CN115154550B - 一种治疗溃疡型淋巴结结核的外用中药组合物 - Google Patents
一种治疗溃疡型淋巴结结核的外用中药组合物 Download PDFInfo
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Abstract
本发明提供一种治疗溃疡型淋巴结结核的外用中药组合物,由下列重量份配比的重要原料制备而成:白芨10g,白芷10g,当归10g,乳香5g,没药5g。该中药组合物能有效治疗淋巴结结核红肿破溃、皮肤溃烂等。
Description
技术领域
本发明涉及一种中药,尤其涉及的是一种治疗溃疡型淋巴结结核的外用中药组合物
背景技术
淋巴结核为最常见的肺外结核,淋巴结核一旦形成脓肿,或脓肿破裂,形成瘘管或溃疡,创口迁延、经久不愈,继发感染的几率高,严重影响患者的生活及生存质量。淋巴结结核在中医属于瘰疬的范畴,瘰疬发病通常认为有内外之因。外因多为直接感染痨虫,或感受风火毒邪,内因多为肝气郁结,脾失健运,痰湿内生,气滞痰凝,阻于经脉,结于颈项,而成瘰疬。肝气郁结,日久化火;脾失健运,聚湿生痰,湿浊化热,热盛肉腐而成脓,破溃成疮。亦可肺肾阴亏,虚火内炽,肺津亏虚,能输布无力,津凝为痰,血滞为瘀,痰瘀阻滞,痰火凝结颈项而至;或继发于肺痨。外因主要责于素体虚弱,情志不畅,感受风火毒邪,痰火结于颈项而至;或直接感染痨虫所致。瘰疬术后久不敛口,主要责于气阴两虚,湿邪留恋。根据其临床表现及病程进展,分为结节型、浸润型、脓肿型、溃疡型。其中溃疡型淋巴结结核属于疾病后期,临床表现为病变淋巴结融合成团,化脓破溃,流出豆渣样或稀米汤样脓液,创周皮色暗红,创面肉芽水肿苍白,多有潜行性空腔,或伴有窦道形成,缠绵难愈,属临床难治痼疾。
高敏行等报道溃疡型淋巴结结核病机主要为邪毒脓腐郁积,气血化生不足。根据此创面特点,提出泄毒生新外治法,运用具有解毒祛腐、敛疮生肌之效的中药,促进邪毒泄除、窦漏脱化、脓毒排出;通利血脉,使溃疡或窦道处气血津液流通,敛疮生肌收口,泄毒祛腐和生肌化新同时进行,毒邪得泄,气机通畅,脏腑功能协调,气血得以化生,形体得之濡养则可生肌收口。采用复方五凤草液,其中五凤草(即泽漆)行水杀虫、祛腐解毒;白及敛疮消肿、止血生肌;猫爪草拔脓解毒、活血消肿。然而该方中泽漆为有毒药物,并主要采用解毒祛邪药物泽漆和猫爪草,同时该方也是针对气血生化不足,即气血不足者,但在《得配本草》中记载,对于气血虚者禁用泽漆。
同时传统方剂《外科全生集》中,记载了阳和解凝膏用于治疗瘰疬,其组成包括:鲜牛蒡子、鲜白凤仙梗、川附、桂枝、大黄、当归、肉桂、草乌、地龙、僵蚕、赤芍、白芷、白蔹、白芨、乳香、没药、续断、防风、荆芥、五灵脂、木香、香橼、陈皮。加入菜油,熬枯去渣,加入黄丹制成贴膏剂。对于肿块坚硬不消者,如醒消丸,采用乳香、没药各、麝香、雄黄.共碾制成丸剂。
CN105343215A公开了一种用于治疗结核的中药复方外用制剂及其制备方法,包括以下原料:巴豆、猫爪草、大枣、朱砂、夏枯草、大血藤和连翘。该中药复方外用制剂用于治疗淋巴结核、淋巴肿大、乳腺结核、骨结核、肺结核及乳腺炎、乳腺增生和各种淋巴性炎症。CN101647934A公开了一种外用拔毒生肌膏,主要由下述重量份的原料:轻粉、绿青、血竭、儿茶、银朱、蜂蜡、重楼、紫草、败酱草、白芷、斑蝥、松香、麻油组成,制备时,先将紫草、败酱草、斑蝥、白芷、重楼加入麻油内加热熬煎,去渣,加入蜂蜡、松香溶化后,再将轻粉、银朱、儿茶、绿青、血竭研成的粉末加入其中,搅匀即得;具有破瘀软坚,消肿止痛,去腐生肌之功效,对痈疽发背,已溃未溃的疔疮肿毒,以及丹毒引起的淋巴结炎等具有较好疗效。
因而目前中药方剂的组方原料过大,或通常需要大毒药物配合应用,或不能有效地针对溃疡型疾病气血虚的特点,增大了临床应用的安全风险和治疗的效果。
发明内容
本发明目的在于克服现有技术的不足,针对溃疡型淋巴结核,提供一种毒副作用小,治疗效果好的外用中药。
本发明是通过以下技术方案实现的:
一种治疗溃疡型淋巴结核的外用中药组合物,由下列重量份配比的中药原料制备而成:白芨5-50重量份,白芷5-50重量份,当归5-50重量份,乳香1-20重量份,没药1-20重量份。
优选所述中药组合物由下列中药份配比的中药原料制备而成:白芨5-25重量份,白芷5-25重量份,当归5-25重量份,乳香1-15重量份,没药1-15重量份。
优选所述中药组合物由下列中药份配比的中药原料制备而成:白芨5-20重量份,白芷5-15重量份,当归5-15重量份,乳香5-10重量份,没药5-10重量份。
最优选由下列中药份配比的中药原料制备而成:白芨10重量份,白芷10重量份,当归10重量份,乳香5重量份,没药5重量份。
本发明还提供一种外用中药制剂,其包含上述的中药组合物和辅料。
所述制剂选自贴剂、膏剂、乳剂、溶液剂、散剂。
本发明还提供外用中药组合物的制备方法,将各原料药粉碎成细粉;或者将白芨、白芷和当归加水提取,制备水提物,乳香和没药用含醇溶液提取,制备醇提取,然后合并水提物和醇提物。
同时本发明还提供该外用中药组合物在制备治疗溃疡型淋巴结结核药物中的应用。
其中白芨苦甘,凉,具有补肺,止血,消肿,生肌,敛疮。治肺伤咳血,衄血,金疮出血,痈疽肿毒,溃疡疼痛,汤火灼伤,手足皲裂。同时《本草经疏》记载“痈疽已溃,不宜同苦寒药服”,对于溃疡型淋巴结结核病,毒邪与气血虚弱不足并存,因而,该病极大地限制了白芨与其它苦寒祛毒药物相配伍。
白芷味辛,性温,具有祛风除湿;通窍止痛;消肿排脓。主感冒头痛;眉棱骨痛;牙痛;鼻塞;鼻渊;湿胜久泻;妇女白带;痈疽疮疡;毒蛇咬伤。
当归补血和血,调经止痛,润燥滑肠。治月经不调,经闭腹痛,症瘕结聚,崩漏;血虚头痛,眩晕,痿痹;肠燥便难,赤痢后重;痈疽疮窃,跌扑损伤。《日华子本草》记载″治一切风,一切血,补一切劳,破恶血,养新血及主癥癖。″《汤液本草》:当归,入手少阴,以其心主血也;入足太阴,以其脾裹血也;入足厥阴,以其肝藏血也。头能破血,身能养血,尾能行血,用者不分,不如不使。若全用,在参、芪皆能补血;在牵牛、大黄,皆能破血,佐使定分,用者当知。从桂、附、茱萸则热;从大黄、芒硝则寒。
乳香辛苦,温,具有调气活血,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。没药散血去瘀,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,《医学衷中参西录》:″乳香、没药,二药并用,为宣通脏腑、流通经络之要药,故凡心胃胁腹肢体关节诸疼痛皆能治之。又善治女子行经腹疼,产后瘀血作痛,月事不以时下。其通气活血之力,又善治风寒湿痹,周身麻木,四肢不遂及一切疮疡肿疼,或其疮硬不疼。外用为粉以敷疮疡,能解毒,消肿、生肌、止疼,虽为开通之品,不至耗伤气血,诚良药也。
针对溃疡型淋巴结核,其为疮疡为实热之症,脓而腥臭为气血不和,湿邪所致。本发明以白芨和白芷为君药,白芨敛腐生肌,白芷燥湿消肿排脓,具有较强的收敛作用,还可参与机体组织修复,迅速排脓、止痛、生肌,促进炎症的吸收和消散,保持创面干燥,促进创面愈合,两者共为君药。当归为臣药,当归补血活血,对于气血虚者,适于合理补益气血,而不助毒邪,对溃疡、溃后脓血等具有良好的治疗效果。乳香、没药为佐药,乳香能活血化瘀、行气止痛、消肿生肌,血竭则止痛、生肌敛疮作用;没药具有活血止痛、消肿生肌功效,可加速创口愈合,两药共为佐药,协同治疗。本发明外用中药组合物对于气阴两虚型溃疡型淋巴结结核具有显著疗效,尤其适用于气阴不足,毒邪上攻型的溃疡型淋巴结结核。
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
图4病例4治疗前后比较图
图5病例5治疗前后比较图
图6病例6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:
治疗溃疡型淋巴结核的外用制剂
处方:白芨10g,白芷10g,当归10g,乳香5g,没药5g。
制备方法:将白芨、白芷、当归混合后,用粉碎机粉碎成粗粉,然后将乳香、没药加入至上述粗粉中,继续粉碎成80-100目的细粉,最后将上述细粉共同混合均匀,制成散剂。
实施例2
治疗溃疡型淋巴结核的外用制剂
处方:白芨12g,白芷15g,当归10g,乳香5g,没药5g。
制备方法:将白芨、白芷、当归、乳香和没药粉碎成粗粉,加入10倍量的芝麻油浸泡24小时,煎煮1小时,至药呈枯黄后,过滤,收集滤液,向所述滤液中加入白蜡混合,制成外用制剂。
实施例3
治疗溃疡型淋巴结核的外用制剂
处方:白芨8g,白芷7g,当归16g,乳香9g,没药5g。
制备方法:将白芨、白芷、当归、乳香和没药粉碎成粗粉,加入12倍量的水煎煮2小时,取滤液;滤渣继续加10倍量水煎煮1.5小时,收集合并滤液,即得。应用时,用无菌棉片,浸湿该滤液,用于外敷。
实施例3
治疗溃疡型淋巴结核的外用制剂
处方:白芨16g,白芷7g,当归16g,乳香6g,没药5g。
制备方法:将乳香和没药加10倍量的50%乙醇回流提取1.5小时,取滤液,再将滤渣用50%乙醇回流提取1小时,取滤液,合并醇提液,然后将醇提液挥至无醇味;将白芨、白芷、当归混合后,加入10倍量的水煎煮1.5小时,取滤液;滤渣继续加8倍量水煎煮1小时,收集合并水提液,然后将上述两部分提取液合并。应用时,用无菌棉片,浸湿该滤液,用于外敷。
实施例4
治疗溃疡型淋巴结核的外用制剂
处方:白芨10g,白芷7g,当归16g,乳香15g,没药5g。
制备方法:将乳香和没药加12倍量的55%乙醇回流提取1.5小时,取滤液,再将滤渣用55%乙醇回流提取1小时,取滤液,合并醇提液,然后将醇提液挥至无醇味;将白芨、白芷、当归混合后,加入10倍量的水煎煮1.5小时,取滤液;滤渣继续加8倍量水煎煮1小时,收集合并水提液,然后将上述两部分提取液合并。应用时,用无菌棉片,浸湿该滤液,用于外敷。
实验例1
临床疗效观察:
对2020年至2022年首都医科大学附属北京胸科医院的颈部淋巴结结核患者20例进行临床观察。
1.诊断标准:
淋巴结核诊断标准:(1)结核病中毒症状。(2)浅表或体内淋巴结肿大。(3)淋巴结穿刺脓液中找到抗酸杆菌。(4)淋巴结组织病理学检查符合结核病病理改变。(5)对暂时不能明确诊断的,诊断性抗结核治疗观察。(2021年11月《中国结核病预防控制工作指南》)
中医辨证标准:中医核心病机为气阴两虚证。
参考《中药新药临床研究指导原则(试行)》结合临床实际,制定以下标准:
气阴不足,毒邪上攻证型:
主症:①倦怠乏力;②少气懒言;③口干口苦;④五心烦热;⑤潮热盗汗
次症:①食少纳差;②头晕耳鸣;③舌红或黄苔;④脉弦细;⑤心烦易怒
具备主症3项、次症3项,即可诊断为上述证候。
2.纳入标准:
(1)年龄18~70岁,男女不限;
(2)符合诊断标准的颈部淋巴结结核;
(3)中医辨证属气阴两虚、毒邪上攻者;
(4)知情同意并签署知情同意书。
3.排除标准:
(1)合并严重心、肺、肝、肾和血液系统等严重原发性疾病;
(2)对干预中药和抗结核药物(HRZE)不能耐受或任一耐药;;
(3)精神病患者;
(4)妊娠及哺乳期患者。
主要观察指标:
用药治疗12周时,观察以下指标。
定义:有效率=(显效人数+好转人数)/总人数×100%。
显效:溃疡面好转、包块消退、伤口愈合≥70%;
好转:溃疡面好转、包块消退、伤口愈合≥30%;
无效:溃疡面未好转、包块未消退、伤口未愈合,甚至加重。
表1治疗结果
结果表明:在初步临床观察中,发现本发明中药方剂对于气阴两虚型的溃疡型淋巴结核治疗效果显著,能显著促进创面愈合,以及包块消退。
典型病例:
病例1:孙某,女,32岁,因“颈部包块6月,加重3月”于2021年5月31日就诊。患者2020年11月出现颈部包块,初起皮色不变,予抗感染治疗无效,就诊于当地医院穿刺,脓培养提示结核杆菌阳性,予抗结核治疗,包块无明显好转,伤口处结痂严重,遂就诊于北京胸科医院中医科。刻下症:口干、乏力、纳寐可,平素易腹泻,舌暗苔白,脉弦细。每日予实施例1药物外敷8小时,1月后伤口处干净,伤口面缩小,12周后创面愈合,红肿包块明显变小。治疗过程附图1。
病例2:许某,女,31岁,因“颈部包块3月余”于2022年1月就诊。患者2021年5月因发热,就诊于当地医院发热门诊,胸部CT提示肺结核,予抗结核治疗。2021年10月右颈部出现一红肿包块,继而出现红肿溃烂,就诊于北京胸科医院结核科,脓培养提示结核杆菌阳性。刻下症:口干、乏力、胃痛,局部肿胀感明显,颈部活动受限,舌红苔白,脉弱。每日予实施例1药物外敷8小时,连续治疗1月后破溃面明显好转,11周后创面愈合,红肿包块明显消退。治疗过程见附图2。
病例3:吴某,女,37岁,因“左侧颈部包块半年”于2021年9月就诊。患者2021年4月出现左侧颈部包块,就诊于306医院,穿刺后于北京胸科医院病理会诊,分子检测结果提示TB-DNA阳性,予抗结核治疗4月后效果不佳,包块变大,9月3日外科手术治疗,术后半月切口出现干酪样坏死物,切口裂开,遂就诊于中医科治疗。刻下症:乏力、寐差,二便调,舌红苔白,脉濡弱。每日予实施例1药物外敷8小时,1周后伤口缩小,8周后创面愈合,红肿包块明显变小。治疗过程见附图3。
病例4:姚某,男,24岁,因“左侧颈部包块4月”于2022年2月就诊。患者2021年10月出现颈部包块,取脓培养结果提示结核杆菌阳性。予抗结核治疗,但颈部包块继续增大、破溃。刻下症:局部肿胀,乏力、怕冷,舌红苔白,脉弱。每日予实施例1药物外敷8小时,6周后包块消退,伤口愈合。治疗过程见附图4。
病例5:苗某,女,51岁,因“颈部淋巴结肿大5年,加重2月”于2021年10月就诊。患者5年来颈部淋巴结反复肿大,无其他不适,未在意。近2月出现颈部淋巴结红肿,伴有局部明显疼痛感,影响进食睡眠,就诊于当地医院,穿刺活检,并于北京胸科医院结核科和病理科会诊,分子检测病理结果提示分枝杆菌阳性(胞内型),予相应抗非结核分支杆菌治疗。现因包块红肿化脓、局部疼痛明显就诊于中医科治疗。刻下症:颈部红肿疼痛,波及面部、右侧头部疼痛,纳差,口干,乏力,便干,舌暗苔白厚质干,脉弱。每日予实施例2药物外敷8小时,12周后脓肿包块消退,伤口愈合。治疗过程见附图5。
病例6:李某,女,31岁,因“颈部包块3月”于2021年11月就诊。患者2021年8月出现颈部包块,10月包块明显增大,就诊于北京胸科医院结核科门诊,穿刺活检病理结果提示Xpert阳性,无突变。予抗结核治疗。刻下症:乏力、口干、盗汗,纳差,恶心,舌淡苔白,脉弦细。每日予实施例3药物外敷8小时,10周后包块消退,伤口愈合。治疗过程见附图6。
Claims (9)
1.一种治疗溃疡型淋巴结结核的外用中药组合物,其特征在于所述中药组合物由下列重量份配比的中药原料制备而成:白芨5-50重量份,白芷5-50重量份,当归5-50重量份,乳香1-20重量份,没药1-20重量份。
2.根据权利要求1所述的外用中药组合物,其特征在于,所述中药组合物由下列重量份配比的中药原料制备而成:白芨5-25重量份,白芷5-25重量份,当归5-25重量份,乳香1-15重量份,没药1-15重量份。
3.根据权利要求1所述的外用中药组合物,其特征在于,所述中药组合物由下列重量份配比的中药原料制备而成:白芨5-20重量份,白芷5-15重量份,当归5-15重量份,乳香5-10重量份,没药5-10重量份。
4.根据权利要求1所述的外用中药组合物,其特征在于,所述中药组合物由下列重量份配比的中药原料制备而成:白芨10重量份,白芷10重量份,当归10重量份,乳香5重量份,没药5重量份。
5.一种治疗溃疡型淋巴结结核的外用中药制剂,其特征在于,其包含权利要求1-4任意一项所述的中药组合物和辅料。
6.根据权利要求5所述的外用中药制剂,其特征在于,所述制剂选自贴剂、膏剂、乳剂、溶液剂或散剂。
7.根据权利要求1-4任意一项所述的外用中药组合物的制备方法,其特征在于,将各原料药粉碎成细粉;或者将白芨、白芷和当归加水提取,制备水提物,乳香和没药用含醇溶液提取,制备醇提取物,然后合并水提物和醇提物。
8.根据权利要求1-4任意一项所述的外用中药组合物在制备治疗溃疡型淋巴结结核药物中的应用。
9.根据权利要求1-4任意一项所述的外用中药组合物在制备治疗气阴两虚型的溃疡型淋巴结结核药物中的应用。
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