CN105396000A - 治疗肺结核的中药组合物及制备方法 - Google Patents
治疗肺结核的中药组合物及制备方法 Download PDFInfo
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Abstract
本发明提供了一种用于治疗肺结核的中药组合物,其包括:党参、茯苓、黄芪、山慈菇、大枣、川芎、茜草、白术、白扁豆、水蛭、天竺黄、桂枝、肉豆蔻、薏苡仁、红花、赤芍、猫爪草、葶苈子、炙百部、夏枯草、黄芩、金银花、地骨皮、昆布和鸡内金。采用这种中药组合物在治疗肺结核方面具有疗效好、无不良反应的优点。
Description
技术领域
本发明涉及医药领域,尤其涉及一种用于治疗肺结核的中药制剂。
背景技术
肺结核是临床上比较常见的一种乙类传染病,该病患者大多数伴有活动能力下降及明显的不适症状,如果不能对病情进行及时有效的控制,迁延不愈,甚至会导致患者死亡。据世界卫生组织报道,肺结核目前仍是危害人类健康的重要传染病之一,并把我国、印度、南非等22个国家列为结核病高危险、高负担国家,对肺结核的防治亦成为全球关注的公共卫生和社会问题。相关研究表明中医药在治疗肺结核方面具有显著疗效。
中药作为传统药物在治疗肺结核方面具有独特的优势,其主要是在中医理论的指导下对肺结核患者进行分型,并针对不同类型患者的各自临床表现进行辨证施治,从而能够有效改善或消除如潮热、盗汗、咳嗽、咳血等肺结核的相关临床症状。肺结核是一种感染结核分枝杆菌所致的肺部感染性疾病,属于祖国医学“肺痨”的范畴。临床以咳嗽为首发症状,伴随发热、咯血、胸痛等,肺结核阴虚火旺型以咳嗽、咯血、五心烦热、盗汗等为主要症状。随着病情的逐步发展可以进展为阳虚或血虚等症状,也可表现为营养不良[8]。但无论是阴、阳、气、血的亏虚,还是营养不良,均会对本病的恢复和最终治愈带来一定的障碍。而中药主要是按中医辩证分型的结果实行针对性的用药方案,故药物作用方式安全、准确,避免了因大量应用抗结核药物而造成多重耐药菌株的迅速增加。
开发一种能够快速见效、副作用小、并疗效好的中药是广大患者的迫切需求,本发明基于此公开。
发明内容
本发明所要解决的技术问题在于,克服现有西药治疗肺结核的不足,提供一种能够快速见效、副作用小、并疗效好的中药制剂。
为了解决上述技术问题,本发明提供了一种用于治疗肺结核的中药组合物,其包括:党参、茯苓、黄芪、山慈菇、大枣、川芎、茜草、白术、红花、白扁豆、水蛭、天竺黄、桂枝、肉豆蔻、薏苡仁、赤芍、猫爪草、葶苈子、炙百部、夏枯草、黄芩、金银花、地骨皮、昆布和鸡内金。
其中,各种组份的重量份数比为,党参40-60重量份、茯苓10-20重量份、黄芪10-20重量份、山慈菇10-15重量份、大枣30-50重量份、川芎10-20重量份、茜草1-5重量份、白术10-20重量份、红花10-20重量份、白扁豆5-10重量份、水蛭1-5重量份、天竺黄5-10重量份、桂枝10-20重量份、肉豆蔻10-20重量份、薏苡仁20-30重量份、赤芍10-20重量份、猫爪草10-20重量份、葶苈子5-10重量份、炙百部10-20重量份、夏枯草5-10重量份、黄芩5-15重量份、金银花10-20重量份、地骨皮10-20重量份、昆布10-20重量份和鸡内金10-20重量份。
优选加入香橼皮,含量优选为10-20重量份
为解决上述技术问题,本发明还提供了上述中药组合物的制备方法,其包括:
将党参、茯苓、黄芪、山慈菇、大枣、川芎、茜草、白术、红花、白扁豆、水蛭、天竺黄、桂枝、肉豆蔻、薏苡仁、赤芍、猫爪草、葶苈子、炙百部、夏枯草、黄芩、金银花、地骨皮、昆布和鸡内金按比例混合,加水煎煮两次,每次煎煮1-1.5小时,合并煎煮液、过滤,得到汤剂。
也可以采用公知的制剂方法制成各种其他剂型,如口服液、颗粒剂、注射剂、胶囊等
口服液的制备方法如下:
将党参、茯苓、黄芪、山慈菇、大枣、川芎、茜草、白术、红花、白扁豆、水蛭、天竺黄、桂枝、肉豆蔻、薏苡仁、赤芍、猫爪草、葶苈子、炙百部、夏枯草、黄芩、金银花、地骨皮、昆布和鸡内金按比例混合,加水煎煮两次,每次煎煮1-1.5h,合并煎煮液、过滤,滤液浓缩成相对密度为1.10-1.25(50℃)的清膏,4-10℃冷却,清膏中加入水、蔗糖粉、活性炭,依次进行加热处理、过滤处理、灌封处理、灭菌处理,得到口服液;所述的滤液与蔗糖粉的重量比为1∶0.1-0.4;所述的滤液与活性炭的重量比为1∶0.002-0.003;所述的加热处理时间为30-40分钟,温度为100℃,所述口服液中的生药浓度为0.1g/mL-0.3g/mL。
相对于现有技术中的用于治疗肺结核的药物,采用本发明的中药组合物对肺结核的治疗具有能够快速见效、副作用小、并疗效好等优点。
具体实施方式
本发明中使用的中药成分的药物特性如下:
党参:性平,味甘、微酸,归脾、肺经,起到补中益气,健脾益肺的作用,用于脾肺虚弱,食欲不振,倦怠乏力,气短心悸,气血两虚,虚喘咳嗽,内热消渴等证,党参能增强机体免疫功能,增强清除自由基的能力,对心血管系统各个部分有一定的调节作用,常用于治疗冠心病。
茯苓:味甘、淡,性平,归心、肺、脾、肾经,利水渗湿,健脾,宁心;用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
黄芪:味甘,性温,入脾、肺经,有补益脾土,升举阳气、固表止汗,托疮生肌等作用,主要用于脾肺气虚所致之乏力食少便溏,心悸气短,中气下陷之脏器下垂,气不摄血之崩漏便血,久泻脱肛;表虚不固之自汗盗汗,气血不足等证。黄芪使心脏收缩能力增强,能改善全身的血液循环,能扩张冠状动脉、肾血管及拳参末梢血管、使皮肤血液循环旺盛;能提高机体的非特异免疫力,有保肝和降低血糖的作用,对葡萄球菌、血溶性链球菌、肺炎双球菌、痢疾杆菌等有抑制作用。黄芪可显著影响脾淋巴细胞信息传导,实现免疫调节作用,对细胞代谢及心血管系统有显著效应,大剂量的应用黄芪能推动气血的正常运行,改善心功能,消除体循环障碍,现代药理证明,黄芪能清除体内自由基,使超氧化物歧化酶活力增强,过氧化脂质含量降低,具有抗病毒、扩血管、利尿、免疫调节作用,能明显增强心肌收缩力,使心排血量及心脏指数明显增加,有利于减轻心脏负荷。
山慈菇:山慈菇味甘、微辛,性凉。具有清热解毒,消痈散结等功效,常用于痈肿疔毒,瘰疬痰核,蛇虫咬伤,瘸瘕痞块。
大枣:味甘,性温,入脾、胃经,具有补气健脾、养血安神、调和营卫、缓和药性的作用,用于脾胃虚弱,体倦乏力,食少便溏,气血不足,头痛发热,汗出热风等证,大枣具有增强肌力的作用,具有增加血清总蛋白和白蛋白的功能。大枣中含有丰富的维生素C、维生素P,对健全毛细血管、维持血管壁弹性,抗动脉粥样硬化很有益;大枣中含有cAMP,其药理作用表现为改善人体微循环,扩张冠状动脉,增加脑和心脏的供血量,减慢心律,降低心肌耗氧量而改善缺血心肌的代谢,故可防治心脑血管病。
川芎:性辛,味温,入肝、胆经,行气开郁,法风燥湿,活血止痛。治风冷头痛旋晕,胁痛腹疼,寒痹筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
茜草:性寒,味苦,归肝经,功效:凉血止血;活血化瘀,主治:血热咯血;吐血;衄血;尿血;便血;崩漏;经闭;产后瘀阻腹痛;跌打损伤;风湿痹痛;黄疸;疮痈;痔肿,茜草对急性心肌缺血有保护作用,对黄金色葡萄球菌、肺炎链球菌、流感杆菌有抑制作用。
白术:味苦,甘,性温。归脾、胃经,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
红花:性温,味辛,入、心、肝经,具有活血通经,祛瘀止痛的作用,用于闭经,痛经,恶露不行,症瘕痞块,跌扑损伤,疮疡肿痛等症。
白扁豆:味甘,微温。归脾、胃经;健脾化湿,和中消暑。用于脾胃虚弱,食欲不振,大便溏泻,白带过多,暑湿吐泻,胸闷腹胀。炒白扁豆健脾化湿。用于脾虚泄泻,白带过多
水蛭:味咸、苦,性平,入肝经,具有破血逐瘀的功效,用于血淤闭经,症瘕腹痛、蓄血、损伤瘀血作痛、痈肿丹毒等症的治疗,水蛭能消除动脉周扬硬化斑块,增加心肌营养性血流量,改善心率失常。
天竺黄:味甘,性寒,归心、肝经,清热豁痰,凉心定惊,用于热病神昏,中风痰迷,小儿痰热惊痫、抽搐、夜啼。
桂枝:味辛、甘,性温,归心、肺、膀胱经,具有发汗解肌,温经通脉,助阳化气,散寒止痛的作用,桂枝温经通脉,横通肢节,用于外感风寒表证,不论有汗、无汗均可应用,亦用于风湿痹痛、胃寒腹痛、经闭、痛经,风湿痹痛,肩臂肢节冷痛等证,痰饮证和膀胱蓄水,心脾阳虚,水湿内停,胸胁胀满,咳逆头晕等痰饮证。
肉豆蔻:味辛;苦;温,归脾;胃;大肠经;温中涩肠;行气消食。主虚泻;冷痢;脘腹胀痛;食少呕吐;宿食不消。
薏苡仁:性凉,味甘、淡,归脾、胃、肺经。具有健脾渗湿、清热排脓、除痹、利水的功能,用于脾胃虚弱,便溏腹泻,或妇女带下病,脾虚湿盛水肿,小便不利,或脚气肿痛;湿热痹痛,手足拘挛,酸楚疼痛;肺痈咳唾脓痰,或肠痛拘急腹痛。《本草正》:薏苡,味甘淡,气微凉,性微降而渗,故能去湿利水,以其志湿,故能利关节,除脚气,治痿弱拘挛湿痹,消水肿疼痛,利小便热淋,亦杀蛔虫。以其微降,故亦治咳嗽唾脓,利膈开胃。以其性凉,故能清热,止烦渴、上气。但其功力甚缓,用为佐使宜倍。薏苡仁可以促进体内血液和水分的新陈代谢,有利尿、消水肿等作用。
赤芍:味苦,性微寒。归肝经。具有清热凉血、散瘀止痛的功能,用于温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,症瘕腹痛,跌扑损伤,痈肿疮疡等证。
猫爪草:性味甘辛,温,入肝、肺二经,化痰散结,解毒消肿,治疗耐多药肺结核,尤其是耐异烟肼、利福平和链霉素的患者,治肺结核,疟疾,瘰疬痰核,疔疮,虫蛇咬伤,偏头痛,疟疾,牙痛。淋巴结结核,淋巴结炎,咽喉炎。
葶苈子:味辛,苦,性寒,入肺、心、肝、胃、膀胱经,具有泻肺降气,祛痰平喘,利水消肿,泄逐邪的功效,主治痰涎壅肺之喘咳痰多;肺痈;水肿;胸腹积水;小便不利;慢性肺源性心脏病;心力衰竭之喘肿;瘰疬结核,葶苈子具有强心的作用,能增强心肌收缩力。
炙百部:性甘,味苦,微温,常用于润肺止咳,灭虱杀虫。
夏枯草:性辛、苦,寒。归肝、胆经;清热泻火,明目,散结消肿。常用于1.目赤肿痛、头痛眩晕、目珠夜痛。本品苦寒主入肝经,善泻肝火以明目。用治肝火上炎,目赤肿痛,可配桑叶、菊花、决明子等药用。本品清肝明目之中,略兼养肝,配当归、枸杞子,可用于肝阴不足,目珠疼痛,至夜尤甚者;亦可配香附、甘草用,如夏枯草散(《张氏医通》)。2.瘰疬、瘿瘤。本品味辛能散结,苦寒能泄热,常配贝母、香附等药用以治肝郁化火,痰火凝聚之瘰疬,如夏枯草汤(《外科正宗》);用治瘿瘤,则常配昆布、玄参等用,如夏枯草膏(《医宗金鉴》)。3.乳痈肿痛。本品既能清热去肝火,又能散结消肿,可治乳痈肿痛,常与蒲公英同用(《本草汇言》)。若配金银花,可治热毒疮疡,如化毒丹(《青囊秘传》)。
黄芩:黄芩的根入药,味苦、性寒,有清热燥湿、泻火解毒、止血、安胎等功效。主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症。
金银花:金银花性寒,味甘,入肺、心、胃经,具有清热解毒、抗炎、补虚疗风的功效,主治胀满下疾、温病发热,热毒痈疡和肿瘤等症。其对于头昏头晕、口干作渴、多汗烦闷、肠炎、菌痢、麻疹、肺炎、乙脑、流脑、急性乳腺炎、败血症、阑尾炎、皮肤感染、痈疽疗疮、丹毒、腮腺炎、化脓性扁桃体炎等病症均有一定疗效。
地骨皮:性味:性寒,味甘;凉血除蒸,清肺降火。用于阴虚潮热、骨蒸盗汗、肺热咳嗽、咯血、衄血。内热消渴。
昆布:昆布气腥,味咸。归肝、胃、肾经。有软坚散结,消痰,利水之功能。用于痰饮水肿。软坚散结,消痰,利水。瘿瘤、瘰疬、睾丸肿痛、痰饮水肿。
鸡内金:味甘,性平。归脾、胃、小肠、膀胱经。健胃消食,涩精止遗,通淋化石。用于食积不消,呕吐泻痢,小儿疳积,遗尿,遗精,石淋涩痛,胆胀胁痛。
优选所述中药组合物仅由上述组分构成。
各种组份含量优选为:党参40-50重量份、茯苓10-20重量份、黄芪15-20重量份、山慈菇10-15重量份、大枣30-50重量份、川芎10-20重量份、茜草1-5重量份、白术10-20重量份、红花10-20重量份、白扁豆5-10重量份、水蛭1-4重量份、天竺黄5-10重量份、桂枝15-20重量份、肉豆蔻10-20重量份、薏苡仁25-30重量份、赤芍10-20重量份、猫爪草10-20重量份、葶苈子5-10重量份、炙百部15-20重量份、夏枯草5-10重量份、黄芩10-15重量份、金银花10-20重量份、地骨皮10-20重量份、昆布10-20重量份和鸡内金15-20重量份。可选的加入香橼皮,含量优选为10-20重量份
进一步优选为:党参40-50重量份、茯苓15-20重量份、黄芪15-20重量份、山慈菇10-15重量份、大枣30-40重量份、川芎10-15重量份、茜草1-5重量份、白术10-20重量份、红花10-15重量份、白扁豆5-10重量份、水蛭1-4重量份、天竺黄5-10重量份、桂枝15-20重量份、肉豆蔻10-20重量份、薏苡仁25-30重量份、赤芍10-15重量份、猫爪草15-20重量份、葶苈子5-10重量份、炙百部15-20重量份、夏枯草5-10重量份、黄芩10-15重量份、金银花15-20重量份、地骨皮15-20重量份、昆布10-20重量份和鸡内金15-20重量份。可选的加入香橼皮,含量优选为15-20重量份
具体制备实施例如下:
本发明中药汤剂1的制备
将党参50g、茯苓10g、黄芪15g、山慈菇12g、大枣40g、川芎20g、茜草2g、白术15g、红花20g、白扁豆5g、水蛭4g、天竺黄5g、桂枝20g、肉豆蔻20g、薏苡仁25g、赤芍10g、猫爪草10g、葶苈子5g、炙百部15g、夏枯草5g、黄芩10g、金银花10g、地骨皮20g、昆布10g和鸡内金20g按比例混合,加水煎煮两次,每次煎煮1-1.5小时,合并煎煮液、过滤,得到汤剂。
本发明中药汤剂2的制备
将党参50g、茯苓15g、黄芪20g、山慈菇15g、大枣30g、川芎12g、茜草3g、白术10-20g、红花15g、白扁豆6g、水蛭3g、天竺黄8g、桂枝20g、肉豆蔻10-20g、薏苡仁25g、赤芍12g、猫爪草15g、葶苈子5g、炙百部15-20g、夏枯草5g、黄芩10g、金银花17g、地骨皮18g、昆布10g、鸡内金15g、香橼皮15g按比例混合,加水煎煮两次,每次煎煮1-1.5小时,合并煎煮液、过滤,得到汤剂。
本发明口服液1的制备
将党参50g、茯苓15g、黄芪20g、山慈菇15g、大枣30g、川芎12g、茜草3g、白术10-20g、红花15g、白扁豆6g、水蛭3g、天竺黄8g、桂枝20g、肉豆蔻10-20g、薏苡仁25g、赤芍12g、猫爪草15g、葶苈子5g、炙百部15-20g、夏枯草5g、黄芩10g、金银花17g、地骨皮18g、昆布10g、鸡内金15g按比例混合,加水煎煮两次,每次煎煮1-1.5小时,合并煎煮液、过滤,滤液浓缩成相对密度为1.20(50℃)的清膏,4-10℃冷却,清膏中加入适量水、蔗糖粉、活性炭,100℃加热30分钟、过滤处理、灌封处理、灭菌处理,得到的口服液中的生药浓度为0.2g/mL。
本发明口服液2的制备
将党参50g、茯苓15g、黄芪20g、山慈菇15g、大枣30g、川芎12g、茜草3g、白术10-20g、红花15g、白扁豆6g、水蛭3g、天竺黄8g、桂枝20g、肉豆蔻10-20g、薏苡仁25g、赤芍12g、猫爪草15g、葶苈子5g、炙百部15-20g、夏枯草5g、黄芩10g、金银花17g、地骨皮18g、昆布10g、鸡内金15g、香橼皮15g按比例混合,加水煎煮两次,每次煎煮1-1.5小时,合并煎煮液、过滤,滤液浓缩成相对密度为1.20(50℃)的清膏,4-10℃冷却,清膏中加入适量水、蔗糖粉、活性炭,100℃加热30分钟、过滤处理、灌封处理、灭菌处理,得到的口服液中的生药浓度为0.2g/mL。
临床数据:
病例选择:选取100例肺结核患者为研究对象,其中男性69例,女性31例;年龄28-69岁,病程2-14年,其中,毁损肺36例,肺结核空洞形成或伴痰菌迁延阳性31例,肺结核空洞形成伴曲菌球15例,肺结核伴结核性脓胸10例,肺结核局限性的耐药结核4例,肺结核伴长期肺不张4例,所有患者肺结核确诊均符合中华医学会结核病学分会2001年制定的《肺结核诊断标准》,肺部感染诊断标准为卫生部制定的《医院感染诊断标准》
将入选病例随机分为治疗组1、2与对照组,治疗组1共35例,治疗组2共35例,对照组30例。
治疗方法
对照组:用异烟肼4mg/kg,1日1次。
治疗组1:口服本发明中药口服液1,每次10mL,每日3次;
治疗组2:口服本发明中药口服液2,每次10mL,每日3次。
两组均1个月为一疗程,治疗2个疗程。
疗效标准
显效:肺结核症状消失,体质恢复正常。
有效:肺结核症状明显好转,体质逐步恢复。
无效:达不到好转标准。
治疗结果比较
与对照组相比,采用本发明的中药口服液在总有效率和显效数上均有明显改善。
治疗组2相对于治疗组1而言,在总有效率上更有显著提高,而且见效更快,在第一个疗程,显效比例达到76.3%显著高于治疗组1的65.7%以及对照组的40%。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (5)
1.一种用于治疗肺结核的中药组合物,其包括:党参、茯苓、黄芪、山慈菇、大枣、川芎、茜草、白术、红花、白扁豆、水蛭、天竺黄、桂枝、肉豆蔻、薏苡仁、赤芍、猫爪草、葶苈子、炙百部、夏枯草、黄芩、金银花、地骨皮、昆布和鸡内金。
2.如权利要求1所述的中药组合物,其中,各种组份的重量份数比为,党参40-60重量份、茯苓10-20重量份、黄芪10-20重量份、山慈菇10-15重量份、大枣30-50重量份、川芎10-20重量份、茜草1-5重量份、白术10-20重量份、红花10-20重量份、白扁豆5-10重量份、水蛭1-5重量份、天竺黄5-10重量份、桂枝10-20重量份、肉豆蔻10-20重量份、薏苡仁20-30重量份、赤芍10-20重量份、猫爪草10-20重量份、葶苈子5-10重量份、炙百部10-20重量份、夏枯草5-10重量份、黄芩5-15重量份、金银花10-20重量份、地骨皮10-20重量份、昆布10-20重量份和鸡内金10-20重量份。
3.如权利要求1所述的中药组合物,其中,组合物中还包括香橼皮,含量优选为10-20重量份。
4.权利要求1-3所述的中药组合物的制备方法,其特征在于,包括:
将权利要求1-3的组合物按比例混合,加水煎煮两次,每次煎煮1-1.5h,合并煎煮液、过滤,滤液浓缩成相对密度为1.10-1.25(50℃)的清膏,4-10℃冷却,清膏中加入水、蔗糖粉、活性炭,依次进行加热处理、过滤处理、灌封处理、灭菌处理,得到口服液;所述的滤液与蔗糖粉的重量比为1∶0.1-0.4;所述的滤液与活性炭的重量比为1∶0.002-0.003;所述的加热处理时间为30-40分钟,温度为100℃,所述口服液中的生药浓度为0.1g/mL-0.3g/mL。
5.权利要求1-3所述的中药组合物在治疗肺结核中的用途。
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