遗》:"解毒利痰,开宣肺气,凡肺家夹风火有痰者宜此。"④《山东中草药手册》:"清肺化痰,制酸,解毒。治感冒咳嗽,胃痛吐酸,痈毒肿痛。"
沙苑子:补肝,益肾,明目,固精。治肝肾不足,腰膝酸痛,目昏,遗精早泄,小便频数,遗尿,尿血,白带。
莪术:性味:味辛;苦;性温。归经:归肝、脾经。功能主治:行气破血;消积止痛。主血气心痛;饮食积滞;脘腹胀痛;血滞经闭;痛经;症瘕瘤痞块;跌打损伤。
没药:性味:苦,平。①《药性论》:"味苦辛。"②《海药本草》:"味苦辛,温,无毒。"③《开宝本草》:"味苦,平,无毒。"归经:入肝经。①《本草经疏》:"入足厥阴经。"②《本草新编》:"入脾、肾二经。"③《本草求真》:"入心、肝。"功能主治:散血去瘀,消肿定痛。治跌损,金疮,筋骨,心腹诸痛,症瘕,经闭,痈疽肿痛,痔漏,目障。
血竭:血竭:性味:甘咸,平。①《雷公炮炙论》:"味微咸甘。"②《唐本草》:"味甘咸,平,有小毒。"③《本草蒙筌》:"味辛咸,气平,有小毒。"归经:入心、肝经。①《纲目》:"手足厥阴。"②《本草经疏》:"入足厥阴,手少阴经。"③《本草新编》:"入肾。"功能主治:散瘀定痛,止血生肌。治跌打折损,内伤瘀痛;外伤出血不止,瘰疬,臁疮溃久不合。
乳香:乳香:性味:辛苦,温。①《别录》:"微温。"②《日华子本草》:"味辛,热,微毒。"③李杲:"味苦辛,热。"归经:入心、肝、脾经。①朱震亨:"入手少阴经。"②《本草经疏》:"入足太阴、手少阴,兼入足厥阴经。"功能主治:调气活血,定痛,追毒。治气血凝滞、心腹疼痛,痈疮肿毒,跌打损伤,痛经,产后瘀血刺痛。
桑寄生:性味:苦、甘,平。归经:归肝、肾经。功能主治:补肝肾,强筋骨,祛风湿,安胎元。用于风湿痹痛,腰膝酸软,筋骨无力,崩漏经多,妊娠漏血,胎动不安;高血压。
苦参:性味:苦,寒。归经:归心、肝、胃、大肠、膀胱经。功能主治:清热燥湿,杀虫,利尿。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风;外治滴虫性阴道炎。
当归:性味:甘、辛,温。归经:归肝、心、脾经。功能主治: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。
三七:性味:甘、微苦,温。归经:归肝、胃经。功能主治:散瘀止血,消肿定痛。用于咯血,吐血,衄血,便血,崩漏,外伤出血,胸腹剌痛,跌扑肿痛。
桂枝:性味:辛、甘,温。归经:归心、肺、膀胱经。功能主治:发汗解肌,温通经脉,助阳化气,平冲降气。用于风寒感冒,脘腹冷痛,血寒经闭,关节痹痛,痰饮,水肿,心悸,奔豚。
紫苏:性味:辛,温。归经:归肺经。功能主治:降气消痰,平喘,润肠。用于痰壅气逆,咳嗽气喘,肠燥便秘。
鱼腥草:性味:辛,微寒。归经:归肺经。功能主治:清热解毒,消痈排脓,利尿通淋。用于肺痈吐脓,痰热喘咳,热痢,热淋,痈肿疮毒。
大黄:性味:苦,寒。归经:归脾、胃、大肠、肝、心包经。功能主治:泻热通肠,凉血解毒,逐瘀通经。用于实热便秘,积滞腹痛,泻痢不爽,湿热黄疸,血热吐衄,目赤,咽肿,肠痈腹痛,痈肿疔疮,瘀血经闭,跌打损伤,外治水火烫伤;上消化道出血。酒大黄善清上焦血分热毒。用于目赤咽肿,齿龈肿痛。熟大黄泻下力缓,泻火解毒。用于火毒疮疡。大黄炭凉血化瘀止血。用于血热有瘀出血症。
桑叶:性味:苦甘,寒。①《日华子本草》:"暖,无毒。"②《纲目》:"味苦甘,寒,有小毒。"③《医林纂要》:"甘酸辛,寒。"归经:入肺、肝经。功能主治:祛风清热,凉血明目。治风温发热,头痛,目赤,口渴,肺热咳嗽,风痹,瘾疹,下肢象皮肿。
杏仁:性味:苦,微温;有小毒。归经:归肺、大肠经。功能主治:降气止咳平喘,润肠通便。用于咳嗽气喘,胸满痰多,血虚津枯,肠燥便秘。
下面结合具体实施例对本发明做进一步阐述。
实施例1
川芎1份、麝香1份、冰片1份、苍耳子1份、麻黄1份、细辛1份、薄荷3份、黄柏1份、党参1份、甘草3份、黄芩3份、益母草3份、金银花3份、地榆1份、大枣1份、徐长卿1份、白芷1份、辛夷3份、瓜蒌3份、羌活1份、虎杖1份、芦荟1份、防风1份、枸杞1份、五味子1份、干姜1份、黄精1份、鹅不食草1份、桔梗1份、贝母1份、沙苑子1份、莪术1份、没药1份、血竭1份、乳香1份、桑寄生1份、苦参1份、当归1份、三七3份、桂枝1份、紫苏1份、鱼腥草1份、大黄3份、桑叶1份、杏仁2份。
所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1。
b、将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2。
c、将上述两种膏状浓缩成糊状,加入血竭、麝香、冰片,灭菌,再加入糊精,用CO 60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
实施例2
a.将所述原料川芎1份、苍耳子1份、麻黄1份、细辛1份、薄荷3份、黄柏1份、党参1份、甘草3份、黄芩3份、益母草3份、金银花3份、地榆1份、大枣1份、徐长卿1份、白芷1份、辛夷3份、瓜蒌3份、羌活1份、虎杖1份、芦荟1份、防风1份、枸杞1份、五味子1份、干姜1份、黄精1份、鹅不食草1份、桔梗1份、贝母1份、沙苑子1份、莪术1份、没药1份、乳香1份、桑寄生1份、苦参1份、当归1份、三七3份、桂枝1份、紫苏1份、鱼腥草1份、大黄3份、桑叶1份、杏仁2份放入粉碎机粉碎后过筛;
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取1次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;加入血竭1份、麝香1份、冰片1份,混合过筛得到的药粉装入胶囊制为胶囊剂。
实施例3
a.将所述原料川芎1份、苍耳子1份、麻黄1份、细辛1份、薄荷3份、黄柏1份、党参1份、甘草3份、黄芩3份、益母草3份、金银花3份、地榆1份、大枣1份、徐长卿1份、白芷1份、辛夷3份、瓜蒌3份、羌活1份、虎杖1份、芦荟1份、防风1份、枸杞1份、五味子1份、干姜1份、黄精1份、鹅不食草1份、桔梗1份、贝母1份、沙苑子1份、莪术1份、没药1份、乳香1份、桑寄生1份、苦参1份、当归1份、三七3份、桂枝1份、紫苏1份、鱼腥草1份、大黄3份、桑叶1份、杏仁2份,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉、血竭1份、麝香1份、冰片1份,合并加入蜂蜜搓成丸剂。
药理学毒性试验
1、急性毒性试验
应用小鼠进行急性毒性实验表明:小鼠口服灌胃本发明的中药制剂胶囊剂,在488.8g生药/kg剂量下,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,实验结果表明:小鼠口服灌胃本发明的中药制剂胶囊剂的最大给药量为488.8g生药/kg/d(LD50>488.8g生药/kg)。本发明的中药制剂每日临床用药总量为0.1g生药/kg/d;按体重计,小鼠灌胃本发明的中药制剂的耐受量为临床病人的4888倍。提示该药急性毒性低,临床用药安全。
2、长期毒性试验
选用SD大鼠,给予不同浓度(18.0、6.0、2.0g生药/kg)的本发明的中药制剂胶囊剂,每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果本发明的中药制剂在高、中、低三个剂量(18.0、6.0、2.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性较高。
临床试验
一般资料
为了验证本发明中药组合物的效果,在青岛市多名专家的共同研究和指导下,自2008年3月至2015年11月,对360例鼻炎患者进行临床观察治疗,其中,男190例,女170例。
诊断标准:
诊断依据国家中医药管理局颁发的《中医病证诊断疗效标准》。
治疗方法:
对照组:空白组口服安慰剂胶囊,早晚各一次。疗程14天。
治疗组:服用本发明实施例3药物,每天分三次饭后口服,疗程14天。两组分别治疗后,观察临床症状与各项辅助检查等改善情况。
疗效评价:
(1)治愈:炎症全部消失,症状恢复正常。
(2)显效:炎症消失,症状基本恢复正常。
(3)有效:炎症基本消失,症状部分好转。
(4)无效:通过治疗后症状无明显好转。。
统计学方法:数据用率表示,采用X2检验,以P<0.05为差异有统计学意义。
结果:
治疗前后两组症状改善情况比较
表1两组疗效比较n(%)
以上治疗组未见明显不良反应。
以上数据显著说明了本发明各原料有效成份相互影响、协同作用,对鼻炎患者有很好的治疗效果。以上所述,仅是本发明的最佳实施例而已,并非对本发明作任何形式上的限制,任何熟悉本领域的技术人员,在不脱离本发明技术方案范围情况下,利用上述揭示的方法内容对本发明技术方案做出许多可能的变动和修饰,均属于权利要求书保护的范围。
Claims (10)
1.一种治疗鼻炎的中药制剂,其特征在于:由以下各组分组成:
川芎1-20份、麝香1-20份、冰片1-20份、苍耳子1-20份、麻黄1-20份、细辛1-20份、薄荷1-20份、黄柏1-20份、党参1-20份、甘草1-20份、黄芩1-20份、益母草1-20份、金银花1-20份、地榆1-20份、大枣1-20份、徐长卿1-20份、白芷1-20份、辛夷1-20份、瓜蒌1-20份、羌活1-20份、虎杖1-20份、芦荟1-20份、防风1-20份、枸杞1-20份、五味子1-20份、干姜1-20份、黄精1-20份、鹅不食草1-20份、桔梗1-20份、贝母1-20份、沙苑子1-20份、莪术1-20份、没药1-20份、血竭1-20份、乳香1-20份、桑寄生1-20份、苦参1-20份、当归1-20份、三七1-20份、桂枝1-20份、紫苏1-20份、鱼腥草1-20份、大黄1-20份、桑叶1-20份、杏仁1-20份。
2.根据权利要求1所述的一种治疗鼻炎的中药制剂,其特征在于:由以下重量份数的各组分组成:
川芎1-15份、麝香1-15份、冰片1-15份、苍耳子1-15份、麻黄1-15份、细辛1-15份、薄荷1-15份、黄柏1-15份、党参1-15份、甘草1-15份、黄芩1-15份、益母草1-15份、金银花1-15份、地榆1-15份、大枣1-15份、徐长卿1-15份、白芷1-15份、辛夷1-15份、瓜蒌1-15份、羌活1-15份、虎杖1-15份、芦荟1-15份、防风1-15份、枸杞1-15份、五味子1-15份、干姜1-15份、黄精1-15份、鹅不食草1-15份、桔梗1-15份、贝母1-15份、沙苑子1-15份、莪术1-15份、没药1-15份、血竭1-15份、乳香1-15份、桑寄生1-15份、苦参1-15份、当归1-15份、三七1-15份、桂枝1-15份、紫苏1-15份、鱼腥草1-15份、大黄1-15份、桑叶1-15份、杏仁1-15份。
3.根据权利要求1至2所述的一种治疗鼻炎的中药制剂,其特征在于:由以下重量份数的各组分组成:
川芎1-10份、麝香1-10份、冰片1-10份、苍耳子1-10份、麻黄1-10份、细辛1-10份、薄荷1-10份、黄柏1-10份、党参1-10份、甘草1-10份、黄芩1-10份、益母草1-10份、金银花1-10份、地榆1-10份、大枣1-10份、徐长卿1-10份、白芷1-10份、辛夷1-10份、瓜蒌1-10份、羌活1-10份、虎杖1-10份、芦荟1-10份、防风1-10份、枸杞1-10份、五味子1-10份、干姜1-10份、黄精1-10份、鹅不食草1-10份、桔梗1-10份、贝母1-10份、沙苑子1-10份、莪术1-10份、没药1-10份、血竭1-10份、乳香1-10份、桑寄生1-10份、苦参1-10份、当归1-10份、三七1-10份、桂枝1-10份、紫苏1-10份、鱼腥草1-10份、大黄1-10份、桑叶1-10份、杏仁1-10份。
4.根据权利要求1至3所述的一种治疗鼻炎的中药制剂,其特征在于:所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
5.根据权利要求1至4所述的一种治疗鼻炎的中药制剂的制备方法,其特征在于:所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁放入乙醇中浸泡,热提取2次,成膏状,为组分1;
b、药渣水提取2次,浓缩过滤为膏状,为组分2;
c、将上述两种膏状浓缩成糊状,加入血竭、麝香、冰片,灭菌,再加入糊精,然后真空冷冻密封。
6.根据权利要求5所述的一种治疗鼻炎的中药制剂的制备方法,其特征在于:所述步骤a中,取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1。。
7.根据权利要求5所述的一种治疗鼻炎的中药制剂的制备方法,其特征在于:所述步骤b中,将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2。
8.根据权利要求5所述的一种治疗鼻炎的中药制剂的制备方法,其特征在于:所述步骤c中,将上述两种组分膏状浓缩成糊状,加入血竭、麝香、冰片,用CO 60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
9.一种如权利要求1至8所述的治疗鼻炎的中药制剂的制备方法,其特征在于,所述制剂剂型为胶囊剂,其制备方法的包括:
a.将所述原料川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁放入粉碎机粉碎后过筛;
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取1次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;加入血竭、麝香、冰片,混合过筛得到的药粉装入胶囊制为胶囊剂。
10.一种如权利要求1至9所述的治疗鼻炎的中药制剂的制备方法,其特征在于,所述内服药物的剂型为丸剂,其制备步骤包括:
a.将所述原料药川芎、苍耳子、麻黄、细辛、薄荷、黄柏、党参、甘草、黄芩、益母草、金银花、地榆、大枣、徐长卿、白芷、辛夷、瓜蒌、羌活、虎杖、芦荟、防风、枸杞、五味子、干姜、黄精、鹅不食草、桔梗、贝母、沙苑子、莪术、没药、乳香、桑寄生、苦参、当归、三七、桂枝、紫苏、鱼腥草、大黄、桑叶、杏仁混合,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉、血竭、麝香、冰片,合并加入蜂蜜搓成丸剂。
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CN107518713A (zh) * | 2017-08-16 | 2017-12-29 | 安徽省康福枕业有限公司 | 一种用于治疗慢性鼻炎的药枕及其制备方法 |
CN108498690A (zh) * | 2018-06-25 | 2018-09-07 | 利辛县运杰家庭农场 | 一种治疗慢性鼻炎的中药组合物及其制备方法 |
CN108524820A (zh) * | 2018-06-06 | 2018-09-14 | 唐水金 | 一种治疗鼻炎的药物 |
CN109045130A (zh) * | 2018-09-11 | 2018-12-21 | 泉州市智棱生物科技有限公司 | 一种抗菌消炎的鼻炎药膏及其制备方法 |
CN110946952A (zh) * | 2019-12-25 | 2020-04-03 | 北京辨证堂中医药研究院 | 一种治疗过敏性鼻炎鼻窦炎鼻息肉的纯中药鼻炎膏 |
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CN104173638A (zh) * | 2014-09-15 | 2014-12-03 | 樊万军 | 一种治疗鼻炎的中药组合物 |
CN105311527A (zh) * | 2015-12-02 | 2016-02-10 | 青岛友诚高新技术有限公司 | 一种用于治疗子宫内膜移位症的中药制剂及其制备方法 |
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CN104173638A (zh) * | 2014-09-15 | 2014-12-03 | 樊万军 | 一种治疗鼻炎的中药组合物 |
CN105311527A (zh) * | 2015-12-02 | 2016-02-10 | 青岛友诚高新技术有限公司 | 一种用于治疗子宫内膜移位症的中药制剂及其制备方法 |
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CN107518713A (zh) * | 2017-08-16 | 2017-12-29 | 安徽省康福枕业有限公司 | 一种用于治疗慢性鼻炎的药枕及其制备方法 |
CN108524820A (zh) * | 2018-06-06 | 2018-09-14 | 唐水金 | 一种治疗鼻炎的药物 |
CN108498690A (zh) * | 2018-06-25 | 2018-09-07 | 利辛县运杰家庭农场 | 一种治疗慢性鼻炎的中药组合物及其制备方法 |
CN109045130A (zh) * | 2018-09-11 | 2018-12-21 | 泉州市智棱生物科技有限公司 | 一种抗菌消炎的鼻炎药膏及其制备方法 |
CN110946952A (zh) * | 2019-12-25 | 2020-04-03 | 北京辨证堂中医药研究院 | 一种治疗过敏性鼻炎鼻窦炎鼻息肉的纯中药鼻炎膏 |
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Application publication date: 20170104 |