CN116135216B - 一种治疗颈部脓肿型淋巴结结核的中药组合物 - Google Patents
一种治疗颈部脓肿型淋巴结结核的中药组合物 Download PDFInfo
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Abstract
本发明提供一种治疗颈部脓肿型淋巴结结核的中药组合物,由下列重量份配比的中药原料制备而成:黄芪10‑100重量份,当归10‑50重量份,炒白术10‑40重量份,沙参10‑30重量份,皂角刺10‑30重量份,金银花10‑30重量份,煅牡蛎10‑50重量份,川芎10‑25重量份。能有效治疗淋巴结结核,并改善口干、乏力、气短、盗汗、口苦等症。
Description
技术领域
本发明涉及一种中药,尤其涉及的是一种治疗颈部脓肿型淋巴结结核的中药组合物。
背景技术
中医学认为淋巴结结核属于“瘰疬”病范畴,其多由情志不畅,肝气郁结,痰热内生,结于颈项。病之后期出现肝郁化火,灼伤阴血,热盛肉腐成脓,或肺肾阴亏,阴虚火旺,痰火凝结而成脓。王芷乔等报道瘰疬外用方药的用药规律分析,其中高频药物为乳香、麝香、没药、朱砂、黄丹、麻油等,所用药物四气以温、寒、平药为主,五味以辛、苦、甘为主,药物归经以归肝经、脾经、心经、胃经为主,置信度较高的常用药物组合如没药-麝香-乳香、血竭-乳香、轻粉-麝香等。获得核心药物组合5组,并生成外用新处方备选组合5个,如杏仁-松香-木鳖子-穿山甲、雄黄-麝香-白矾-硇砂-砒霜等。因而,历代医家外治瘰疬医案的组方法则以活血化瘀、拔毒生肌为主。
杨亚静报道了基于数据挖掘分析公开专利中治疗瘰疬方剂的组方用药规律,药频次较高的药物为清热药、化痰药、活血化瘀药等。药物关联组合支持度较高的有贝母-夏枯草、玄参-牡蛎、夏枯草-海藻等。李卫卫报道了西药联合内消瘰疬丸治疗颈部淋巴结结核61例临床观察,对两组T细胞亚群、不良反应以及临床疗效进行比较。结果两组治疗后T细胞亚群相关指标均较治疗前有明显改善,并且观察组CD3+和CD4+水平高于对照组,CD8+水平低于对照组。米晓燕报道观察内消瘰疬丸和健脾润肺丸联合药物化学治疗颈淋巴结结核的疗效。将颈部淋巴结结核患者分为两组,两组均采用3HRZE/9HRE方案治疗,同时治疗组加服内消瘰疬丸和健脾润肺丸,对比观察两组治疗效果.结果治疗3,6个月末,治疗组胃肠道反应,肝功能异常发生情况较对照组低,治疗组机体一般状况改善较对照组好,在治疗1个月末,对照组和治疗组淋巴结吸收和伤口愈合总有效率分别为59.2%,72.9%;治疗3,6月末治疗组淋巴结吸收和伤口愈合总有效率均高于对照组。
CN107050229B公开了一种治疗痈疽瘰疬的药物组合物及其制备方法,由如下重量计的:制白附子2~8g、制天南星2~10g、垂盆草12~30g、牡丹皮4~15g、玄参6~12g、鱼腥草2~12g、射干2~12g、山豆根2~8g、黄芪8~30g、灵芝4~15g、马鞭草4~12g、草河车4~10g和仙人掌12~30g作原料药制成。其临床诊断、治疗标准,主症:淋巴结肿大,疼痛,发红,皮肤脓肿、囊肿,栗状样脓头,红肿胀痛,溃破后呈莲蓬状、蜂窝状,全身性化脓性感染。次症:脂肪瘤、粉刺瘤,淋巴结无痛性肿大,无黏连,局部红、肿、热、痛。CN1233495A公开了一种消瘰疬冲剂,由党参、白术、当归、白芍、制半夏、陈皮、白花蛇舌草、蛇莓、夏枯草、海藻、牛黄、黄药子等为主的中的中药组成的处方,其临床治疗:患者1992年3月右颈中出现一肿块约3×5cm,经某医院活检后诊为“淋巴结核”,经抗结核治疗3个月未见明显改善,肿块逐渐增大,皮色转暗,疼痛,盗汗,口干,而来求治。[检查]右颈3×5cm,2×3cm肿块2个,推之不动,局部皮肤暗红,微热,中软,按之应指;舌红苔少,脉弱数。按上治法继续治疗2个月后,创口收敛,精神好,舌淡红苔白,脉象正常。复查血常规,血沉正常。随访3年,未见复发。
“瘰疬”在中医中,除了局部肿大溃脓胀痛之外,还存在口干、乏力、气短、盗汗、口苦等其它症状,然而目前的治疗更多采取软坚散结、清热化痰、活血化瘀的治法,而且临床治疗更关注淋巴结的消肿散结、胀痛以及血液循环、免疫等方面的治疗,对口干、乏力、气短、盗汗、口苦等其它临床问题并未纳入整体考虑,缺少整体的治疗方案,其临床治疗效果仍不能满足临床的需求。
发明内容
本发明目的在于克服现有技术的不足,针对颈部脓肿型淋巴结结核的病机,以“益气养阴,和血解毒”为核心治则,扶正与祛邪并重,提供一种疗效好、疗程短、安全性高的治疗颈部脓肿型淋巴结结核的中药组合物,能有效治疗淋巴结结核,并改善口干、乏力、气短、盗汗、口苦等症。
本发明是通过以下技术方案实现的:
一种治疗颈部脓肿型淋巴结结核的中药组合物,所述中药组合物由下列重量份配比的中药原料制备而成:
黄芪10-100重量份,当归10-50重量份,炒白术10-40重量份,沙参10-30重量份,皂角刺10-30重量份,金银花10-30重量份,煅牡蛎10-50重量份,川芎10-25重量份。
本发明中各味中药原料的主要功效及药理作用为:
黄芪:性味甘,温。归肺、脾经。功能主治:补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。含黄酮类成分毛蕊异黄酮、3-羟基-9,10-二甲氧基紫檀烷,还含黄芪皂甙Ⅰ、Ⅴ、Ⅲ。
当归性味甘、辛,温,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。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。当归挥发油主含藁本内酯(ligustilide),占45%,其次正丁烯夫内酯。根的水溶性部分含阿魏酸(ferulicacid)、丁二酸(succinicacid)、菸酸(nicotinicacid)、尿嘧啶(uracil)、腺嘌呤(adenine)、东莨菪素(scopoletin)、伞形酮(umbelliferone)、香荚兰酸(vanillicacid)及胆碱。药理研究表明当归煎剂、水提物及其有效成分阿魏酸钠均能增加小鼠心肌摄取86Rb的能力,使心肌营养性血流量分别增加36.3%、40.6%和46%,说明当归能使心肌毛细血管开放增多。当归和阿魏酸抑制血小板聚集系通过抑制血小板释放反应。在某些药理活性方面,当归及其成分阿魏酸和阿斯匹林有相似之处。阿斯匹林的抗炎作用和抑制血小板聚集有关。当归及其阿魏酸钠有明显的抗血栓作用。大鼠实验表明,当归可使血栓干重量显着减少,血栓增长速度较对照组下降。
白术性味苦、甘,温,归脾、胃经。功能主治: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。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安。川芎:性味辛、温,是活血祛瘀的常用药物,具有活血行气,祛风止痛的功效。临床常用于血瘀气滞所导致的痛经、经闭以及产后血瘀腹痛、跌打损伤等。
沙参性味甘,凉。功能主治清热养阴,润肺止咳。主治气管炎,百日咳,肺热咳嗽,咯痰黄稠。具有祛痰、抗菌作用。
金银花清热解毒,凉散风热。用于外感风热或温病初起。银花甘寒,既清气分热,又能清血分热,且在清热之中又有轻微宣散之功,所以能治外感风热或温病初起的表症未解、里热又盛的病症。
皂角刺归肝、胃经。功能主治消肿托毒,排脓,杀虫。用于痈疽初起或脓成不溃;外治疥癣麻风。
牡蛎性味咸,微寒。归经归肝、胆、肾经。功能主治重镇安神,潜阳补阴,软坚散结。用于惊悸失眠,眩晕耳鸣,瘰疬痰核,症瘕痞块。
川芎主要含有川芎嗪、阿魏酸、川芎素、生物碱、酚性物质等,可改善微循环、降低血管阻力,显著增加脑及肢体血流量。
方中重用黄芪益气,当归补血,配以养阴益气的沙参,共奏益气养阴和血的功效,共为君药;煅牡蛎软坚散结,白术健脾益胃,助黄芪益气托毒,金银花清热解毒,为疮家圣药,既可消肿又可透脓,共为臣药;皂角刺消肿托毒,《雷公炮制药性解》中提到“未溃者能发散,其已溃者能排脓,药直达脓处成功。”川芎行气活血,为血中之气药,又能上行头目,共为使药。本方有益气养阴和血,托毒透脓的作用。
本发明主要是通过益气养阴、和血解毒来达到治疗颈部脓肿型淋巴结结核的目的,所以对辨证属气阴两虚证的淋巴结核效果最佳,主要表现为颈部包块红肿,口干,气短,乏力,盗汗,手足心热。
所述治疗颈部脓肿型淋巴结结核的中药组合物进一步优选,其由下列重量份配比的中药原料制备而成:黄芪15-50重量份,当归10-30重量份,炒白术10-25重量份,沙参10-25重量份,皂角刺10-25重量份,金银花10-25重量份,煅牡蛎15-35重量份,川芎10-20重量份。
黄芪15-30重量份,当归10-20重量份,炒白术10-30重量份,沙参10-20重量份,皂角刺10-20重量份,金银花10-20重量份,煅牡蛎10-20重量份,川芎10-20重量份。
黄芪20重量份,当归20重量份,炒白术25重量份,沙参15重量份,皂角刺15重量份,金银花15重量份,煅牡蛎20重量份,川芎15重量份。
其中黄芪、沙参和川芎重量比优选(1.5-4):(1-2):(1-2),更优选2:1.5:1.5。
本发明进一步提供一种上述中药组合物在制备治疗淋巴结结核药物中的用途,优选用于制备治疗颈部脓肿型淋巴结结核药物中的用途,或优选用于制备治疗气阴两虚证的淋巴结结核药物中的用途。
本发明的中药组合物还用于制备治疗淋巴结结核合并口干,气短,乏力,盗汗,手足心热症药物中的用途。
本发明的中药方剂为原生中药材,可根据需要在现代工艺下制成汤剂、丸剂、片剂、散剂、胶囊颗粒等,但以汤剂效果最佳。
本发明还提供上述中药组合物的制备方法,除牡蛎,将其它原料药粉碎后过筛,加水和/或乙醇溶液提取,提取液浓缩干燥后,加辅料制备成剂型。
所述乙醇溶液为30%-80%的乙醇溶液,优选50%,60%、70%乙醇。
优选,除牡蛎,将其它原料药粉碎成30-40目颗粒,加水浸泡0.5-1小时后,加热煎煮两次,每次1-2小时,每次加水倍量为8-12倍。
或优选,将各原料药粉碎成30-40目颗粒,加水浸泡0.5-1小时后,加热煎煮一次,过滤,收集滤液,药渣再加入10-12倍量的50-80%乙醇加热回流提取1-2小时,过滤,收集滤液,将第一次和第二次的滤液合并浓缩,干燥后加入辅料制备成型。
或优选,将牡蛎打碎加水先煎煮0.5小时,然后再加入金银花、川芎继续煎煮2次,每次1小时,合并滤液,浓缩干燥得第一提取物;将黄芪、当归、白术、沙参、皂角刺加10-12倍量的50-80%乙醇加热回流提取1-2小时,提取两次,合并滤液,浓缩干燥得第二提取物;混合第一、二提取物,加入辅料制备成型。
本发明的中药方剂使用剂量及方法为:本发明的中药为一日剂量,每天一剂煎汤内服,煎三汁分两次服下。28天为一个疗程,一般用药3-6个疗程。患者在使用本中药期间应注意禁食辛辣,肝肾损害者慎用。
附图说明:
图1病例1治疗前后比较图
图2病例2治疗前后比较图
图3病例3治疗前后比较图
具体实施方式
下面对本发明的实施例作详细说明,以下实施例在以本发明技术方案为前提下进行实施,给出了详细的实施方式和具体的操作过程,但本发明的保护范围不限于下述的实施例。
实施例1:
黄芪20克,当归20克,炒白术25克,沙参15克,皂角刺15克,金银花15克,煅牡蛎20克,川芎15克。
(1)煅牡蛎打碎加水先煎半小时,将其它原料药粉碎过筛至40目,然后加水煎煮两次,第一次加原料药总重量的8倍量水,武火煎煮沸腾10分钟,再用文火煎煮40分钟,过滤,得第一次煎煮液和药渣;
(2)药渣加原料药总重量的10倍量水,武火煎煮至沸腾,再用文火煎煮1小时,过滤,得第二次煎煮液;
(3)合并两次煎煮液,武火煮沸,再用文火煎煮10分钟即得汤剂。
实施例2:
黄芪60克,当归30克,炒白术25克,沙参20克,皂角刺20克,金银花10克,煅牡蛎40克,川芎20克。
除牡蛎,将其它原料药粉碎成30-40目颗粒,加水浸泡0.5小时后,加热煎煮1.5小时,过滤,收集滤液,药渣再加入12倍量的70%乙醇加热回流提取1小时,过滤,收集滤液,将第一次和第二次的滤液合并浓缩,干燥后粉碎,加入玉米淀粉、蔗糖制成颗粒。
实施例3:
黄芪80克,当归40克,炒白术20克,沙参20克,皂角刺15克,金银花15克,煅牡蛎30克,川芎20克。
将牡蛎打碎加水先煎煮0.5小时,然后再加入金银花、川芎继续煎煮2次,每次1小时,合并滤液,浓缩干燥得第一提取物;将黄芪、当归、白术、沙参、皂角刺加10倍量的60%乙醇加热回流提取2小时,提取两次,合并滤液,浓缩干燥得第二提取物;混合第一、二提取物,加入玉米淀粉、糊精、微晶纤维素制成颗粒,再加入硬脂酸镁压制成片。
实施例4:
黄芪20克,当归20克,炒白术20克,沙参10克,皂角刺15克,金银花20克,煅牡蛎30克,川芎20克。
将牡蛎打碎加水先煎煮0.5小时,然后再加入金银花、川芎继续煎煮2次,每次2小时,合并滤液,浓缩干燥得第一提取物;将黄芪、当归、白术、沙参、皂角刺加8倍量的70%乙醇加热回流提取2小时,提取两次,合并滤液,浓缩干燥得第二提取物;混合第一、二提取物,加入预胶淀粉、蔗糖、微晶纤维素制成颗粒,再加入硬脂酸镁压制成片。
实施例5:
黄芪30克,当归25克,炒白术20克,沙参15克,皂角刺15克,金银花20克,煅牡蛎30克,川芎10克。
除牡蛎,将其它原料药粉碎成40目颗粒,加水浸泡0.5小时后,加热煎煮2小时,过滤,收集滤液,药渣再加入10倍量的80%乙醇加热回流提取2小时,过滤,收集滤液,将第一次和第二次的滤液合并浓缩,干燥后粉碎,加入微晶纤维素、蔗糖制成颗粒。
临床疗效观察:
对2020年10月至2021年10月首都医科大学附属北京胸科医院的颈部脓肿型淋巴结结核患者30例进行临床观察。
观察患者治疗6周时颈部包块改善率,包块的大小依据超声检查测定,若包块减小≥50%则判定为改善。定义:改善率=包块减小≥50%的人数/总人数×100%。同时观察治疗24周时的疗效。
显效:大部分症状、体征明显改善,或部分消失,证候积分减少≥70%;
有效:临床症状、体征均有好转,证候积分减少≥30%;
无效:临床症状、体征均无改善,甚至加重,证候积分减少<30%。
以局部胀痛、口干、乏力、气短、盗汗、口苦为观察症状进行中医证候评分。
表1证候量化评分表
表2临床治疗观察结果
结果分析:本中药方剂治疗颈部脓肿型淋巴结结核效果显著。
典型病例:
病例1:张某,女,30岁,因“颈部包块3月”就诊。患者2020年10月因工作劳累出现左侧颈部包块,就诊于北京胸科医院结核外科,行颈部淋巴结穿刺活检,病理报告提示可见肉芽肿性坏死,分子检测可见TB-DNA阳性,诊断为“颈部淋巴结核”,予抗结核治疗,1月后颈部包块红肿热痛,就诊于北京胸科医院中医科。刻下症:乏力、口干,便秘,盗汗,心烦,舌红苔白,脉细数。按上述证候量化评分表1,其评分结果为局部胀痛3分、乏力3分、气短3分、盗汗3分、口干2分、口苦2分,共计16分。辨证为气阴两虚。以益气养阴和血为主。予本方剂煎汤内服,每日1剂,治疗5日颈部包块脓出,包块缩小,治疗15日乏力、口干、便秘、盗汗症状消失,继续治疗12周颈部包块基本消失,创面愈合。治疗后证候评价打分如下:局部胀痛0分、乏力0分、气短0分、盗汗0分、口干0分、口苦1分,共计1分,证候积分减少93.7%,大于70%。治疗过程见附图1。
病例2:患者代某,女,31岁。因“颈部包块2月”就诊。2020年11月患者左侧颈部出现多个肿大淋巴结,未在意,2月后包块明显变大,左侧颈部局部红肿,疼痛明显,就诊于我院结核外科,穿刺活检,病理提示肉芽肿性坏死,分子检测TB-DNA阳性,诊断为“颈部淋巴结结核”,予抗结核治疗,患者就诊于中医科门诊,刻下症:左侧颈部红肿疼痛,包块质硬,按压痛,乏力,口干口苦,寐差,二便调,舌淡红苔白,脉弦细。按上述证候量化评分表1,其评分结果为局部胀痛3分、乏力3分、气短3分、盗汗2分、口干2分、口苦1分,共计14分。辨证为气阴不足,以益气养阴和血为主,予本中药方剂煎汤内服,每日1剂,治疗8天后包块脓出,包块缩小,治疗80天后包块消失,创面愈合。治疗后证候评价打分如下:局部胀痛0分、乏力0分、气短1分、盗汗1分、口干1分、口苦0分,共计3分,证候积分减少78.6%,大于70%。治疗过程见附图2。
病例3:患者彭某,男,20岁。因“颈部包块6个月”就诊。患者2020年10月右侧颈部出现包块,当地医院就诊,PPD强阳性,颈部穿刺活检病理提示肉芽肿性坏死,分子检测发现TB-DNA阳性,结合既往肺结核病史2年,诊断为“颈部淋巴结结核”,予抗结核治疗。但颈部包块逐渐增大,遂就诊于北京胸科医院中医科,刻下症:右侧颈部胀痛,气短,乏力,口干,纳差,寐差,舌红苔薄,舌中裂纹,脉弦细。按上述证候量化评分表1,其评分结果为局部胀痛3分、乏力3分、气短3分、盗汗2分、口干3分、口苦2分,共计16分。辨证为气阴两虚,以益气养阴和血为主,予本中药方剂煎汤内服,治疗10天后包块脓出,包块缩小,治疗20天坏死皮肤全部脱落,治疗60天后创面明显缩小,治疗150天后包块消失,创面基本愈合。治疗后证候评价打分如下:局部胀痛0分、乏力0分、气短1分、盗汗1分、口干1分、口苦0分,共计3分,证候积分减少81.3%,大于70%。治疗过程见附图3。
Claims (5)
1.一种治疗颈部脓肿型淋巴结结核的中药组合物,其特征在于,黄芪15-30重量份,当归10-20重量份,炒白术10-30重量份,沙参10-20重量份,皂角刺10-20重量份,金银花10-20重量份,煅牡蛎10-20重量份,川芎10-20重量份。
2.根据权利要求1所述的中药组合物,其特征在于,黄芪20重量份,当归20重量份,炒白术25重量份,沙参15重量份,皂角刺15重量份,金银花15重量份,煅牡蛎20重量份,川芎15重量份。
3.根据权利要求1或2所述的中药组合物在制备治疗颈部脓肿型淋巴结结核药物中的用途。
4.根据权利要求1或2所述的中药组合物在制备治疗淋巴结结核合并口干,气短,乏力,盗汗,手足心热症药物中的用途。
5.根据权利要求1或2所述中药组合物的制备方法,其特征在于,除牡蛎,将其它原料药粉碎后过筛,加水和/或乙醇溶液提取,提取液浓缩干燥后,加辅料制备成剂型。
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