CN107050341A - 一种润肺镇咳的中药组合物及其制备方法 - Google Patents
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Abstract
本发明提供一种润肺镇咳的中药组合物及其制备方法,所述中药组合物的活性成分包括以下原料:制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、薄荷、湘莲全株和南阳梨,其具有清热解痰、养阴润肺、镇咳祛痰、降压安神的功效,且效果良好;本发明提供的制备方法,工艺简单,成本低廉,环境污染小。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种润肺镇咳的中药组合物及其制备方法。
背景技术
由于社会的老龄化以及环境污染的加剧,呼吸系统疾病的发病率不断上升。咳嗽是呼吸道感染、哮喘、慢性肺阻塞性疾病(COPD)、嗜酸粒细胞性支气管炎(EB)和肺癌等疾病的常见症状,每年全世界用于治疗咳嗽的药物社会经济开支高达几十亿美元,当前应用最多的镇咳药物大部分是西药,如磷酸可待因、右美沙芬、咳必清等。西药止咳大多作用于中枢神经,镇静,便秘,恶心呕吐等容易产生副作用;且临床对病因不清的非特异性咳嗽治疗效果较差。
咳嗽分外感咳嗽与内伤咳嗽,均是病邪引起肺气不清失于宣肃,迫气上逆而作咳,风寒袭肺、风热犯肺、风燥伤肺、痰湿蕴肺、肝火犯肺、肺阴亏耗。中医对咳嗽的治疗,除直接治肺外,从整体出发注意治脾、治肝、治肾等。外感咳嗽一般均忌敛涩留邪,当因势利导,俟肺气宣畅则咳嗽自止;内伤咳嗽应防宣散伤正,注意调理脏腑,顾护正气。咳嗽是人体祛邪外达的一种病理表现,治疗决不能单纯见咳止咳,必须按照不同的病因分别处理。
中医药治疗咳嗽有悠久的历史,许多预防和治疗咳嗽的中草药和复方已经应用了几千年,实践表明在预防和治疗咳嗽方面具有很好的临床疗效,这为我们从中寻找具有良好药效,副作用小,安全稳定的药物奠定了很好的临床基础。
CN201310642235.6公开一种用于咳嗽的中药,它是由以下重量份数的原料制成:旱半夏10-20份、茯苓20-40份、陈皮5-10份、甘草5—10份、炙麻黄5-10份、杏仁5-10份、款冬花5—10份、旋复花15-25份、百部5-10份、乌梅2-5份、橘梗2-5份、瓜蒌5-15份、胖大海5-15份、川贝母2-5份、马兜铃2-5份、半夏2-5份。该中药组合物治疗效果不明显,具有一定的局限性。
CN201510978206.6公开一种治疗咳嗽的中药,其中药原料及重量份配比为:甘草5~20份,杏仁10~20份,陈皮5~15份,玉竹10~20份,紫苑10~20份,五味子3~6份,太子参15~20份。该中药组合物养阴清肺效果不足。
发明内容
基于此,有必要提供一种润肺镇咳的中药组合物,具有清热解痰、养阴润肺、镇咳祛痰、降压安神的功效,且效果良好;以及提供一种润肺镇咳的中药组合物的制备方法,方法的工艺简单,成本低廉,环境污染小。
一方面,本发明的目的在于提供一种润肺镇咳的中药组合物,其活性成分包括以下原料:制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、薄荷、湘莲全株和南阳梨。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹15~20份、芦根10~15份、鲜冬桑叶5~10份、孔雀草5~10份、罗汉果1~5份、薄荷1~5份、南阳梨5~10份和湘莲全株40~45份。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,其活性成分还包括以下重量份的原料:制玉竹16份、芦根13份、鲜冬桑叶9份、孔雀草9份、罗汉果3份、薄荷2份、南阳梨6份和湘莲全株41份。
一方面,本发明的目的在于提供一种润肺镇咳的中药组合物,其包含药学上可接受的辅料。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述辅料包含稀释剂、润滑剂和矫味剂。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述辅料包含稀释剂2~8份、润滑剂1~5份、矫味剂1~4份。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述辅料包含稀释剂2~5份、润滑剂1~3份、矫味剂1~3份。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述辅料还包括润湿剂。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述辅料还包括润湿剂0~10份。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述稀释剂为糊精、淀粉、甘露醇、微晶纤维素、可溶性淀粉、麦芽糖、乳糖中的至少一种。
所述润滑剂为硬脂酸镁。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述润湿剂为含1%~6%PVPK30的70%~98%乙醇溶液、十二烷基硫酸钠、十二烷基苯磺酸钠或吐温-60。PVPK30为聚维酮。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,所述矫味剂为木糖醇、甘草甜素、阿斯巴甜、甜菊素、果糖、麦芽糖醇、香蕉香精、菠萝香精、香兰素、薄荷香精中的至少一种。
进一步地,本发明的目的在于提供一种润肺镇咳的中药组合物,其剂型为片剂、颗粒剂、散剂、口服液、丸剂、胶囊、合剂、流浸膏、分散片、糖浆剂、酒剂与酊剂、汤剂。
本发明的药物组分,药的重量是以生药计算的,以重量作为配比,在小规模或大规模生产时可按照比例增大或减少,各组成之间的生药材重量配比的比例不变。本发明的药物组分的重量配比的比例是经过科学筛选得到的,对于特殊病人,如重症或轻症,肥胖或瘦小的病人,可以相应调整组成的量的配比,增加或减少不超过100%。
另一方面,本发明提供一种润肺镇咳的中药组合物的制备方法,包括以下步骤:
(1)按预定重量比分别称取原料药制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、南阳梨、湘莲全株,用粉碎机粉碎至10目后,加水浸泡,回流提取,过滤得滤液A和滤渣,备用;
(2)将步骤(1)所得滤渣加水浸泡,回流提取,过滤,压榨药渣,得滤液B,备用;
(3)合并滤液A和滤液B,静置过滤,滤液减压浓缩,得到相对密度为1.25~1.30的清膏,将清膏减压干燥后,粉碎,过80目筛,得干浸膏粉,备用;
(4)干浸膏粉置于搅拌机中,用水或乙醇制成软材,将制好的软材用14~24目筛的制粒机进行制粒,在向制粒机中加软材的同时加干浸膏粉,直至制备颗粒完成;
(5)将颗粒在鼓风干燥箱中干燥,冷却后,喷入薄荷乙醇溶液,密闭2h,
(6)向颗粒中加入预定重量比辅料,混匀,用24目筛的震荡整粒机整粒筛分1~3次,制成24目的颗粒,将颗粒压片,即得中药组合物。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,其中步骤(1)中的制玉竹制备过程如下:将玉竹洗净捞出沥干,经第一次蒸汽蒸煮、第一次发酵、恒温通风干燥、第二次蒸汽复蒸、第二次发酵后取出,切厚片,混入25%炼蜜后,烘干,得制玉竹。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,其中步骤(1)中的制玉竹制备过程如下:将玉竹洗净捞出沥干,经100℃蒸汽蒸煮2h、30℃发酵12h后取出、50℃恒温通风干燥4h、100℃蒸汽蒸煮4h、30℃发酵12h后取出,切厚片,混入25%炼蜜后,85℃烘干,得制玉竹,含水量约15%。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,所述步骤(1)中加水浸泡的时间为0.5~1h,所用水量为原料药体积的10~15倍,所述回流提取的时间为0.5~2.0h。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,所述步骤(2)中加水浸泡的时间为0.5~1h,所用水量为原料药体积的10~15倍,所述回流提取的时间为0.5~2.0h。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,所述步骤(3)中减压干燥的温度为40~60℃。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,所述步骤(4)中软材和干浸膏粉的重量比为3~6:0.5~1。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,所述步骤(5)中鼓风干燥箱中干燥的温度为60~80℃。
进一步地,本发明提供一种润肺镇咳的中药组合物的制备方法,所述步骤(5)中薄荷乙醇溶液的制备过程如下:取预定重量比的薄荷,加入1~5倍体积的浓度为75%的乙醇进行回流提取0.5~1h,过滤,制得。
本发明中各原料的药理作用如下:
玉竹:味甘,性微寒,归肺经、胃经,具有养阴润燥,生津止渴的功能,用于肺胃阴伤,燥热咳嗽,咽千口渴,内热消渴等,生用以生津止渴为主,用于素体阴虚,发热咳嗽,口渴咽痛,或燥邪伤津,口干舌燥,或胃火炽盛,烦渴善饥等。
制玉竹,经蒸制后,味甘,以滋阴益气为主,用于虚劳干咳,或热病后期,阴液耗损,或热病中期,下后汗出,口干咽燥等;蜜制程序可增加甙元的溶解度,增强其润肺镇咳的作用,同时还能帮助促进吸收。
芦根,味甘,性寒,归肺经、胃经,清热生津,除烦,止呕,利尿;用于热病烦渴、胃热呕吐、肺热咳嗽、肺痈吐脓、热淋涩痛。
冬桑叶,味甘、苦,性寒,归肺经、肝经;主要用于风热感冒,或肺部有郁热燥咳;或肝经郁热所致的头晕头痛,目赤昏花,目雾迎风流泪等。并有防治风热感冒、肺热燥咳、咽喉肿痛、血虚头痛、眼部疲劳、习惯性便秘、小便不利、风湿性关节痛、还有助于降血压、降血糖、降血脂、预防脑血栓、减肥、保健等功能。
孔雀草,味苦,性凉;有清热利湿,止咳之功效。用于咳嗽,痢疾,顿咳,牙痛,风火眼痛;外用于痄腮,乳痛。
罗汉果,味甘,性凉,归肺、大肠经,有润肺止咳、生津止渴的功效、适用于肺热或肺燥咳嗽、百日咳及暑热伤津口渴等,此外还有润肠通便的功效。
薄荷,味辛,性凉;归肺经、肝经;散风热;清头目;利咽喉;透疹;解郁。主风热表证;头痛目赤;咽喉肿痛;麻疹不透;陷疹瘙痒;肝郁胁痛。
湘莲全株,包括荷叶、荷花、荷梗、荷蒂、莲子、石莲子、莲衣、莲须、莲子心、莲房、莲壳、藕节、藕等;荷叶,味苦、涩,性平,消暑利湿,生发清阳,止血;治暑湿泄泻、眩晕、水气浮肿、雷头风、吐血、崩漏、便血等;荷花,味甘苦,性温,活血止血,祛湿消风,治跌损呕血,天泡湿疡;荷梗,味甘淡,性凉,清热解暑,通气行水,治暑湿胸闷,泄泻痢疾,淋病带下;荷蒂,味苦甘,性平;清暑祛湿,和血安胎,治泄痢,胎动不安;莲子,味甘涩,性平,养心、养肾、补脾、涩肠,治夜寐多梦、遗精、淋浊、久痢、虚泄、妇人崩漏带下;石莲子,味苦涩,性平,补脾、涩肠、养肾、养心,治遗精、淋浊、虚泻;莲衣,味苦涩、性凉,收涩止血,清热利湿,治吐血、便血、脚气、痔痢;莲须,味甘涩,性平,清心益肾、涩精止血,治梦遗、滑泄、崩带、泄痢;莲子心,味苦,性寒,清心去热、止血涩精,治心烦、口渴、吐血、遗精、目赤肿痛;莲房,味苦涩,性温,消淤、活血止血、祛湿、治血崩、月经过多、胎漏下血、瘀血腹痛、产后胎衣不下、血痢血淋、皮肤湿疮等;莲壳,味苦涩、性平,治血崩;藕节,味甘涩、性平,止血散瘀,治咳血、吐血、尿血等各种出血症;藕,味甘、性寒,清热凉血、散瘀,治热病烦渴、吐血、热淋等。
梨,味甘微酸,性凉,入肺胃经,具有生津、润燥、清热、化痰,解酒的作用;用于热病伤阴或阴虚所致的干咳、口渴、便秘等症,也可用于内热所致的烦渴、咳喘、痰黄等症。主治热嗽,止咳。治咳热,中风不语,伤寒发热,解丹石热气,惊邪。利大小便,除贼风,止心烦气喘热狂。润肺凉心,消痰降炎,解疮毒、酒毒。具有下火,治便秘功效。梨果:生津、润燥、清热、化痰等功效,适用于热病伤津烦渴、消渴症、热咳、痰热惊狂、噎膈、口渴失音、眼赤肿痛、消化不良。梨果皮:清心、润肺、降火、生津、滋肾、补阴功效。根、枝叶、花有润肺、消痰清热、解毒之功效。
与现有技术相比,本发明组方采用纯中药合理配比而成,符合中医君臣配伍及现代药理学。制玉竹降火除烦,润肺镇咳,重在滋阴;芦根味甘,性寒,清热生津,除烦止呕,用于热病烦渴、胃热呕吐、肺热咳嗽;鲜冬桑叶,祛风清热,清肝明目,主治风热兼有咳嗽,而至气粗声哑,喉燥咽痛,咯痰不爽;孔雀草,性味苦,性平,有清热利湿,清肺止咳之功效;罗汉果,性凉,味甘,清热润肺,止咳,利咽,滑肠通便。用于肺火燥咳,咽痛失音,肠燥便秘;薄荷,疏散风热,清利头目,利咽透疹,疏肝行气,主治外感风热、咽喉肿痛、食滞气胀、口疮牙痛;湘莲全株,其中生莲子肉性平偏凉,长于养心安神,用于虚烦,惊悸,失眠;莲心,具有清心火,平肝火,止血固精之功效。《随息居饮食谱》:敛液止汗,清热养神,止血固精;莲叶,《医林纂要》云:多入肝分,平热、去湿,以行清气,以青入肝也。然苦涩之味,实以泻心肝而清金固水,故能去瘀、保精、除妄热、平气血也。湘莲的梗、籽、根均具清热解暑,健胃除烦之作用。南阳梨,生津润燥,化痰止咳;以上诸药合用,走肺、胃、肝、肾四经,共奏滋阴润肺,清热生津,除烦止呕,化痰止咳之功效。
本发明的中药组合物不仅具有润肺止咳、生津止渴的功效,还具有祛燥湿化痰的功能,口味甘甜,特别适用于肺热或肺燥咳嗽、百日咳,具有清热解毒,清咽润肺、镇咳平喘的功效,对小儿久咳、成人咳血等具有良好的治疗功效,临床用之效果显著。
本发明的中药组合物的药材配伍相宜,安全性能高,服用方便,能够对肺热或肺燥咳嗽具有标本兼职的效果。
另外,本发明提供的制备方法简单,生产成本低廉,药材利用率高,对环境友好,工艺路线短,适合工业化生产。
具体实施方式
下面以具体实施例对本发明作进一步的说明,但本发明不受下述实施例的限定。本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都被视为包括在本发明。本发明的方法及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。
实施例1
润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹20份、芦根10份、鲜冬桑叶5份、孔雀草10份、南阳梨5份、罗汉果1份、薄荷1份、硬脂酸镁5份和湘莲全株40份。
制备步骤:
(1)将玉竹洗净捞出沥干,经100℃蒸汽蒸煮2h、30℃发酵12h后取出、50℃恒温通风干燥4h、100℃蒸汽蒸煮4h、30℃发酵12h后取出,切厚片,混入25%炼蜜后,85℃烘干,得制玉竹,含水量约15%。
(2)按预定重量比分别称取原料药制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、南阳梨、湘莲全株,用粉碎机粉碎至10目后,加水浸泡0.5h,所用水量为原料药体积的10倍,回流提取,时间为2.0h,过滤得滤液A和滤渣,备用;
(3)将步骤(2)所得滤渣加水浸泡1h,所用水量为原料药体积的15倍,回流提取,时间为0.5h,过滤,压榨药渣,得滤液B,备用;
(4)合并滤液A和滤液B,静置过滤,滤液减压浓缩,得到相对密度为1.25~1.30的清膏,将清膏减压干燥后,温度为50~60℃,粉碎,过80目筛,得干浸膏粉,备用;
(5)干浸膏粉置于搅拌机中,用水制成软材,将制好的软材用14~24目筛的制粒机进行制粒,在向制粒机中加软材的同时加干浸膏粉,直至制备颗粒完成;软材和干浸膏粉的重量比为3:0.5;
(6)将颗粒在鼓风干燥箱中干燥,温度为60~70℃,冷却后,喷入薄荷乙醇溶液(取预定重量比的薄荷,加入1倍体积的浓度为75%的乙醇进行回流提取1h,过滤,制得),密闭;
(7)向颗粒中加入预定重量比辅料(硬脂酸镁),混匀,用24目筛的震荡整粒机整粒筛分3次,制成24目的颗粒,将颗粒压片,即得中药组合物。
实施例2
润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹15份、芦根15份、鲜冬桑叶10份、孔雀草5份、南阳梨5份、罗汉果5份、薄荷5份、硬脂酸镁1份和湘莲全株45份。
制备步骤:
(1)将玉竹洗净捞出沥干,经100℃蒸汽蒸煮2h、30℃发酵12h后取出、50℃恒温通风干燥4h、100℃蒸汽蒸煮4h、30℃发酵12h后取出,切厚片,混入25%炼蜜后,85℃烘干,得制玉竹,含水量约15%。
(2)按预定重量比分别称取原料药制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、南阳梨、湘莲全株,用粉碎机粉碎至10目后,加水浸泡1h,所用水量为原料药体积的15倍,回流提取,时间为0.5h,过滤得滤液A和滤渣,备用;
(3)将步骤(2)所得滤渣加水浸泡0.5h,所用水量为原料药体积的10倍,回流提取,时间为2h,过滤,压榨药渣,得滤液B,备用;
(4)合并滤液A和滤液B,静置过滤,滤液减压浓缩,得到相对密度为1.25~1.30的清膏,将清膏减压干燥后,温度为40~50℃,粉碎,过80目筛,得干浸膏粉,备用;
(5)干浸膏粉置于搅拌机中,用浓度为75%的乙醇制成软材,将制好的软材用14~24目筛的制粒机进行制粒,在向制粒机中加软材的同时加干浸膏粉,直至制备颗粒完成;软材和干浸膏粉的重量比为3:1;
(6)将颗粒在鼓风干燥箱中干燥,温度为70~80℃,冷却后,喷入薄荷乙醇溶液(取预定重量比的薄荷,加入5倍体积的浓度为75%的乙醇进行回流提取0.5h,过滤,制得),密闭2h,
(7)向颗粒中加入预定重量比辅料(硬脂酸镁),混匀,用24目筛的震荡整粒机整粒筛分3次,制成24目的颗粒,将颗粒压片,即得中药组合物。
实施例3
润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹16份、芦根13份、鲜冬桑叶9份、孔雀草9份、罗汉果3份、薄荷2份、南阳梨6份、硬脂酸镁1份和湘莲全株41份。
制备步骤:
(1)将玉竹洗净捞出沥干,经100℃蒸汽蒸煮2h、30℃发酵12h后取出、50℃恒温通风干燥4h、100℃蒸汽蒸煮4h、30℃发酵12h后取出,切厚片,混入25%炼蜜后,85℃烘干,得制玉竹,含水量约15%。
(2)按预定重量比分别称取原料药制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、南阳梨、湘莲全株,用粉碎机粉碎至10目后,加水浸泡0.5h,所用水量为原料药体积的14倍,回流提取,时间为1h,过滤得滤液A和滤渣,备用;
(3)将步骤(2)所得滤渣加水浸泡0.5h,所用水量为原料药体积的12倍,回流提取,时间为1h,过滤,压榨药渣,得滤液B,备用;
(4)合并滤液A和滤液B,静置过滤,滤液减压浓缩,得到相对密度为1.25~1.30的清膏,将清膏减压干燥后,温度为60℃,粉碎,过80目筛,得干浸膏粉,备用;
(5)干浸膏粉置于搅拌机中,用浓度为75%的乙醇制成软材,将制好的软材用14~24目筛的制粒机进行制粒,在向制粒机中加软材的同时加干浸膏粉,直至制备颗粒完成;软材和干浸膏粉的重量比为6:1;
(6)将颗粒在鼓风干燥箱中干燥,温度为65℃,冷却后,喷入薄荷乙醇溶液(取预定重量比的薄荷,加入1倍体积的浓度为75%的乙醇进行回流提取1h,过滤,制得),密闭2h,
(7)向颗粒中加入预定重量比辅料(硬脂酸镁),混匀,用24目筛的震荡整粒机整粒筛分3次,制成24目的颗粒,将颗粒压片,即得中药组合物。
实施例4
润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹16份、芦根13份、鲜冬桑叶9份、孔雀草9份、罗汉果3份、薄荷2份、南阳梨6份、硬脂酸镁1份和湘莲全株41份。
制备过程同实施例1~3。
实施例5
润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹20份、芦根10份、鲜冬桑叶5份、孔雀草10份、南阳梨10份、罗汉果5份、薄荷5份、硬脂酸镁1份和湘莲全株45份。
制备过程同实施例1~3。
实施例6
润肺镇咳的中药组合物,其活性成分包括以下重量份的原料:制玉竹20份、芦根10份、鲜冬桑叶5份、孔雀草10份、南阳梨9份、罗汉果5份、薄荷5份、硬脂酸镁1份和湘莲全株40份。
制备过程同实施例1~3。
药效实验
豚鼠咳嗽模型的复制
将体重250~300g的豚鼠,雌雄兼用,于实验前3天置于20cm×10cm×10cm的透明有机密闭箱,适应60min后,用超声雾化器喷雾17.5%枸橼酸2min(雾化的颗粒大小为0.9μm,雾化流速0.6ml/min)引咳,通过呼吸流量计连接到Meblab生理信号仪记录豚鼠在7min(从枸橼酸喷雾引咳开始计时)内的咳嗽次数变化(豚鼠咳嗽和喷嚏的信号波形可以在生理仪上明显的区别开),经过训练的实验记录人员同时以豚鼠咳嗽时的躯体伸缩运动变化和咳嗽声音为标准记录豚鼠20min咳嗽次数,每只豚鼠对应的咳嗽次数作为对照数据K。咳嗽次数在10至35次的豚鼠可用于下述实验。
数据记录与统计分析
豚鼠在第一次诱导咳嗽初筛结束后第二天灌胃给药,计数豚鼠给药后的咳嗽次数Kt,药效评价指标以咳嗽的百分抑制率表示,咳嗽百分抑制率=[(K-Kt)/K]×100%。
选取合格豚鼠50只,随机分为5组,每组10只。本发明中药组合物高、中、低剂量3组;阳性对照组(磷酸可待因10mg/kg)、模型对照组(给予同体积生理盐水),在第二次引咳实验前35min分别灌胃给药,分别测试记录给药后30、60、90、120min豚鼠的咳嗽次数变化情况;低剂量给药,给药后30、60、90、120min的咳嗽%抑制率分别为:8.01%,12.94%,21.65%,10.54%;提取物中剂量给药,给药后30、60、90、120min的咳嗽%抑制率分别为15.25%,20.72%,25.02%,15.73%;高剂量给药,给药后30、60、90、120min的咳嗽%抑制率分别为:20.45%,34.86%,42.52%,31.94%。在给药后90min的镇咳效果最强,高剂量给药的咳嗽抑制率%在给药后90min时达到42.52%,咳嗽抑制率%呈现明显的剂量、时间依赖性。
临床效果
将本发明的中药组合物做成片剂成人每次两片,每日三次服用。
陈某,男,35岁,吸烟者,咳嗽、痰多,同时伴有嗓子痛,吃消炎药咳嗽症状反复,服用本发明中药组合物,三天病情痊愈,连续三周,反复次数明显降低。
李某,女,55岁,咳嗽有痰,伴有感冒嗓子痛,服用本发明中药组合物,一天后症状减轻,连续七天,病情痊愈。
张某,儿童,3岁,感冒发烧,喉咙带痰,清鼻涕,服用本发明所述中药组合物,当天退烧,三天后病情痊愈。
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,对于本领域的技术人员来说,本发明可以有各种更改和变化。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 (10)
1.一种润肺镇咳的中药组合物,其特征在于,其活性成分包括以下重量份的原料:
制玉竹15~20份、芦根10~15份、鲜冬桑叶5~10份、孔雀草5~10份、罗汉果1~5份、薄荷1~5份、南阳梨5~10份和湘莲全株40~45份。
2.根据权利要求1所述的润肺镇咳的中药组合物,其特征在于,其活性成分还包括以下重量份的原料:制玉竹16份、芦根13份、鲜冬桑叶9份、孔雀草9份、罗汉果3份、薄荷2份、南阳梨6份和湘莲全株41份。
3.根据权利要求1所述的润肺镇咳的中药组合物,其特征在于,还包含药学上可接受的辅料。
4.根据权利要求3所述的润肺镇咳的中药组合物,其特征在于,所述辅料包括稀释剂0~8份、润滑剂1~5份、矫味剂0~4份或润湿剂0~10份。
5.一种权利要求1~4任一所述的润肺镇咳的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)按预定重量比分别称取原料药制玉竹、芦根、鲜冬桑叶、孔雀草、罗汉果、南阳梨、湘莲全株,用粉碎机粉碎,加水浸泡,回流提取,过滤得滤液A和滤渣,备用;
(2)将步骤(1)所得滤渣加水浸泡,回流提取,过滤,压榨药渣,得滤液B,备用;
(3)合并滤液A和滤液B,静置过滤,滤液减压浓缩,得到清膏;将清膏减压干燥后,粉碎,过80目筛,得干浸膏粉;
(4)干浸膏粉置于搅拌机中,用水或乙醇制成软材,将制好的软材用制粒机进行制粒,在向制粒机中加软材的同时加干浸膏粉,直至制备颗粒完成;
(5)将颗粒在鼓风干燥箱中干燥,冷却后,喷入薄荷乙醇溶液,密闭;
(6)向颗粒中加入预定重量比辅料,混匀,用震荡整粒机整粒筛分,制成颗粒,将颗粒压片,即得中药组合物。
6.根据权利要求5所述的润肺镇咳的中药组合物的制备方法,其特征在于,所述步骤(1)中的制玉竹制备过程如下:将玉竹洗净捞出沥干,经第一次蒸汽蒸煮、第一次发酵、恒温通风干燥、第二次蒸汽复蒸、第二次发酵后取出,切厚片,混入炼蜜后,烘干,得制玉竹。
7.根据权利要求6所述的润肺镇咳的中药组合物的制备方法,其特征在于,所述步骤(1)中的制玉竹制备过程如下:将玉竹洗净捞出沥干,经100℃蒸汽蒸煮2h、30℃发酵12h后取出、50℃恒温通风干燥4h、100℃蒸汽蒸煮4h、30℃发酵12h后取出,切厚片,混入25%炼蜜后,85℃烘干,得制玉竹,含水量约15%。
8.根据权利要求7所述的润肺镇咳的中药组合物的制备方法,其特征在于,
所述步骤(1)中加水浸泡的时间为0.5~1h,所用水量为原料药体积的10~15倍,所述回流提取的时间为0.5~2.0h;
所述步骤(2)中加水浸泡的时间为0.5~1h,所用水量为原料药体积的10~15倍,所述回流提取的时间为0.5~2.0h;
所述步骤(3)中减压干燥的温度为40~60℃;所述清膏的相对密度为1.25~1.30;
所述步骤(5)中鼓风干燥箱中干燥的温度为60~80℃。
9.根据权利要求7所述的润肺镇咳的中药组合物的制备方法,其特征在于,所述步骤(4)中软材和干浸膏粉的重量比为3~6:0.5~1。
10.根据权利要求7所述的润肺镇咳的中药组合物的制备方法,其特征在于,所述步骤(5)中薄荷乙醇溶液的制备过程如下:取预定重量比的薄荷,加入1~5倍体积的浓度为75%的乙醇进行回流提取0.5~1h,过滤,制得。
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