CN116350734B - 一种辅助治疗肺结节的制剂及其制备和使用方法及应用 - Google Patents
一种辅助治疗肺结节的制剂及其制备和使用方法及应用 Download PDFInfo
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- CN116350734B CN116350734B CN202310578724.3A CN202310578724A CN116350734B CN 116350734 B CN116350734 B CN 116350734B CN 202310578724 A CN202310578724 A CN 202310578724A CN 116350734 B CN116350734 B CN 116350734B
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- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
本发明公开了一种辅助治疗肺结节的制剂及其制备方法、使用方法和应用,属于中医药技术领域。该试剂是基于肺结节“肺气亏虚、痰瘀互结”的基本病机,以温阳通络、活血行气、攻逐瘀滞、消散结聚为治则。白芥子善走散以消痰;三棱、莪术相须为用,化瘀消积、破气散结;姜黄行气通经;三药相合,活血行气、攻逐瘀滞;黄芪补气升阳。辅以细辛、苏子及夏枯草,共奏降气化痰、消散结聚之功;辅以三七及王不留行,活血化瘀、行气通经;佐以半枝莲及白花蛇舌草,化瘀通络;石斛滋阴生津,辛凉之冰片、黄芩及芙蓉叶清肺消肿、通利肺络,既可使寒热相配、阴阳和济。通过制备得到获得外用膏药进行贴敷使用。用于肺结节的辅助保健,具有较大临床意义及价值。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种辅助治疗肺结节的制剂及其制备方法、使用方法和应用。
背景技术
肺结节,是指直径≤3cm的局灶性、密度增高的实性或亚实性肺部阴影,可孤立或多发。随着公众体检意识逐渐增强,以及低剂量CT的普及应用,肺结节检出率明显上升。研究显示,国内肺结节CT检出率约在9.6%-79.79%,国外检出率在2.3%-59.7%,其发病率增加与年龄增长、吸烟史、既往肿瘤史及工作生活环境等危险因素密切相关。目前现代医学主要采用定期随访观察方法对肺结节进行管理,对于高危结节可采用手术切除、介入辅助治疗等方法进行干预辅助治疗,对非高危结节尚无有效辅助治疗手段。出于对高危肺结节(肺癌)的恐惧,肺结节患者往往有极大的心理压力,迫切寻求安全有效的干预方法。
中医学多将肺结节归属于“肺积”的中医病名,属中医有形之物范畴,“积聚者,由阴阳不和”(《诸病源候论·积聚病诸候》),其形成与肺络“阳化气,阴成形”功能异常密切相关。“邪之所凑,其气必虚”(《素问·评热论》),“积者,阴气也”(《难经·五十五难》),肺结节的形成过程即阳化气不足、阴成形太过的过程。《杂病源流犀烛·积聚症瘕痃癖痞源流》曰:“邪积胸中,阻塞气道,气不得通,为痰,为食,为血,皆邪正相搏,邪既胜,正不得制之,遂结成形而有块”,正气亏虚,气滞、痰阻、瘀血等病理产物相互搏结,聚则成块为结节,故肺气亏虚、痰瘀互结当为肺结节形成的基本病机。
穴位贴敷是传统中医外治法的代表,具有无创、无痛、简便效廉的特点,其透皮给药不经胃肠道的方式可避免肝的首过效应,药物的生物利用度高,穴位贴敷可通过刺激经络、疏通气血及药物透皮吸收、直接作用靶器官的方式,起到通络散结的功效,临床常将此方法用于慢性阻塞性肺疾病、支气管哮喘、过敏性鼻炎等疾病稳定期作为巩固辅助治疗,但目前尚未见穴位贴敷辅助治疗肺结节疾病的相关报道。
发明内容
本发明的第一目的在于提供一种辅助治疗肺结节的制剂,该制剂是以温阳通络、消散结聚为主,选用化痰、散结、理气、通络作用的药物,经混合浓缩做成膏剂,再进行病灶局部外敷,通过皮肤导入作用,到达病灶,调理病灶气血、消散病灶痰瘀的功效。解决了现有产品治疗效果不佳的技术问题。
本发明的第二目的在于提供一种辅助治疗肺结节的制剂在制备穴位贴敷产品、外用保健贴产品中的应用,通过利用穴位敷贴的应用方式,提高辅助治疗效果的同时也提高了产品的运输和保存。
本发明通过以下技术方案实现:
一种辅助治疗肺结节的制剂,所述制剂主要由以下质量份数的原料制备得到:
白芥子5-20份,细辛5-20份,炒紫苏子10-40份,夏枯草15-60份,三棱15-60份,莪术15-60份,三七5-20份,姜黄10-40份,王不留行10-40份,芙蓉叶15-60份,冰片5-20份,黄芩15-60份,黄芪15-60份,石斛15-60份,半枝莲15-60份和白花蛇舌草15-60份。
方解:中医认为,肺结节表现为正气虚损为本,痰瘀阻肺为标,其病位在肺,与脾密切相关,故选药以温阳通络、消散结聚为主,一般选用化痰、散结、理气、通络作用的药物,经混合浓缩做成膏剂,再进行肺结节病灶的局部外敷,通过皮肤的导入作用,可以到达病灶,从而调理病灶气血、消散病灶痰瘀。上述该制剂是以《张氏医通》“冷哮灸”方、三子养亲汤等经典名方化裁。
其中:白芥子,善走散以消痰,宽胸膈而利气,其性温辛散之性又可达肝,《本草新编》载“白芥子消膜膈之痰,是有痰之处无不尽消”,此药温阳通络,以消皮里膜外之痰。三棱、莪术相须为用,功擅化瘀消积、破气散结,《开宝本草》载其“主老癖癥瘕结块”,姜黄辛苦性温,行气通经,善治“癥瘕血块”(《日华子本草》),此三药相合,可活血行气、攻逐瘀滞;黄芪补气升阳,使肺气旺而肌表固实,以绝虚邪贼风外犯,乃诸补药之长,且现代研究显示此药有助于调节免疫,改善体质,增强抗癌能力。此外,辅以细辛、苏子及夏枯草,共奏降气化痰、消散结聚之功;辅以三七及王不留行,增强活血化瘀、行气通经之效;佐以半枝莲及白花蛇舌草,可化瘀通络、消散癌毒,予甘寒之石斛滋阴生津,辛凉之冰片、黄芩及芙蓉叶清肺消肿、通利肺络,既可使寒热相配、阴阳和济,亦可佐制他药过于燥热。
作为优选地,所述制剂主要由以下质量份数的原料制备得到:
白芥子8-15份,细辛8-15份,炒紫苏子16-30份,夏枯草24-45份,三棱24-45份,莪术24-45份,三七8-15份,姜黄16-30份,王不留行16-30份,芙蓉叶24-45份,冰片8-15份,黄芩24-45份,黄芪24-45份,石斛24-45份,半枝莲24-45份和白花蛇舌草24-45份。
作为优选地,所述制剂主要由以下质量份数的原料制备得到:
白芥子10份,细辛10份,炒紫苏子20份,夏枯草30份,三棱30份,莪术30份,三七10份,姜黄20份,王不留行20份,芙蓉叶30份,冰片10份,黄芩30份,黄芪30份,石斛30份,半枝莲30份和白花蛇舌草30份。
白芥子,具有温中散寒,豁痰利窍,通络消肿的功效。主治胃寒呕吐,心腹冷痛,咳喘痰多,口噤,耳聋,喉痹,风湿痹痛,肢体麻木,妇人经闭,痈肿,瘰疬。
细辛,具有解表散寒,祛风止痛,通窍,温肺化饮的功效。主治风寒感冒,头痛,牙痛,风湿痹痛,鼻渊,肺寒咳嗽。
炒紫苏子,具有降气化痰,止咳平喘的功效。主治痰壅气逆,咳嗽气喘,肠燥便秘。
夏枯草,具有清热泻火,明目,散结消肿的功效。主治目赤肿痛,头痛眩晕,目珠夜痛,瘰疬,瘿瘤,乳痈肿痛。
三棱,具有破血行气,消积止痛的功效。
莪术,具有行气破血,消积止痛之功效。常用于血气心痛,饮食积滞,脘腹胀痛,血滞经闭,痛经,癓瘕痞块,跌打损伤。
三七,具有化瘀止血,活血定痛的功效。主治各种出血证,瘀血肿痛、跌打损伤等属于瘀血阻滞者。
姜黄,具有活血行气,通经止痛的功效。主治气滞血瘀痛证,风湿痹痛。
王不留行,具有活血通经,下乳消痈,利尿通淋的功效。主治血瘀经闭、痛经、难产,产后乳汁不下,乳痈肿痛,热淋,血淋,石淋。
芙蓉叶,具有清肺凉血,解毒消肿之功效。用于肺热咳嗽,目赤肿痛,痈疽肿毒,恶疮,缠身蛇丹,脓疱疮,肾盂肾炎,水火烫伤,毒蛇咬伤,跌打损伤。
冰片,具有开窍醒神,清热止痛的功效。主治闭证神昏,目赤肿痛,喉痹口疮,疮疡肿痛,疮溃不敛,水火烫伤。
黄芩,具有清热燥湿,泻火解毒,止血,安胎的功效。主治湿温,暑湿,胸闷呕恶,湿热痞满,黄疸泻痢,肺热咳嗽,高热烦渴,血热吐衄,胎动不安。
黄芪,具有健脾补中,升阳举陷,益卫固表,利尿,托毒生肌的功效。主治脾气虚证,肺气虚证,气虚自汗证,气血亏虚,疮疡难溃难腐,或溃久难敛等。
石斛,具有益胃生津,滋阴清热的功效。主治胃阴虚证,热病伤津证,肾阴虚证。
半枝莲,具有清热解毒,散瘀止血,利尿消肿的功效。主治热毒痈肿,咽喉疼痛,肺痈,肠痈,瘰疬,毒蛇咬伤,跌打损伤,吐血,衄血,血淋,水肿,腹水及癌症。
白花蛇舌草,具有清热解毒,利湿通淋的功效。主治痈肿疮毒,咽喉肿痛,毒蛇咬伤,热淋涩痛。
一种根辅助治疗肺结节的制剂的制备方法,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水煎煮、过滤、浓缩、冷却。
作为优选地,所述煎煮温度为85-100℃。
作为优选地,所述煎煮时长为30-45min。
作为优选地,所述煎煮次数为2-3次。
作为优选地,所述冷却后制剂为膏药制剂。
一种辅助治疗肺结节的制剂的使用方法,采用将制剂涂覆在无纺布贴上使用。
一种辅助治疗肺结节的制剂在制备穴位贴敷产品、外用保健贴产品中的应用。
上述穴位贴敷产品使用时,对应的穴位为:风门、肺俞、脾俞、膻中、天突。风门穴位于背部,当第2胸椎棘突下,旁开1.5寸;肺俞穴位于背部,当第3胸椎棘突下,旁开1.5寸;脾俞穴位于背部,当第11胸椎棘突下,旁开1.5寸;膻中穴位于胸部,前正中线,平第4肋间,两乳头连线的中点;天突穴位于颈部,前正中线,胸骨上窝中央。
利用上述该制剂进行贴敷穴位中,风门穴属足太阳膀胱经的经穴,为督脉、足太阳经交会穴,功能作用主要在于调气,特别是湿热之气,而气血运行不畅。肺之背俞穴肺俞以调理宣利肺气、清气化痰,脾之背俞穴脾俞以健运脾胃、以绝痰源。八会穴之气会膻中以通利上焦、宽畅胸膈、降气通络,另以前后配穴法取任脉腧穴天突及督脉腧穴大椎以交通阴阳、调补内脏,以上诸穴同用以补益肺脾之气,通行经络,沟通内外阴阳,使营卫气血运行如常,则结节自消。
与现有技术相比,本发明至少具有如下技术效果:
(一)本发明提供了一种辅助治疗肺结节的制剂,该试剂是基于肺结节“肺气亏虚、痰瘀互结”的基本病机,以具有温阳通络、活血行气、攻逐瘀滞、消散结聚作为主要治则。通过结合白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草结合,通过制备得到获得外用膏药进行贴敷使用。用于肺结节的辅助保健,具有较大临床意义及价值。
(二)该制剂具有如下优点:①直接作用皮肤,使用方便,透皮给药,可使药物渗透作用于靶器官;②不经胃肠道给药,无痛无创,对肝肾功能影响较小,安全性高;③药物可刺激穴位经络,调节全身气血;④简单易行,易于基层推广。
(三)该制剂组方的配伍思想是:在系统阐述了组方所蕴含的中医思维理论,结合使用穴位位置、特点及功能作用,基于中医理论进行组方选穴,简便易行,安全无毒副作用。
(四)该试剂针对直径小于8mm且中低恶性程度、胸部CT检出肺结节人群,旨在通过对特定中医穴位进行贴敷辅助治疗,改善肺结节患者临床症状,促进结节消散。
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,但是本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应视为限制本发明的范围,实施例中未注明的具体条件,按照常规条件或者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,均为可以通过市售购买获得的常规产品。
实施例1:
一种辅助治疗肺结节的制剂由以下质量份数的原料制备得到:
白芥子50克,细辛50克,炒紫苏子100克,夏枯草150克,三棱150克,莪术150克,三七50克,姜黄100克,王不留行100克,芙蓉叶150克,冰片50克,黄芩150克,黄芪150克,石斛150克,半枝莲150克和白花蛇舌草150克。
一种根辅助治疗肺结节的膏药制剂的制备方法,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水在85℃下煎煮45min、煎煮3次,过滤、浓缩、冷却。
采用将膏药涂覆在无纺布贴上使用。
实施例2:
一种辅助治疗肺结节的制剂由以下质量份数的原料制备得到:
白芥子200克,细辛200克,炒紫苏子400克,夏枯草600克,三棱600克,莪术600克,三七200克,姜黄400克,王不留行400克,芙蓉叶600克,冰片200克,黄芩600克,黄芪600克,石斛600克,半枝莲600克和白花蛇舌草600克。
一种根辅助治疗肺结节的膏药制剂的制备方法,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水在100℃下煎煮30min、煎煮2次,过滤、浓缩、冷却。
采用将膏药涂覆在无纺布贴上使用。
实施例3:
一种辅助治疗肺结节的制剂由以下质量份数的原料制备得到:
白芥子80克,细辛80克,炒紫苏子160克,夏枯草240克,三棱240克,莪术240克,三七80克,姜黄160克,王不留行160克,芙蓉叶240克,冰片80克,黄芩240克,黄芪240克,石斛240克,半枝莲240克和白花蛇舌草240克。
一种根辅助治疗肺结节的膏药制剂的制备方法,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水在85℃下煎煮45min、煎煮3次,过滤、浓缩、冷却。
采用将膏药涂覆在无纺布贴上使用。
实施例4:
一种辅助治疗肺结节的制剂由以下质量份数的原料制备得到:
一种辅助治疗肺结节的制剂由以下质量份数的原料制备得到:
白芥子150克,细辛150克,炒紫苏子300克,夏枯草450克,三棱450克,莪术450克,三七150克,姜黄300克,王不留行300克,芙蓉叶450克,冰片150克,黄芩450克,黄芪450克,石斛450克,半枝莲450克和白花蛇舌草450克。
一种根辅助治疗肺结节的膏药制剂的制备方法,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水在100℃下煎煮30min、煎煮2次,过滤、浓缩、冷却。
采用将膏药涂覆在无纺布贴上使用。
实施例5:
一种辅助治疗肺结节的制剂由以下质量份数的原料制备得到:
白芥子100克,细辛100克,炒紫苏子200克,夏枯草300克,三棱300克,莪术300克,三七100克,姜黄200克,王不留行200克,芙蓉叶300克,冰片100克,黄芩300克,黄芪300克,石斛300克,半枝莲300克和白花蛇舌草300克。
一种根辅助治疗肺结节的膏药制剂的制备方法,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水在100℃下煎煮30min、煎煮2次,过滤、浓缩、冷却。
采用将膏药涂覆在无纺布贴上使用。
产品:上述产品可以制作型号规格:圆形:φ2、φ2.5、φ3、φ3.5、φ4、φ5、φ6;方形:4×6、5×7、6×8、7×9、8×10、9×12、10×12、12×15、13×16、14×16、15×17、16×18、17×19、18×20、6×6、10×13、10.5×12.5、11×13(单位:cm)。
保健作用:适用于缓解因胸闷气短,喘咳气逆引起的胸部不适的亚健康人群,通过贴敷相应穴位,具有促进康复和健康的作用。
不适应人群:对本品过敏者,皮肤破损者,婴幼儿、孕妇乳母禁用。
使用方法:外用,将贴敷部位清洁干净,穴位贴敷:肺俞、脾俞、膻中取背部两个穴位(肺俞、脾俞)和前胸一个穴位(膻中),建议每贴使用6-8h,每周2-4次。
本品不代替药品、医疗器械、消毒用品、保健食品和化妆品等使用。
最后应说明的是:以上所述仅为本发明的优选实施例而已,并不用于限制本发明的保护范围。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (9)
1.一种辅助治疗肺结节的制剂,其特征在于,所述制剂由以下质量份数的原料制备得到:
白芥子5-20份,细辛5-20份,炒紫苏子10-40份,夏枯草15-60份,三棱15-60份,莪术15-60份,三七5-20份,姜黄10-40份,王不留行10-40份,芙蓉叶15-60份,冰片5-20份,黄芩15-60份,黄芪15-60份,石斛15-60份,半枝莲15-60份和白花蛇舌草15-60份。
2.根据权利要求1所述的一种辅助治疗肺结节的制剂,其特征在于,所述制剂由以下质量份数的原料制备得到:
白芥子8-15份,细辛8-15份,炒紫苏子16-30份,夏枯草24-45份,三棱24-45份,莪术24-45份,三七8-15份,姜黄16-30份,王不留行16-30份,芙蓉叶24-45份,冰片8-15份,黄芩24-45份,黄芪24-45份,石斛24-45份,半枝莲24-45份和白花蛇舌草24-45份。
3.根据权利要求1所述的一种辅助治疗肺结节的制剂,其特征在于,所述制剂由以下质量份数的原料制备得到:
白芥子10份,细辛10份,炒紫苏子20份,夏枯草30份,三棱30份,莪术30份,三七10份,姜黄20份,王不留行20份,芙蓉叶30份,冰片10份,黄芩30份,黄芪30份,石斛30份,半枝莲30份和白花蛇舌草30份。
4.一种根据权利要求1-3任一项所述的辅助治疗肺结节的制剂的制备方法,其特征在于,包括如下步骤:
按照相应质量份数选取白芥子、细辛、炒紫苏子、夏枯草、三棱、莪术、三七、姜黄、王不留行、芙蓉叶、冰片、黄芩、黄芪、石斛、半枝莲和白花蛇舌草的生料混合后,加水煎煮、过滤、浓缩、冷却。
5.根据权利要求4所述的一种辅助治疗肺结节的制剂的制备方法,其特征在于,所述煎煮温度为85-100℃。
6.根据权利要求5所述的一种辅助治疗肺结节的制剂的制备方法,其特征在于,所述煎煮时长为30-45min。
7.根据权利要求6所述的一种辅助治疗肺结节的制剂的制备方法,其特征在于,所述煎煮次数为2-3次。
8.根据权利要求4所述的一种辅助治疗肺结节的制剂的制备方法,其特征在于,所述冷却后制剂为膏药制剂。
9.一种如权利要求1-3任一项所述的辅助治疗肺结节的制剂在制备穴位贴敷产品、外用保健贴产品中的应用。
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