CN115607611B - 一种用于外治未溃浅表淋巴结结核的中药组合物 - Google Patents
一种用于外治未溃浅表淋巴结结核的中药组合物 Download PDFInfo
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Abstract
本发明提供一种针对初期未溃患者提供一种外用中药组合物制剂,其中药组合物由味的玉露膏组合而成,包括芙蓉叶20~35份,生半夏20~35份,乳香10~18份,没药10‑18份,冰片5~8份,诸药合用发挥清热解毒,促进肿块吸收缩小,减少淋巴结坏死液化、形成溃疡和窦道的发生几率,从而增加疗效,减少患者治疗创伤和痛苦。
Description
技术领域
本发明涉及中医药领域,具体涉及用于外治浅表淋巴结结核的中药配方及其制备方法。
背景技术
结核病目前仍是世界上重要的感染性疾病。结核分枝杆菌可以在人体许多器官、组织内播散和生存。肺外结核是指发生于肺部以外脏器的结核病,约占全部结核病的20%,是结核病的重要组成部分,其中淋巴结结核是由结核分枝杆菌经淋巴循环、血液循环或邻近病灶侵入淋巴结,引起淋巴结的慢性炎症;根据病程进展及临床表现等,分为结节型、浸润型、脓肿型、溃疡型4型,居肺外结核病之首,是淋巴系统疾病中重要的病因。目前国内外对淋巴结结核的临床研究较少,且相对于肺结核,肺外结核症状往往不典型,容易误诊误治。
淋巴结结核占淋巴系统疾病的80-90%,也是最常见的肺外结核,浅表淋巴结结核发生的部位以颈部最多见,淋巴结核规范治疗疗程长,复发率较高,治疗后肿大淋巴结往往不能够完全恢复如初,而且即使在规范抗结核化疗的情况下,仍有20%患者发生肿大淋巴结周围炎、干酪样坏死、液化形成脓肿,并最终溃破形成多种形式的难以愈合得伤口和窦道。其溃破后脓液、瘘管的分泌物具有较强的传染性,而临床此类患者一般不采取隔离措施,有可能成为一种结核病重要的传染源。
目前浅表淋巴结结核治疗模式中,主要是以抗结核药物化疗结合手术,根据结核耐药情况,采用敏感和耐药方案进行抗结核化疗是淋巴结结核治疗的基础,手术治疗主要针对两种情况,一是对于局部病变早期,浅表淋巴结肿大明显,内科治疗效果不佳。二是针对局部病变中后期,淋巴结溃破形成复杂难治的伤口和窦道,局部换药和内科抗结核治疗下局部病变仍无明显改善的情况。目前浅表淋巴结结核治疗主要是以抗结核化疗结合手术治疗,尚存在明显不足:(1)化疗疗程可达9个月以上,治愈率不足50%,而且即使规范治疗仍有20%的几率出现肿大淋巴结化脓溃破,形成难愈伤口或窦道,增加治疗难度和痛苦,最终留下明显瘢痕;(2)化疗没有效果使部分老年、心肺功能较差不耐受手术患者失去进一步治疗机会;(3)对于施行手术治疗的患者,由于体表淋巴结结核源于多部位、多途径,形成窦道和瘘管较为隐蔽,给完整清除带来困难,手术复发率约10-30%;(4)结核病灶存在较大范围皮下软组织,术后愈合过程中的瘢痕性挛缩伤口产生较大瘢痕致严重影响外观;(5)结核病灶影响到肋骨、锁骨,胸骨等致手术范围广,因胸廓大面积塌陷而致畸甚至致残。目前治疗模式无法对此类患者采取有效的、无创伤的治疗。
浅表淋巴结结核属于中医“瘰疬”的疾病范畴,呈串珠状,其中小者称“瘰”,大者称“疬”,统称为“瘰疬”。有关瘰疬的记载,首见于《灵枢·寒热》:“生于颈项、腋下的寒热瘰疬之症,属于鼠瘘症,是寒热毒气留滞于经脉而不能排除所致。”在中医千年的传承和发展中,对瘰疬的治疗有着丰富经验,针对不同症象有着内服、外敷、针灸等诸多治法,且在临床实践中有着良好的治疗效果。瘰疬根据疾病发展演变规律,分为初期、中期和后期,不同阶段往往有着不同的证候;
1.初期(结节型):(1)外感毒邪证,本证发作较急,属瘰疬中表证、实证,表现为颈项两侧结核,一二枚或更多,初起肿势盲浮,皮色不变,继则转红,灼热,压之疼痛;若外感风毒则伴恶寒发热,舌质红,苔白腻,脉浮数或浮滑;若外感热毒者则发热烦躁,口苦咽干,舌红苔黄腻,脉滑数,若外感四时杀厉不正之气,则骤成肿块,宣发暴肿,色红皮热,身寒热,头痛项强,四肢不舒,脉弦数。(2)肝郁痰凝证本证主因内伤所致,表现为颈项两侧肿块,结核大小不定,皮色如常不痛,质中偏硬,推之可动,伴胸闷胁胀,口苦,纳食不香,舌苔薄白,脉弦或弦滑。
2.中期(肿疡型):(1)寒痰证:肿块按之波动,少有疼痛,皮色不变,面色咣白,畏寒,脘闷纳呆,舌质淡,苔白,脉弦细;(2)热痰证肿块按之波动,皮色暗红微热,伴有疼痛,常兼见两颧潮红,低热盗汗,腰腿酸软,苔少舌红,脉沉弦而数。
3.后期(溃疡型):(1)气血两虚证病程日久,肿块溃破,脓液清稀,每多夹有败絮状物,疮口腐肉
星灰白色,久不收口,伴面色无华,神疲乏力,头晕眼花,舌苔薄白,脉沉或细缓。(2)阴虚火旺证:疮口经久不愈,皮色紫黯,脓稀量少,伴潮热盗汗,五心烦热身体羸瘦,口干颧红,舌尖质红少津,脉细数。
据不同阶段的辨证给与内外综合治疗,初中期主要以消法为主要治疗原则,后期正虚邪恋则需配合补虚托毒治疗。针对初起(结节型),中医理论认为外感毒邪证宜攻坚消肿,化痰散结;风毒者宜祛风胜湿,用防风羌活汤(用于有寒热者)或牛蒡解肌汤(用于身热不寒者);热毒者宜清热解毒,用升阳调经汤或柴胡连翘汤;气毒者,应清肝泻火、攻坚消肿,用连翘散坚汤或舒肝溃坚汤;肝郁痰凝证宜舒肝解郁,化痰散结,用逍遥散合二陈汤加公英,天葵,或以消瘰丸合逍遥散治之;早期(结节型)外治法由于发病较快,有阳毒证候者,可外敷铁箍膏;皮色不变者,可选用消核膏、阳和解凝膏、回阳玉龙膏等。
CN104623157A公开了猫爪草50-100、夏枯草50-100、生南星50-100、白芥子50-80、生半夏30-60、全蝎30-50、芒硝30-50、马钱子10-15磨粉混匀后与加热后微凉的菜籽油和凡士林,按1:3:3的比例混合调制成膏状,直接敷于患处,具有止痛效果好、消肿散结快、疗效好,用药方便等优点;可治疗颈部、腋窝、腹股沟等处浅表淋巴结结核。CN115154550A提供一种治疗溃疡型淋巴结结核的外用中药组合物,由白芨10g,白芷10g,当归10g,乳香5g,没药5g组成,对于气阴两虚型溃疡型淋巴结结核具有显著疗效,可迅速排脓、止痛、生肌;促进炎症的吸收和消散;有效治疗淋巴结结核红肿破溃、皮肤溃烂等;对溃疡、溃后脓血等具有良好的治疗效果。CN102008625A公开了一种治疗淋巴结结核的药物,包括冰片5-9份、鲜山药500份、黑蚱8-12份、蟾蜍3-5份、金蝎5-10份、蜂房9-15份、煅炉甘石9-20份、乳香5-10份、没药5-10份、黄芪10-12份和丹参45份,各组分有机配伍,协同作用,具有独特的渗透功能,以强大的药效直达病灶,内病外治,透皮吸收,达到活血化瘀、温经通络、理气、消结、止痛、祛风排毒,使得本药物产生强大的药效,有效排除机体病灶,达到良好的治疗效果。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、对于肿块坚硬不消者,如醒消丸,采用乳香、没药、麝香、雄黄.共碾制成丸剂。
目前上述治疗淋巴结结核的药物虽然起到了一定的治疗效果,但是缺乏对淋巴结结核不同疾病发展演变规律和时期的针对性的精准治疗,尤其对淋巴结结核初期(结节型)的治疗,多由西药治疗,没有对症的初期外敷用药,其结节散消效果较慢,严重时导致初期结节逐步红肿发展到溃疡。因此,本发明针对初期未溃浅表淋巴结结核,提供一种外用中药,为未溃浅表淋巴结结核提供一种新的治疗方案。
发明内容
淋巴结核患者在淋巴结核初期未溃时中医病症为气滞痰凝,形成症瘕积聚,中后期当肿块红肿热痛内部液化之后,病症转为热毒壅盛,阴虚火旺阶段,再后期溃破后,有脓液外流,病症转为气血不足,脾肾亏虚,本发明主要针对淋巴结核初期气滞痰凝、症瘕积聚阶段的未溃患者提供一种外用中药组合物,用于配合抗结核化学药剂进行辅助治疗,以清热解毒,消肿化痰,散瘀消坚为治则,诸药合用发挥清热解毒,促进肿块吸收缩小,减少淋巴结坏死液化、形成溃疡和窦道的发生几率,从而增加疗效,减少患者治疗创伤和痛苦。
第一方面,本发明提供一种用于治疗未溃浅表淋巴结结核中药组合物外用制剂,以重量份数计,中药组合物外用制剂含有芙蓉叶20~35份,生半夏20~35份,乳香10~18份,没药10-18份,冰片5~8份。
当淋巴结核患者处于初期时,淋巴结结核表现为未溃患者,其由气滞痰凝形成症瘕积聚,针对气滞痰结引起的无红肿热痛的肿块,内治则需要疏肝解郁,滋阴化痰;外治则需散结消肿。本方是对经典玉露膏的改进,称为加味玉露膏,其组方原则是行气化痰,散结消肿,其中玉露膏由一味芙蓉叶构成,有治疗一切阳毒之证功效,可治疗一切疮、疖、肿毒、痈未破时,如丹毒、带状疱疹等,消肿排脓止痛;针对淋巴结结核未溃患者的气滞痰凝、症瘕积聚病症,本发明进一步增加生半夏、乳香、没药和冰片,其中生半夏能够燥湿化痰,消痞散结,用于瘿瘤痰核,痈疽肿毒;乳香、没药配合可活血、行气、止痛,托里护心,活血定痛伸筋,消痈疽诸毒之要药,善治风寒湿痹,周身麻木,四肢不随及一切疮疡肿痛,或其疮硬不疼,外用为粉以敷疮疡,能解毒、消肿、生肌、止痛,不耗伤气血,尤其乳香在本方中治则主要发挥活血破淤的功效,其较活血散瘀的药味更针对未溃浅表淋巴结核的散结消肿,使本方在淋巴结核患者处于初期治疗中效果更显著。
进一步的,本发明所述中药组合物外用制剂包括芙蓉叶25~35份,生半夏20~35份,乳香10~18份,没药10~18份,冰片5~8份。
进一步的,所述中药组合物外用制剂包括芙蓉叶25~33份,生半夏20~33份,乳香10~15份,没药10~15份,冰片5~7份。
进一步,所述中药组合物外用制剂包括芙蓉叶30份,生半夏30份,乳香12份,没药12份,冰片7份。
进一步,所述中药组合物中生半夏也可用制半夏代替;
进一步,所述中药组合物可以进一步添加相应的药用辅料制备为相应的中药制剂,如霜剂、膏剂、糊剂、溶液剂、散记等剂型。
进一步,所述用于外治未溃浅表淋巴结结核的中药组合物的药用辅料包括凡士林、蜂蜜、油剂和/或水等。
第二方面,本发明提供一种用于外治未溃浅表淋巴结结核的中药组合物的制备方法,所述方法包括以下步骤:
S01:按照比例称取芙蓉叶、生半夏、乳香、没药、冰片药物研磨成细末、混匀制成加味玉露散;
S02:加热膏基如凡士林融化成液态后,与S01加味玉露散按5:1调匀;
S03:冷却,备用。
在一种实施方式中,选择中药组合物为膏剂,根据肿块大小应用5~10克,局部涂敷,无菌纱布覆盖,每日贴敷6~12小时,根据皮肤反应采用隔日一次或每日一次,2周为一疗程,一般可治疗2~4个疗程。
第三方面,本发明提供一种第一方面的用于治疗未溃浅表淋巴结结核中药组合物外用制剂在制备治疗未溃浅表淋巴结结核的药物和/联合治疗方案中的应用。
进一步的,所述联合治疗方案的应用包括本发明的治疗未溃浅表淋巴结结核中药组合物外用制剂联合结核病综合治疗方法如抗结核化学药剂的治疗方案中的应用。
本发明中药组合物的有益效果:
针对肿大的浅表淋巴结能够起到消肿散结作用,可以减轻局部炎症反应,促进肿块吸收缩小,减少淋巴结坏死液化、形成溃疡和窦道的发生几率,从而增加疗效,减少患者治疗创伤和痛苦。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面通过具体实施例对本发明做进一步详细说明,应当理解所描述的实施例仅用于解释本发明,并不限定本发明。
参照《中医外科常见病诊疗指南》及《瘰疬外治三法》诊断浅表淋巴结结核的病症表现为:
初起单个或多个核状肿块,推之可移,皮色不变,亦不疼痛。病情发展:核块与皮肤粘连,有轻度疼痛。化脓时皮色转为暗红,肿块变软,脓肿破溃后脓液稀薄,夹有败絮。疮口潜行,久不愈合,可形成窦道。
(1)阴证者症见:肿块大小如豆,一枚至数枚,皮色不变,按之坚实,推之能动,不热不痛。
(2)阳证者症见:颈项部结块逐渐增大与表面粘连或相互融合成块,推之不动,皮色发红,触之有轻微波动感伴压痛证兼有热象,灼痛明显,增大迅速者。
实施例
制备例1:外用加味玉露膏
处方:芙蓉叶30g,生半夏30g,乳香12g,没药12g,冰片7g。
制备方法:称取芙蓉叶,生半夏,乳香,没药,冰片并研成细末,制成加味玉露散;医用凡士林加热液化与加味玉露散按5:1调匀,冷却即成加味玉露膏。应用时,局部涂敷,无菌纱布覆盖。
制备例2:外用加味玉露膏
处方:芙蓉叶25g,生半夏25g,乳香18g,没药18g,冰片5g。
制备方法:称取芙蓉叶,生半夏,乳香,没药,冰片并研成细末,制成加味玉露散;医用凡士林加热液化与加味玉露散按5:1调匀,冷却即成加味玉露膏。应用时,局部涂敷,无菌纱布覆盖。
制备例3:外用加味玉露膏
处方:芙蓉叶35g,生半夏35g,乳香10g,没药10g,冰片8g。
制备方法:称取芙蓉叶,生半夏,乳香,没药,冰片并研成细末,制成加味玉露散;医用凡士林加热液化与加味玉露散按5:1调匀,冷却即成加味玉露膏。应用时,局部涂敷,无菌纱布覆盖。
实施例4:浅表淋巴结结核患者的队列研究
临床疗效观察
对北京胸科医院2021年12月至2022年8月门诊及住院浅表淋巴结核患者21例患者进行临床观察,参照《临床结核病学》。
1、浅表淋巴结结核患者诊断标准
(1)阴证者症见:肿块大小如豆,一枚至数枚,皮色不变,按之坚实,推之能动,不热不痛。
(2)阳证者症见:颈项部结块逐渐增大与表面粘连或相互融合成块,推之不动,皮色发红,触之有轻微波动感伴压痛证兼有热象,灼痛明显,增大迅速者。
2、浅表淋巴结结核患者介绍
其中年龄最大56,最小16岁,平均年龄35.2岁(±11.3岁);男8例,女23例;平均病程4.3个月(±1.9月);有效10例(47.6%),显效5例(23.8%),无效6例(28.5%)。
3、治疗
对21例浅表淋巴结结核患者进行了队列研究,采用制备例1的加味玉露膏贴敷治疗,隔日一次,治疗8周;
4、疗效标准
显效:局部体征评分及淋巴结纵横径乘积减少大于等于50%,且局部无新发病例;
有效:局部体征评分及淋巴结纵横径乘积减少大于等于20%小于50%,且局部无新发病例;
5、治疗效果显示
显效20%,有效50%,总有效率70%。
典型病例
实施例5
贾某某,女,13岁,2021年7月26日初诊,诊断淋巴结结核5个月,利福平、异烟肼、吡嗪酰胺、乙胺丁醇治疗至今,肝肾功能未见异常。就诊中医结核门诊,见颈部多发包块,肉眼可见5处肿大,伴有不同程度局部红肿疼痛,大者右侧锁骨上,达到约4*3cm,伴有局部红肿疼痛拒按,b超显示未见明显液化。门诊给与实施例1加味玉露膏外敷,采用每日一次,每次4小时,治疗2周后复诊,颈部疼痛明显减轻仅有少许不适感,治疗1月复查b超,显示肿大淋巴结纵横经乘机值减小达到30%,局部除肿块外,已无不适感。继续治疗2月,淋巴结肿大缩小50%,局部皮色正常,无压痛无水肿。该间断外敷,6个月后随访,颈部淋巴结缩小达到70%,并保持稳定。
实施例6
梁某,男,30岁,2021年10月18日首次就诊,患者诊断颈部淋巴结结核,HRZE抗结核治疗2月,但颈部肿大淋巴结无变化,触诊肿块明显,活动良好,局部无红肿疼痛,全身无明显不适。给与实施例1加味玉露膏贴敷治疗,1月后复诊,颈部肿块明显缩小,贴敷2月复查b超,颈部肿大淋巴结缩小达到50%,半年后随访,病情稳定,b超显示颈部淋巴结仅有1.3*0.6cm,且触诊已无法发现肿块。
实施例7
吴某某,2022年3月,颈部淋巴结核手术,术后1月复查,颈部淋巴结再次出现肿大,右侧大者1.5*0.8cm,继续抗结核治疗,5月复查,淋巴结增大至1.8*0.9cm,6月9日复查进一步增大到2.4*1.9cm,患者于2022年6月13日中医结核门诊就诊,给与实施例1加味玉露膏贴敷外治,7月11日复查b超,原肿大淋巴结稳定未再进一步增大,2.4*1.6cm。患者继续外敷治疗,8月9日复查显示颈部淋巴结明显缩小到1.1*0.5cm,停止敷药,继续联合抗结核治疗。
Claims (7)
1.一种用于外治初期未溃浅表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:芙蓉叶20~35份 ,生半夏20~35份,乳香10~18份,没药10-18份和冰片5~8份。
2.根据权利要求1所述的用于外治初期未溃浅表淋巴结结核的中药组合物,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:芙蓉叶25~35份 ,生半夏20~35份,乳香10~18份,没药10~18份和冰片5~8份。
3.根据权利要求1所述的用于外治初期未溃浅表淋巴结结核的中药组合物,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:芙蓉叶25~33份,生半夏20~33份,乳香10~15份,没药10~15份和冰片5~7份。
4.根据权利要求1所述的用于外治初期未溃浅表淋巴结结核的中药组合物,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:芙蓉叶30份,生半夏30份,乳香12份,没药12份和冰片7份。
5.一种用于治疗初期未溃浅表淋巴结结核的外用制剂,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药用辅料。
6.根据权利要求5所述的用于治疗初期未溃浅表淋巴结结核的外用制剂,其特征在于,所述制剂为膏剂。
7.根据权利要求1-4任意一项所述的中药组合物在制备治疗初期未溃浅表淋巴结结核的外用制剂中的应用。
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